Health TrialsbyHealthPanel

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

ConditionsVulvodyniaDyspareuniaLichen Sclerosus of Vulva
Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexFemale
Age18+
SponsorTriHealth Inc.

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18 years or older

Patients with vulvodynia who present with pain (with vaginal penetration) rating score of 4 or greater

Disqualifiers

Active vaginal infection

Pregnancy

Breast-feeding

Taking anti-androgenic medication (finasteride, dutasteride)

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

44 Participants
are divided into 2 treatment groups
Group A: Standard of careActive comparator 1 intervention
Group B: TreatmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Typical pain with vaginal penetration within last 2 weeks

Typical pain with vaginal penetration within last 2 weeks using numeric rating scale

Time frame
at 12 weeks post-treatment

Secondary outcomes

1

Typical pain with vaginal penetration within last 2 weeks

Typical pain with vaginal penetration within last 2 weeks using numeric rating scale

Time frame
at 6 weeks post-treatment
2

Sexual function

sexual function as measured by Female Sexual Function Index

Time frame
at 6 weeks and 12 weeks post-treatment
3

Most intense pain with vaginal penetration within last 2 weeks

Most intense pain with vaginal penetration within last 2 weeks using numeric rating scale

Time frame
at 6 weeks and 12 weeks post-treatment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

TriHealth Inc.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: