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.

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

What You Need to Know Before You Apply

What is the purpose of this trial?

We are looking to see if patients using both topical testosterone and estrogen will have a greater improvement in pain with vaginal penetration compared to those using topical estrogen alone.

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.

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+