Other Research Studies

To view summaries of studies that are currently enrolling participants, please click on the states/country names listed below. Additional studies can be viewed at: http://www.clinicaltrials.gov/ct/search?term=vulvar+vestibulitis and http://www.clinicaltrials.gov/ct/search?term=vulvodynia

Online Studies

UBC Sexual Health Lab, (Vancouver BC)
Subject

Participants needed for an online questionnaire study examining the association between eating behaviours and sexual function, particularly with respect to chronic genital pain.

Contact

Yana Svatko at y.svatko@alumni.ubc.ca

Requirements

Participants must be female, 18 years of age or older, and have been diagnosed with Provoked Vestibulodynia, a chronic genital pain condition categorized by pain on the vulvar vestibule in response to touch. Participation involves completing an anonymous questionnaire online, which can be filled out from home and is expected to take 45 minutes. The survey contains questions about sexual function, genital pain, body image, eating habits, attitudes towards food, personality, and mood. In exchange for your time, participants will receive a $20CAD Starbucks gift card and will be entered in a draw to a $100 VISA gift card. If you have any questions about participating, please contact Yana, the Study Coordinator. If you would like to participate, the link below will take you to the online questionnaire.

Website

http://j.mp/2FUyr4B

United States

California

San Diego Sexual Medicine (San Diego, CA)
Subject

Participants Needed for a Study Designed to Evaluate the Efficacy and Safety of Dysport (Botulinum Toxin Type A) in Vulvodynia Patients

Contact

For more information please email clinical.trials@ipsen.com

Requirements

If you are a premenopausal woman over 18 years of age who has had provoked vestibulodynia for at least 6 months, but for no more than 15 years, and never had a vaginal delivery including attempted vaginal delivery, you may be eligible to participate in this study. Patients with deep pain during intercourse are not eligible to participate in this study. Participants also cannot have genitourinary conditions which may interfere with the study, previous surgery that according to investigator’s judgement may impact the study outcome (including but not limited to hysterectomy, vestibulectomy, urologic surgery, perianal surgery) or genital trauma or mutilation/cutting. Participants also must be willing to practice a highly effective form of contraception at the beginning of the study, during the study, and for a minimum of 12 weeks following the last administration of the study drug.

Website

https://clinicaltrials.gov/ct2/show/NCT03598777

Florida

Miami (FL)
Subject

Participants Needed for a Study Designed to Evaluate the Efficacy and Safety of Dysport (Botulinum Toxin Type A) in Vulvodynia Patients

Contact

For more information please email clinical.trials@ipsen.com

Requirements

If you are a premenopausal woman over 18 years of age who has had provoked vestibulodynia for at least 6 months, but for no more than 15 years, and never had a vaginal delivery including attempted vaginal delivery, you may be eligible to participate in this study. Patients with deep pain during intercourse are not eligible to participate in this study. Participants also cannot have genitourinary conditions which may interfere with the study, previous surgery that according to investigator’s judgement may impact the study outcome (including but not limited to hysterectomy, vestibulectomy, urologic surgery, perianal surgery) or genital trauma or mutilation/cutting. Participants also must be willing to practice a highly effective form of contraception at the beginning of the study, during the study, and for a minimum of 12 weeks following the last administration of the study drug.

Website

https://clinicaltrials.gov/ct2/show/NCT03598777

Clinical Research Center of Florida (Pompano Beach, FL)
Subject

Participants Needed for a Study Designed to Evaluate the Efficacy and Safety of Dysport (Botulinum Toxin Type A) in Vulvodynia Patients

Contact

For more information please email clinical.trials@ipsen.com

Requirements

If you are a premenopausal woman over 18 years of age who has had provoked vestibulodynia for at least 6 months, but for no more than 15 years, and never had a vaginal delivery including attempted vaginal delivery, you may be eligible to participate in this study. Patients with deep pain during intercourse are not eligible to participate in this study. Participants also cannot have genitourinary conditions which may interfere with the study, previous surgery that according to investigator’s judgement may impact the study outcome (including but not limited to hysterectomy, vestibulectomy, urologic surgery, perianal surgery) or genital trauma or mutilation/cutting. Participants also must be willing to practice a highly effective form of contraception at the beginning of the study, during the study, and for a minimum of 12 weeks following the last administration of the study drug.

Website

https://clinicaltrials.gov/ct2/show/NCT03598777

Illinois

University of Illinois at Chicago (Chicago, IL)
Subject

Women suffering from vulvodynia needed for study in Chicago to examine the effects of acupuncture on vulvodynia pain and symptoms.

