Research Studies

The practitioners at The Centers for Vulvovaginal Disorders are strongly committed to research. They have been recipients of grants from The National Vulvodynia Association, The Gynecologic Cancers Research Foundation, and the Catherine Birch McCormick Foundation. Please look below to see our current research opportunities. 

Lichen Sclerosus- Platelet Rich Plasma (PRP)

Genomics and Proteomics of Lichen Sclerosus

Platelet Rich Plasma (PRP) Injections for the Treatment of Female Orgasmic Disorder

Platelet-rich plasma (PRP) is a platelet concentrate that helps to speed up tissue healing, without serious side effects, in a very wide range of medical conditions such as diabetic foot ulcers, muscle injury, tendon injury, and in a variety of cosmetic procedures. The PRP works because of its high level of proteins that help with wound healing. It is also apparent from 16,000+ published studies that PRP therapy has almost no risk of scar tissue formation or bad side effects. As the PRP is prepared from your own blood, there are no risks of allergic reactions, transfusion reactions, or infections (HIV, Hepatitis, etc).

We will be enrolling 30 women with active, biopsy proven, lichen sclerosus. The study is only being conducted at the Center for Vulvovaginal Disorders in Washington, DC. This is a double-blind placebo control study so 20 women will get the PRP, 10 will get placebo. There will be 4 study visits in a 14 weeks period. Small biopsies will be performed at the beginning and end of the study. PRP will be injected in areas of active lichen sclerosus two times during the study. No additional treatments will be allowed for four weeks prior to enrolling in the study and during the 14 weeks of the study. No compensation will be provided for participation in the trial.

If you have had problems using steroids for your lichen sclerosus, then this may be the ideal treatment for you. Please read the informed consent very carefully before contacting us. Please be aware that the Center for Vulvovaginal Disorders is the only center conducting this study and its only being conducted in our Washington DC office. If you cannot travel to Washington for the 4 visits, you will not be able participate in this study. It is also possible that you may have to come in prior to the study for one visit to confirm that you have active lichen sclerosus. 

If, after having read the informed consent, you want to participate in the study, please contact Leia Mitchell via E-mail at drg.cvvd@gmail.com. Please give a daytime and evening phone number to be contacted regarding this study.

STATUS: CLOSED. We are no longer accepting candidates for this study.

We are currently conducting a clinical study in women with lichen sclerosus to learn which genes are turned on and which genes are turned off in skin affected by LS as compared to normal skin in order to understand LS, and further to develop effective drugs to treat the condition. This study is only being conducted at the Washington DC office of the Centers for Vulvovaginal Disorders. Click here to read the informed consent to see if you are eligible.  If you are eligible, please email drg.cvvd@gmail.com.

STATUS: OPEN, Currently enrolling

Double Blind Placebo Controlled Trial of Autologous Platelet Rich Plasma (PRP) Peri-urethral and clitoral Injections for the Treatment of Female Orgasmic Disorder

Approximately one in twenty women have Female Orgasmic Disorder (FOD) and it is the second most frequently reported sexual problem in American women. FOD can either be lifelong (primary) or acquired (secondary). 

It has been suggested by many scientists that in some women FOD may be caused by decreased clitoral and genital blood flow secondary to blockage in the small blood vessels going to the clitoris (similar to that seen in erectile dysfunction (ED) in men) and/or diminished nerve conduction (also as seen in ED). PRP activates cells to develop into new tissue—nerves, collagen, and blood vessels. As such, PRP may potentially reverse the changes responsible for FOD. In addition, it has been shown that improved sexual function in women is highly linked with increased blood flow through the clitoris. One component of PRP is known to cause growth of new blood vessels. Therefore, we anticipate PRP injections may potentially improve blood flow through both the clitoris and the tissue around the urethra, thereby improving sexual function and decreasing FOD.  Please review our informed consent here and after reading the consent, you feel you are a well-qualified candidate, please complete the following form: https://www.surveymonkey.com/r/5WHGX9L 

STATUS: Open


Mona Lisa Touch for the Treatment of Lichen Sclerosus

Intrarosa for the Treatment of Genitourinary Syndrome of Menopause

Lichen sclerosus (LS) is a skin condition of the external genitals (vulva) of women. LS causes vulvar itching, pain, and burning. In addition, LS causes scarring of the vulva which may cause significant sexual dysfunction or pain. Lastly, 4-6% of women with LS will develop vulvar cancer.

The current “gold standard” treatment for lichen sclerosus is potent steroids creams. When used correctly, steroid creams help to decrease the symptoms of itching and burning and can prevent further vulvar scarring. In addition, proper treatment reverses the underlying inflammation of LS, and may lower the risk of getting cancer. While useful, steroid creams may have serious side effects that include thinning of the skin, fungal infections, and lowering the immune system.

Recently, microablative fractional CO2 laser treatment (FxCO2) (SmartXide2 V2LR laser system, for MonaLisa Touch, DEKA, Florence, Italy) has been proposed for the management of LS.  Specifically, two small studies demonstrated that FxCO2 therapy appears to be a promising treatment modality to treat lichen sclerosus. These studies demonstrated that FxCO2 treatment may stimulate tissue healing in LS. Furthermore, by reducing inflammation, the clinical symptoms of LS, such as intense itching and burning, were improved. While these studies showed good success, these studies were limited because of their small size and lack of sham (fake treatment) control.

The purpose of this study is to look at the efficacy (how well it works) and the safety of the FxCO2 laser treatment (laser energy emitted) for LS as compared to a sham treatment (very minimal laser energy will be emitted). We will be enrolling up to 40 qualified participants.  

If you are interested in participating, please carefully the informed consent.  

*If you are a well-qualified candidate as per the informed consent, please complete the following form: https://www.surveymonkey.com/r/YTDBRTJ

Tissues of the genitals of women are both androgen (testosterone) and estrogen dependent.  The clitoris, vestibule, urethra, anterior vaginal wall, peri-urethral tissue, and pelvic floor all depend on androgens for normal function. In addition, the glands, which secrete lubrication during sexual arousal, also require androgens to function. 

Deficiencies of both estrogens and androgens occur naturally during menopause.  Menopause-related deficiencies of these hormones lead to thinning in the tissues of the genital and urinary systems, termed Genitourinary Syndrome of Menopause (GSM). Patients with GSM will frequently complain of dryness and/or pain during sexual intercourse.

Historically, GSM treatment involved both androgens and estrogens, However, over the past few decades estrogen based therapies have become much more common. More recently, clinical trials have demonstrated that local vaginal dehydroepiandrosterone (Intrarosa®) improves symptoms in menopausal women who have moderate to severe pain with intercourse.   

Intrarosa® vaginal inserts are a prescription medicine approved by the U.S. Food and Drug Administration (FDA) used in women after menopause to treat moderate to severe pain during sexual intercourse caused by changes in and around the vagina that happen with menopause. We are currently recruiting 40 women to participate in this trial.  If you are interested in participating in this study, please review the informed consent.  For well qualified applicants, as per the informed consent, please complete the following form: https://www.surveymonkey.com/r/HDTZ8NL

Trial Status: Open, enrolling

HAVE A QUESTION? 

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