Testosterone + Estrogen for Vulvodynia

Not yet recruiting at 1 trial location

Overseen By Gisele Moran, MD, MPH

Age: 18+

Sex: Female

Trial Phase: Phase 2 & 3

Sponsor: TriHealth Inc.

Must be taking: Topical estrogen

Must not be taking: Anti-androgens, other topical hormones

Disqualifiers: Active infection, Pregnancy, Breast-feeding

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a combination of testosterone and estrogen creams can more effectively reduce pain during vaginal penetration for individuals with vulvodynia, compared to estrogen cream alone. Vulvodynia is a chronic pain condition affecting the vulva, often causing discomfort during sex. Suitable participants are those who regularly experience this type of pain and rate it at least a 4 out of 10. The trial includes two groups: one using the standard estrogen treatment and another using both testosterone and estrogen. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I need to stop my current medications to join the trial?

You will need to stop taking any anti-androgenic medications (like finasteride or dutasteride) and stop using any other topical hormones on the vulva or vagina to join the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that using a mix of testosterone and estrogen for vulvodynia is generally safe. One study found no major changes in hormone or metabolism levels after 12 weeks of treatment. Another study reported no change in the thickness of the uterus lining, suggesting the treatment doesn't affect it. These findings indicate that the treatment is well-tolerated.

Some studies also show improvements in symptoms like vulvar pain and pain during sex. However, there isn't enough information on the long-term safety of testosterone use in women. Overall, current evidence suggests the treatment is safe for short-term use, but more research is needed to confirm its long-term safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for vulvodynia?

Researchers are excited about the Testosterone and Estrogen combination treatment for vulvodynia because it offers a novel approach compared to the current standard options, like topical anesthetics and antidepressants. Unlike traditional treatments that mainly focus on symptom relief, this combination addresses hormonal imbalances that might contribute to vulvodynia. By directly targeting hormonal pathways, it has the potential to tackle the root causes of pain and discomfort, offering a more comprehensive solution for patients.

What evidence suggests that this trial's treatments could be effective for vulvodynia?

Research has shown that a mix of testosterone and estrogen can help reduce vulvar pain. Studies have found significant pain reduction after treatment with these hormones. For example, one study found that this combination alleviated pain from vaginal atrophy, which often causes pain during sex. Another study with premenopausal women noted less vulvar pain when using a cream with estradiol and testosterone. In this trial, participants will receive either the testosterone and estrogen combination or the standard of care. These findings suggest that using testosterone and estrogen together might ease pain for people with vulvodynia. ^{4 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for individuals experiencing vulvodynia or pain during intercourse, possibly due to conditions like Lichen Sclerosus. Participants should not have other medical issues that could interfere with the study.

Inclusion Criteria

I am 18 years old or older.

I experience significant pain during vaginal penetration.

Exclusion Criteria

Pregnancy

Breast-feeding

I am taking medication for hormone therapy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either topical testosterone and estrogen or estrogen alone

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Testosterone and Estrogen Combination

Trial Overview

The study aims to determine if using a combination of topical testosterone and estrogen cream provides better pain relief during vaginal penetration than using topical estrogen cream alone.

How Is the Trial Designed?

Group I: Treatment Experimental Treatment 1 Intervention

Patients receiving study treatment

Group II: Standard of care Active Control 1 Intervention

Patients receiving standard of care

Who Is Running the Clinical Trial?

TriHealth Inc.

Lead Sponsor

Trials

103

Recruited

54,100+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4184715/

The Treatment of Vestibulodynia with Topical Estradiol and ...

There was a statistically significant improvement in posttreatment vestibular pain scores (P = 0.001), SHBG (P = 0.001), and calculated free ...

2.

vulvodynia.com

vulvodynia.com/assets/files/treatment_of_vestibulodynia_with_estradiol_and_testosterone.pdf

The Treatment of Vestibulodynia with Topical Estradiol and ...

Testosterone was used in treatment as a recent study examining the impact of vaginal testosterone alone on vaginal atrophy demonstrated improve- ment in vaginal ...

3.

gremjournal.com

gremjournal.com/journal/03-2021/hormonal-contraception-and-vulvodynia-an-update/

Hormonal contraception and vulvodynia: an update

Hormonal contraception may change vulvovaginal morphology by increasing vascular resistance and causing atrophy, reduced elasticity and hypolubrication.

4.

imrpress.com

imrpress.com/journal/CEOG/48/4/10.31083/j.ceog4804128/htm

Treatment of vulvar pain caused by atrophy: a systematic ...

The combination of estriol and testosterone propionate 2% for 12 weeks showed an improve of Vulvar pain due to atrophy (VPA) and dyspareunia in a descriptive ...

5.

onlinelibrary.wiley.com

onlinelibrary.wiley.com/doi/10.1111/jmwh.13456

Evaluation and Treatment of Vulvodynia: State of the ...

In a retrospective chart review of estradiol/testosterone cream for premenopausal women with PV, vulvar pain was reduced pre- to post-treatment.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10107324/

Evaluation and Treatment of Vulvodynia: State of the Science

Ability to have intercourse increased from 36% to 76% posttreatment (P = .002). Daily vulvar pain (VAS 0‐100) reduced from 27.4 to 17.0 (P = .004). Dyspareunia ...

7.

researchgate.net

researchgate.net/publication/323233339_Hormonal_metabolic_and_endometrial_safety_of_testosterone_vaginal_cream_versus_estrogens_for_the_treatment_of_vulvovaginal_atrophy_in_postmenopausal_women_A_randomized_placebo-controlled_study

A randomized, placebo-controlled study | Request PDF

Results: After 12 weeks of treatment, there were no significant differences in hormonal or metabolic laboratory values among all three groups.

8.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/29462095/

a randomized, placebo-controlled study

No change in endometrial thickening was reported in all three groups. Conclusions: Twelve weeks of treatment with topical testosterone or estrogen in ...

9.

ohsu.edu

ohsu.edu/sites/default/files/2019-09/CPD%20AMH919-Adams%20handouts.pdf

Safety and efficacy of testosterone for women

Data are insufficient to draw conclusions about the effects of testosterone on musculoskeletal, cognitive, and mental health and long-term safety and use in ...