Contact

To find out if you are eligible or if you want more information, please contact us at:

Monya Meinel
meinemo@uic.edu
312-996-5814

Requirements

We are looking for women suffering from vulvodynia or vulvar pain to participate in a research study looking at whether acupuncture can help manage vulvodynia pain. The study includes 10 acupuncture treatments over 5 weeks, and will be conducted at the University of Illinois at Chicago College of Nursing and other locations in North Chicago and Wilmette. There are no acupuncture points in the genital area. Women who are 18 years of age or older who have vulvodynia pain and are not pregnant may qualify to join the study. If you are interested in joining the study, please contact us to see if you are eligible to participate. Visit our website for more information and study locations.

Website

http://vulvodyniastudy.uic.edu/

Missouri

University of Kansas Medical Center Recruiting (Kansas City, MO)
Subject

Participants Needed for a Study Designed to Evaluate the Efficacy and Safety of Dysport (Botulinum Toxin Type A) in Vulvodynia Patients

Contact

For more information please email clinical.trials@ipsen.com

Requirements

If you are a premenopausal woman over 18 years of age who has had provoked vestibulodynia for at least 6 months, but for no more than 15 years, and never had a vaginal delivery including attempted vaginal delivery, you may be eligible to participate in this study. Patients with deep pain during intercourse are not eligible to participate in this study. Participants also cannot have genitourinary conditions which may interfere with the study, previous surgery that according to investigator’s judgement may impact the study outcome (including but not limited to hysterectomy, vestibulectomy, urologic surgery, perianal surgery) or genital trauma or mutilation/cutting. Participants also must be willing to practice a highly effective form of contraception at the beginning of the study, during the study, and for a minimum of 12 weeks following the last administration of the study drug.

Website

https://clinicaltrials.gov/ct2/show/NCT03598777

Nebraska

Omaha OB-GYN Associates, PC (Omaha, NE)
Subject

Participants Needed for a Study Designed to Evaluate the Efficacy and Safety of Dysport (Botulinum Toxin Type A) in Vulvodynia Patients

Contact

For more information please email clinical.trials@ipsen.com

Requirements

If you are a premenopausal woman over 18 years of age who has had provoked vestibulodynia for at least 6 months, but for no more than 15 years, and never had a vaginal delivery including attempted vaginal delivery, you may be eligible to participate in this study. Patients with deep pain during intercourse are not eligible to participate in this study. Participants also cannot have genitourinary conditions which may interfere with the study, previous surgery that according to investigator’s judgement may impact the study outcome (including but not limited to hysterectomy, vestibulectomy, urologic surgery, perianal surgery) or genital trauma or mutilation/cutting. Participants also must be willing to practice a highly effective form of contraception at the beginning of the study, during the study, and for a minimum of 12 weeks following the last administration of the study drug.

Website

https://clinicaltrials.gov/ct2/show/NCT03598777

New Jersey

Rutgers, Robert Wood Johnson Medical School (New Brunswick, NJ)
Subject

Participants Needed for a Study Designed to Evaluate the Efficacy and Safety of Dysport (Botulinum Toxin Type A) in Vulvodynia Patients

Contact

For more information please email clinical.trials@ipsen.com

Requirements

If you are a premenopausal woman over 18 years of age who has had provoked vestibulodynia for at least 6 months, but for no more than 15 years, and never had a vaginal delivery including attempted vaginal delivery, you may be eligible to participate in this study. Patients with deep pain during intercourse are not eligible to participate in this study. Participants also cannot have genitourinary conditions which may interfere with the study, previous surgery that according to investigator’s judgement may impact the study outcome (including but not limited to hysterectomy, vestibulectomy, urologic surgery, perianal surgery) or genital trauma or mutilation/cutting. Participants also must be willing to practice a highly effective form of contraception at the beginning of the study, during the study, and for a minimum of 12 weeks following the last administration of the study drug.

Website

https://clinicaltrials.gov/ct2/show/NCT03598777

Morristown (NJ)
Subject

Participants Needed for a Study Designed to Evaluate the Efficacy and Safety of Dysport (Botulinum Toxin Type A) in Vulvodynia Patients

Contact

For more information please email clinical.trials@ipsen.com

Requirements

If you are a premenopausal woman over 18 years of age who has had provoked vestibulodynia for at least 6 months, but for no more than 15 years, and never had a vaginal delivery including attempted vaginal delivery, you may be eligible to participate in this study. Patients with deep pain during intercourse are not eligible to participate in this study. Participants also cannot have genitourinary conditions which may interfere with the study, previous surgery that according to investigator’s judgement may impact the study outcome (including but not limited to hysterectomy, vestibulectomy, urologic surgery, perianal surgery) or genital trauma or mutilation/cutting. Participants also must be willing to practice a highly effective form of contraception at the beginning of the study, during the study, and for a minimum of 12 weeks following the last administration of the study drug.

