Use of Topical Testosterone and Estrogen vs Estrogen Alone in Vulvodynia: a Randomized Controlled Trial

Part of paid clinical trials in Cincinnati, Ohio.

Sponsor
TriHealth Inc.
Study ID
NCT07260825
Phase
PHASE2/PHASE3
Status
Not Yet Recruiting

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Conditions

  • Dyspareunia
  • Lichen Sclerosus of Vulva
  • Vulvodynia

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Estradiol 0.01% Vag Cream — DRUG
    0.01% Estradiol cream, 1g to be applied to the vestibule twice daily for 12 weeks
  • testosterone 0.1% and estradiol 0.01% vaginal cream — DRUG
    0.01% Estradiol and 0.1% testosterone cream, apply 1g to the vestibule twice daily for 12 weeks

Study Details

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.

Key Dates

Start date
Dec 31, 2025
Status verified
Nov 2025
Primary completion
Jul 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
44 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Standard of care
    Patients receiving standard of care
  • Experimental: Treatment
    Patients receiving study treatment

Primary Outcome Measure

Typical pain with vaginal penetration within last 2 weeks [ Time Frame: at 12 weeks post-treatment ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Cincinnati Urogynecology AssociatesCincinnatiOhio45220
Jennifer Hodge, RN
[email protected]
513-463-4300
TriHealthCincinnatiOhio45220-

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Cincinnati Urogynecology Associates· Cincinnati, OHTriHealth· Cincinnati, OH

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