Website

https://clinicaltrials.gov/ct2/show/NCT03598777

New York

The Center for Vulvovaginal Disorders (New York, NY)
Subject

Participants Needed for a Study Designed to Evaluate the Efficacy and Safety of Dysport (Botulinum Toxin Type A) in Vulvodynia Patients

Contact

For more information please email clinical.trials@ipsen.com

Requirements

If you are a premenopausal woman over 18 years of age who has had provoked vestibulodynia for at least 6 months, but for no more than 15 years, and never had a vaginal delivery including attempted vaginal delivery, you may be eligible to participate in this study. Patients with deep pain during intercourse are not eligible to participate in this study. Participants also cannot have genitourinary conditions which may interfere with the study, previous surgery that according to investigator’s judgement may impact the study outcome (including but not limited to hysterectomy, vestibulectomy, urologic surgery, perianal surgery) or genital trauma or mutilation/cutting. Participants also must be willing to practice a highly effective form of contraception at the beginning of the study, during the study, and for a minimum of 12 weeks following the last administration of the study drug.

Website

https://clinicaltrials.gov/ct2/show/NCT03598777

The Arthur Smith Institute for Urology (New York, NY)
Subject

Participants Needed for a Study Designed to Evaluate the Efficacy and Safety of Dysport (Botulinum Toxin Type A) in Vulvodynia Patients

Contact

For more information please email clinical.trials@ipsen.com

Requirements

If you are a premenopausal woman over 18 years of age who has had provoked vestibulodynia for at least 6 months, but for no more than 15 years, and never had a vaginal delivery including attempted vaginal delivery, you may be eligible to participate in this study. Patients with deep pain during intercourse are not eligible to participate in this study. Participants also cannot have genitourinary conditions which may interfere with the study, previous surgery that according to investigator’s judgement may impact the study outcome (including but not limited to hysterectomy, vestibulectomy, urologic surgery, perianal surgery) or genital trauma or mutilation/cutting. Participants also must be willing to practice a highly effective form of contraception at the beginning of the study, during the study, and for a minimum of 12 weeks following the last administration of the study drug.

Website

https://clinicaltrials.gov/ct2/show/NCT03598777

SoHo Gynecology (New York City, NY)
Subject

Study For Postmenopausal Women with Secondary Provoked Vestibulodynia Not Using Estrogen

Contact

Please contact Amy Meadow, PA, by email at ameadowpa@gmail.com to ask about the study and whether you are eligible to participate. Please remember to leave your contact information and best time to reach you. There are certain reasons why you may not be able to participate in the study including certain medical conditions or medications that you might be taking. You may request and receive a copy of the Consent form along with the questionnaires that you will be asked to fill out. Please read the Informed Consent carefully, to be sure that you will feel comfortable participating in the study.

Requirements

We will be enrolling a limited number of women with provoked vestibulodynia to participate in the study. The women must be experiencing significant to severe pain. (7-10 on a 0-10 pain scale) when touching their vulvar vestibule. Studying women with this degree of pain will make it possible to detect whether applying 5% sinecatechins ointment is significantly more effective than applying a placebo ointment.

This is a placebo- controlled study which means that there is a 50/50 chance of receiving the study drug (5% sinecatechins) and a 50/50 chance of receiving a placebo ointment. It is “double blinded study” because neither the study participant nor Dr. Dena Harris , Dr. Lila Nachtigall or Amy Meadow, PA will know whether participants are receiving the study drug or the placebo until the end of the study. Once a woman is accepted to join the study, they will be asked to complete the entire study protocol. Please do not consider applying to join the study if you cannot promise to complete the course of the study, regardless of whether or not you feel an improvement.

There is no cost to the participants to participate in the study. There is no cost to the participants for the office visits or the study drug/placebo. Please note that the study is not meant to take the place of the participant’s routine gynecologic care and participants are expected to continue to be under the care of their own healthcare provider(s).
There will be three visits with Dr. Dena Harris over a period of six weeks, plus weekly questionnaires to fill out online. Since much of this is to be done by e-mail, each participant must have access to a computer to join the study.

Each woman will be asked to apply a small amount of topical ointment to the areas discussed with Dr. Harris at their first office visit. The ointment will be identified by a code only. The participants in the study will not know if they are receiving the study drug or the placebo. They will be asked to use a small amount of the ointment, that they receive, once a day, every day, for six weeks because the ointment may take some time before causing improvement compared to the placebo.

Each participant in the study, will be seen three (3) times in Dr. Dena Harris’ office over a period of 6 weeks. After their first visit they will be seen two more times by Dr. Harris, at the end of 3 weeks and at the end of 6 weeks. At each of these three visits Dr. Harris will perform a speculum exam and examine the vulvar area to detect any changes in appearance or signs of irritation.

At each visit, the participant will have a Q-tip test in which a cotton Q-tip will touch several areas on their vestibule to assess and score their degree of discomfort. On each of the three in office visits, the participant will be asked to complete questionnaires about her symptoms and sexual function.

Each participant will receive an email reminder at the end of week 1, 2, 4 and 5 asking them to fill out two short questionnaires online. Instructions will be given. At the end of six weeks, each participant will be seen for the last office study visit and exam with Dr. Harris. They will stop using their tube of ointment. Nothing more is required of them until 12 weeks. After the 12th week each participant will receive an email requesting that they fill out the final set of questionnaires. This is important to determine the durability of the effects, benefits, that they may have experienced.

Please do not make an appointment to participate in the study unless you have been asked to do so by either Dr. Dena Harris or Amy Meadow, PA to avoid coming to an appointment only to find out that you do not qualify to join the study. There is a limited number of participants that can be enrolled in the study and therefore there is no guarantee that you will be enrolled in the study even if you qualify.

We hope that you are completely satisfied that you understand the study. Again, if you have any questions about the study please email Amy Meadow, PA at ameadowpa@gmail.com. Thank you for your interest in this study on the potential use of 5% sinecatechins ointment for the alleviation of secondary provoked vestibulodynia in post -menopausal women not taking exogenous hormones.

Website

https://clinicaltrials.gov/ct2/results?term=NCT03682601&Search=Search

New Hyde Park (NY)
Subject

Participants Needed for a Study Designed to Evaluate the Efficacy and Safety of Dysport (Botulinum Toxin Type A) in Vulvodynia Patients

Contact

For more information please email clinical.trials@ipsen.com

Requirements

If you are a premenopausal woman over 18 years of age who has had provoked vestibulodynia for at least 6 months, but for no more than 15 years, and never had a vaginal delivery including attempted vaginal delivery, you may be eligible to participate in this study. Patients with deep pain during intercourse are not eligible to participate in this study. Participants also cannot have genitourinary conditions which may interfere with the study, previous surgery that according to investigator’s judgement may impact the study outcome (including but not limited to hysterectomy, vestibulectomy, urologic surgery, perianal surgery) or genital trauma or mutilation/cutting. Participants also must be willing to practice a highly effective form of contraception at the beginning of the study, during the study, and for a minimum of 12 weeks following the last administration of the study drug.

Website

https://clinicaltrials.gov/ct2/show/NCT03598777

North Carolina

University of North Carolina School of Medicine (Chapel Hill, NC)
Subject

A Necessary Multi-Parametric Evaluation of Vulvodynia

Contact

If you are interested in taking part in this study, please go to the following page http://www.med.unc.edu/ppru/research and click on the “Registry” link at the bottom of the page.

Requirements

Women between the ages of 21 and 75 who have been diagnosed by their doctor with vulvodynia and/or experience pain in the vaginal region upon contact (ie. tampon use, intercourse, or pelvic exam) or without contact, for at least 3 months, may be eligible to participate in this study.

The research study involves undergoing sensory testing, a modified gynecological exam and will require 3 visits to the University of North Carolina. Participants will receive up to $200 for complete participation. The purpose of this study is to get a better understanding of a chronic pain syndrome called vulvodynia, or pain in the vulvar (pelvic) region.

Website

http://www.med.unc.edu/ppru/research/current-research-1/a-necessary-multi-parametric-evaluation-of-vulvodynia

Ohio

University of Cincinnati-Center for Reproductive Health (Cincinnati, OH)
Subject

Participants Needed for a Study Designed to Evaluate the Efficacy and Safety of Dysport (Botulinum Toxin Type A) in Vulvodynia Patients

Contact

For more information please email clinical.trials@ipsen.com

Requirements

If you are a premenopausal woman over 18 years of age who has had provoked vestibulodynia for at least 6 months, but for no more than 15 years, and never had a vaginal delivery including attempted vaginal delivery, you may be eligible to participate in this study. Patients with deep pain during intercourse are not eligible to participate in this study. Participants also cannot have genitourinary conditions which may interfere with the study, previous surgery that according to investigator’s judgement may impact the study outcome (including but not limited to hysterectomy, vestibulectomy, urologic surgery, perianal surgery) or genital trauma or mutilation/cutting. Participants also must be willing to practice a highly effective form of contraception at the beginning of the study, during the study, and for a minimum of 12 weeks following the last administration of the study drug.

Website

https://clinicaltrials.gov/ct2/show/NCT03598777

The Christ Hospital-Urogynecology (West Chester, OH)
Subject

Participants Needed for a Study Designed to Evaluate the Efficacy and Safety of Dysport (Botulinum Toxin Type A) in Vulvodynia Patients

Contact

For more information please email clinical.trials@ipsen.com

Requirements

If you are a premenopausal woman over 18 years of age who has had provoked vestibulodynia for at least 6 months, but for no more than 15 years, and never had a vaginal delivery including attempted vaginal delivery, you may be eligible to participate in this study. Patients with deep pain during intercourse are not eligible to participate in this study. Participants also cannot have genitourinary conditions which may interfere with the study, previous surgery that according to investigator’s judgement may impact the study outcome (including but not limited to hysterectomy, vestibulectomy, urologic surgery, perianal surgery) or genital trauma or mutilation/cutting. Participants also must be willing to practice a highly effective form of contraception at the beginning of the study, during the study, and for a minimum of 12 weeks following the last administration of the study drug.

Website

https://clinicaltrials.gov/ct2/show/NCT03598777

Cleveland Clinic (Cleveland, OH)
Subject

Participants Needed for a Study Designed to Evaluate the Efficacy and Safety of Dysport (Botulinum Toxin Type A) in Vulvodynia Patients

Contact

For more information please email clinical.trials@ipsen.com

Requirements

If you are a premenopausal woman over 18 years of age who has had provoked vestibulodynia for at least 6 months, but for no more than 15 years, and never had a vaginal delivery including attempted vaginal delivery, you may be eligible to participate in this study. Patients with deep pain during intercourse are not eligible to participate in this study. Participants also cannot have genitourinary conditions which may interfere with the study, previous surgery that according to investigator’s judgement may impact the study outcome (including but not limited to hysterectomy, vestibulectomy, urologic surgery, perianal surgery) or genital trauma or mutilation/cutting. Participants also must be willing to practice a highly effective form of contraception at the beginning of the study, during the study, and for a minimum of 12 weeks following the last administration of the study drug.

Website

https://clinicaltrials.gov/ct2/show/NCT03598777

Pennsylvania

Center for Pelvic Medicine (Bryn Mawr, PA)
Subject

Participants Needed for a Study Designed to Evaluate the Efficacy and Safety of Dysport (Botulinum Toxin Type A) in Vulvodynia Patients

Contact

For more information please email clinical.trials@ipsen.com

Requirements

If you are a premenopausal woman over 18 years of age who has had provoked vestibulodynia for at least 6 months, but for no more than 15 years, and never had a vaginal delivery including attempted vaginal delivery, you may be eligible to participate in this study. Patients with deep pain during intercourse are not eligible to participate in this study. Participants also cannot have genitourinary conditions which may interfere with the study, previous surgery that according to investigator’s judgement may impact the study outcome (including but not limited to hysterectomy, vestibulectomy, urologic surgery, perianal surgery) or genital trauma or mutilation/cutting. Participants also must be willing to practice a highly effective form of contraception at the beginning of the study, during the study, and for a minimum of 12 weeks following the last administration of the study drug.

Website

https://clinicaltrials.gov/ct2/show/NCT03598777

Tennessee

Women's Institute for Sexual Health (Nashville, TN)
Subject

Participants Needed for a Study Designed to Evaluate the Efficacy and Safety of Dysport (Botulinum Toxin Type A) in Vulvodynia Patients

Contact

For more information please email clinical.trials@ipsen.com

Requirements

If you are a premenopausal woman over 18 years of age who has had provoked vestibulodynia for at least 6 months, but for no more than 15 years, and never had a vaginal delivery including attempted vaginal delivery, you may be eligible to participate in this study. Patients with deep pain during intercourse are not eligible to participate in this study. Participants also cannot have genitourinary conditions which may interfere with the study, previous surgery that according to investigator’s judgement may impact the study outcome (including but not limited to hysterectomy, vestibulectomy, urologic surgery, perianal surgery) or genital trauma or mutilation/cutting. Participants also must be willing to practice a highly effective form of contraception at the beginning of the study, during the study, and for a minimum of 12 weeks following the last administration of the study drug.

Website

https://clinicaltrials.gov/ct2/show/NCT03598777

Texas

Texas Tech University Health Sciences Center (Midland, TX)
Subject

A Prospective Longitudinal Data Bank Creation to Study Vaginal Conditions With a Novel Diagnostic Approach

Contact

For more information please contact Jennifer R Hinojosa, RN, by phone 432-335-5113  or email  jennifer.hinojosa@ttuhsc.edu  

Requirements

The purpose of this study is to identify and elucidate the pattern and perhaps role of atypical proteins, cytokines and vaginal microbial flora in the pathogenic mechanisms involved in the development of vulvodynia, recurrent fungal and bacterial vaginosis and preterm labor.


Eligibility
Ages Eligible for Study:  
21 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:  
Female
Accepts Healthy Volunteers:  
Yes


Sampling Method:  
Non-Probability Sample


Study Population
All patients willing to participate, and give informed consent, and Asymptomatic, non-pregnant, healthy women ages 21 to 75 years with no previous history of any chronic or recurrent vulvovaginal condition who attend our clinical offices for their annual well-woman physical examination.
2—Non-pregnant women ages 21 to 75 years being evaluated for any gynecological vulvovaginal condition.
Pregnant women ages 21 to 75 years who are both asymptomatic and healthy Pregnant women ages 21 to 75 who have any gynecological vulvovaginal condition


Criteria
Inclusion Criteria:
All patients willing to participate, and give informed consent, and
Asymptomatic, non-pregnant, healthy women ages 21 to 75 years with no previous history of any chronic or recurrent vulvovaginal condition who attend our clinical offices for their annual well-woman physical examination.
Non-pregnant women ages 21 to 75 years being evaluated for any gynecological vulvovaginal condition.
Pregnant women ages 21 to 75 years who are both asymptomatic and healthy
Pregnant women ages 21 to 75 who have any gynecological vulvovaginal condition
Exclusion Criteria:
Asymptomatic patients ages < 21 or > 75, or symptomatic patients ages < 21 or > 75 years.
Patients diagnosed with cancer or having any medical condition that is not under control including: diabetes mellitus, hypertension, collagen disease, hemoglobinopathy, renal insufficiency, depression, anxiety, psychosis and panic attacks
Patients unable to follow the protocol or unwilling to participate

Website

https://clinicaltrials.gov/ct2/show/NCT01829204?term=vulvodynia&rank=34

Virginia

McLean Center for Complementary and Alternative Medicine (Vienna, VA)
Subject

Effect of Two Acupuncture Protocols on Vulvodynia (Acu/Vul-pain)

Contact

For more information, or if you are interested in participating in this study, please contact Arthur Y Fan, MD (CHN), PhD by phone 703-499-4428 or email ArthurFan@ChineseMedicineDoctor.us

Requirements

You may be eligible to participate in this study if you are a women between the ages of 18 and 45, have been diagnosed with generalized and/or provoked vestibulodynia by an OB/GYN or pain specialist and have a current pain score higher than 4 with tampon insertion and removal, or cotton swab test at the initial screen test. Participants must be able to speak and read either English or Chinese.

This study evaluates acupuncture for the treatment of vulvodynia; specifically, if it reduces vulvar pain, pain duration and pain with intercourse. It also examines how long the effect of acupuncture lasts in women with vulvodynia. One-third of the women will receive acupuncture focused on pudendal nerve distribution area; another one-third of the women will receive acupuncture focused on traditional meridian points; the other one-third of women will receive standard care (without acupuncture). Women who experience a reduction in pain (included in subjective and objective scores) will have their pain monitored once a week for up to 6 weeks to see if the acupuncture effect lasts.

Exclusion Criteria:

1. infectious conditions of the vulva/vagina;
2. inflammatory conditions of the vulva/vagina;
3. neoplastic disorders of the vulva/vagina;
4. neurologic disorders of the vulva/vagina;
5. acute trauma to the genitals;
6. iatrogenic conditions of the genitals
7. hormonal deficiencies
8. co-morbid pelvic pain conditions (to avoid confounding pain outcomes) such as pelvic inflammatory disease and documented history of endometriosis
9. menopause
10. patients who have active migraine headaches, temporomandibular joint disease (TMJ), irritable bowel syndrome (IBS), interstitial cystitis, painful bladder syndrome, or fibromyalgia, in past 6 month.

Website

https://clinicaltrials.gov/ct2/show/study/NCT03481621#contacts

Washington

Seattle Women's: Health, Research, Gynecology (Seattle, WA)
Subject

Participants Needed for a Study Designed to Evaluate the Efficacy and Safety of Dysport (Botulinum Toxin Type A) in Vulvodynia Patients

Contact

For more information please email clinical.trials@ipsen.com

Requirements

If you are a premenopausal woman over 18 years of age who has had provoked vestibulodynia for at least 6 months, but for no more than 15 years, and never had a vaginal delivery including attempted vaginal delivery, you may be eligible to participate in this study. Patients with deep pain during intercourse are not eligible to participate in this study. Participants also cannot have genitourinary conditions which may interfere with the study, previous surgery that according to investigator’s judgement may impact the study outcome (including but not limited to hysterectomy, vestibulectomy, urologic surgery, perianal surgery) or genital trauma or mutilation/cutting. Participants also must be willing to practice a highly effective form of contraception at the beginning of the study, during the study, and for a minimum of 12 weeks following the last administration of the study drug.

Website

https://clinicaltrials.gov/ct2/show/NCT03598777

Washington DC

MedStar Washington Hospital Center (Washington, DC)
Subject

Clinical Trial Comparing the Safety and Efficacy of Clobetasol Proprionate (Temovate) to the Mona Lisa Radiofrequency C02 Laser in Treatment of Symptomatic Lichen Sclerosus.

Contact

For more information, please visit:
(https://clinicaltrials.gov/ct2/show/NCT02573883?term=NCT02573883&rank=1).

Primary Investigator: Dr.Cheryl Iglesia, Cheryl.Iglesia@medstar.net, 202-877-6526
Research Coordinator: Joanna Peterson, Joanna.L.Peterson@medstar.net, 202-877-0526

Requirements

If you are a postmenopausal women who has been diagnosed with Lichen Sclerosus, and bothered by symptoms such as vulvar itching, discomfort, bleeding or blisters, you may be eligible to participate in this study. Participants must speak and read english and be able to attend 5 clinic appointments at MedStar Washington Hospital Center/National Center for Advanced Pelvic Surgery in Washington DC. You cannot be enrolled in the study if you have history of gynecologic malignancy, pelvic radiation, active genital infection, severe pelvic organ prolapse, or vaginal mesh.


If you qualify, you will be randomized to treatment with Clobetasol Proprionate or C02 radiofrequency laser therapy. You will be asked to complete questionnaires about your symptoms. Participants will pay the standard rate for a clinic visit but will not be charged for the laser treatment. Participants will receive a $30 Target gift card at the end of trial participation.


Location: Medstar Washington Hospital Center, Female Pelvic Medicine and Reproductive Surgery Office Washington, DC

James A. Simon, MD, PC (Washington, DC)
Subject

Participants Needed for a Study Designed to Evaluate the Efficacy and Safety of Dysport (Botulinum Toxin Type A) in Vulvodynia Patients

Contact

For more information please email clinical.trials@ipsen.com

Requirements

If you are a premenopausal woman over 18 years of age who has had provoked vestibulodynia for at least 6 months, but for no more than 15 years, and never had a vaginal delivery including attempted vaginal delivery, you may be eligible to participate in this study. Patients with deep pain during intercourse are not eligible to participate in this study. Participants also cannot have genitourinary conditions which may interfere with the study, previous surgery that according to investigator’s judgement may impact the study outcome (including but not limited to hysterectomy, vestibulectomy, urologic surgery, perianal surgery) or genital trauma or mutilation/cutting. Participants also must be willing to practice a highly effective form of contraception at the beginning of the study, during the study, and for a minimum of 12 weeks following the last administration of the study drug.

Website

https://clinicaltrials.gov/ct2/show/NCT03598777

Center for Vulvovaginal Disorders (Washington, DC)
Subject

Participants Needed for a Study Designed to Evaluate the Efficacy and Safety of Dysport (Botulinum Toxin Type A) in Vulvodynia Patients

Contact

For more information please email clinical.trials@ipsen.com

Requirements

If you are a premenopausal woman over 18 years of age who has had provoked vestibulodynia for at least 6 months, but for no more than 15 years, and never had a vaginal delivery including attempted vaginal delivery, you may be eligible to participate in this study. Patients with deep pain during intercourse are not eligible to participate in this study. Participants also cannot have genitourinary conditions which may interfere with the study, previous surgery that according to investigator’s judgement may impact the study outcome (including but not limited to hysterectomy, vestibulectomy, urologic surgery, perianal surgery) or genital trauma or mutilation/cutting. Participants also must be willing to practice a highly effective form of contraception at the beginning of the study, during the study, and for a minimum of 12 weeks following the last administration of the study drug.

Website

https://clinicaltrials.gov/ct2/show/NCT03598777

Canada

British Columbia

University of British Columbia (Vancouver, BC)
Subject

Physiotherapy Intervention for Provoked Vulvar Vestibulodynia

Contact

For more information please contact Marcy L Dayan, BSc Rehab, by phone 604-739-3133 or email dayanphysio@telus.net

Requirements

Purpose
Hypothesis:
Specific physiotherapy interventions will decrease pain, improve pelvic floor motor control, increase self efficacy, improve sexual function and decrease pain catastrophizing behaviour in women with provoked vulvar vestibulodynia. This study will look at specific physiotherapy treatment interventions to see if they decrease pain, improve pelvic floor motor control, increase self efficacy, improve sexual function and decrease pain catastophizing behaviour. Participants will fill out a questionnaire on their pain symptoms and complete standardized scales prior to starting treatment and after 4 sessions to determine change due to interventions.
A combination of physiotherapy, group educational sessions and group cognitive behavioural therapy will have better outcomes than physiotherapy alone.
Results of physiotherapy intervention alone will be compared to results of those treated with physiotherapy, group educational sessions and group cognitive behavioural therapy at a separate treatment centre. Physiotherapy interventions and outcome measures are the same between both groups.
Justification:
Standard treatment is hard to identify as many approaches are taken, none with any evidence to support them. This study aims to look at specific techniques (pelvic floor coordination and relaxation exercises, education on female sexual response and pain pathophysiology education) to see if there is a benefit.


Eligibility
Ages Eligible for Study:  
16 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:  
Female
Accepts Healthy Volunteers:  
No


Criteria
Inclusion Criteria:
40 years and under
diagnosis of provoked vulvar vestibulodynia
Exclusion Criteria:
early menopause
have had a total or partial hysterectomy
are on estrogen suppression medication
have a primary arousal disorder
declined admission to the Multidisciplinary Vulvodynia Program at Vancovuer General Hospital

Website

https://clinicaltrials.gov/ct2/show/NCT01628679?term=vulvodynia&rank=33

Abroad

France

Hôpital Tenon (Paris, France)
Subject

A Pilot Study of the Effects of Botulinum Toxin in the Treatment of Provoked Vestibulodynia (VESTIBULE)

Contact

For more information contact Frédérique Lebreton, MD, by email frederique.lebreton@tnn.aphp.fr   

Requirements

The main objective of this study is to compare the efficacy of botulinum toxin injections on vestibulodynia pain compared to a group treated with a placebo.


Eligibility
Ages Eligible for Study:
18 Years to 60 Years (Adult)
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No


Criteria
Inclusion Criteria:
Subject refractory to conventional treatments (tricyclic antidepressants and benzodiazepines at analgesic doses, biofeedback physical therapy)
Negative screening test results
Notified associated factors
Menopause, surgically sterilized women or women using effective contraceptive method
Good understanding and predictable adherence to the protocol
beneficiary/affiliated to French social security/social healthcare
signed Informed Consent Form
Exclusion Criteria:
Predictable poor adherence
Pregnant or breastfeeding women
Myasthenia
Treatment with aminoglycosides
Major mental disorders
Underlying etiology
Vulnerable subjects (particularly adults under guardianship)
Any reason deemed relevant by the investigator
Current or former (in the last 3 months) participation to another clinical trial

Website

https://clinicaltrials.gov/ct2/show/NCT02858219?term=vulvodynia&rank=51

Sweden

Akademiska Hospital (Uppsala, Sweden)
Subject

The EMBLA Project – An Internet-based Intervention as a Supplement to Clinical Management for Vulvodynia Patients

Contact

For more information please contact Alkistis Skalkidou, MD, PhD, by phone 046-186110000 or email alkistis.skalkidou@kbh.uu.se

Requirements

Vulvodynia is a very common but vastly under-diagnosed and under-treated gynaecological condition that leads to extreme suffering for both the women involved but also their partners. It has also been shown to be associated with poor quality of life, leading to depression and anxiety states. When left untreated, the condition takes a very long time to resolve, with a substantial associated disability and suffering. Both psycho-education and internet-based interventions have been shown to be highly successful while they can be quite affordable. This makes them highly cost-effective. The present study aims at evaluating the effectiveness of such an intervention among a vulvodynia patient population from the clinics of Uppsala, Falun, Orebro and Gävle. The patients will be recruited by treating physicians and given access to the internet-based platform, where they will fill out questionnaires during four different time-points, after randomization to the control or the intervention group. The intervention group will also have access to multiple activities and information material uploaded in the internet-based platform. Differences in pain, quality of life and mental health parameter outcomes will be assessed at the end of the study. Should this intervention prove effective, it will be implemented in clinical praxis in the four regions.


Eligibility
Ages Eligible for Study:  
Child, Adult, Senior
Sexes Eligible for Study:  
Female
Accepts Healthy Volunteers:  
Yes


Criteria
Inclusion Criteria:
Vulvodynia patients at their initial evaluation visit to a physician providing written informed consent for participation in the study
Exclusion Criteria:
inability to read and understand Swedish
severe mental illness
currently in treatment for vulvodynia

Website

https://clinicaltrials.gov/ct2/show/NCT02809612?term=vulvodynia&rank=5