VulvodyniaPhase 2/3NCT07260825
Use of Topical Testosterone and Estrogen vs Estrogen Alone in Vulvodynia: a Randomized Controlled Trial
A Phase 2/3 study testing Estradiol 0.01% Vag Cream and testosterone 0.1% and estradiol 0.01% vaginal cream in people with Vulvodynia and Dyspareunia, run by TriHealth Inc. at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Vulvodynia, Dyspareunia, Lichen Sclerosus of Vulva
- What is being tested?
- Estradiol 0.01% Vag Cream and testosterone 0.1% and estradiol 0.01% vaginal cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2025to Aug 2026
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- Patients with vulvodynia who present with pain (with vaginal penetration) rating score of 4 or greater
Who cannot join
- Active vaginal infection
- Pregnancy
- Breast-feeding
- Taking anti-androgenic medication (finasteride, dutasteride)
- Using any other topical hormones to the vulva or vagina
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Cincinnati Urogynecology Associates
Cincinnati, Ohio, 45220
Jennifer Hodge, RN, 513-463-4300, Jennifer_hodge2@trihealth.com
TriHealth
Cincinnati, Ohio, 45220
About this study
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.
Read the detailed description
You are being asked to take part in this research study because you have vulvodynia. Vulvodynia refers to pain in the female vestibule. The vestibule is the area that encircles the vaginal opening and the urethra opening. One of the symptoms of vulvodynia is pain with intercourse.
The purpose of this research study is to determine if using estrogen cream versus a combined cream with estrogen and testosterone helps decrease your pain with intercourse.
Multiple studies have been conducted looking at the use of combined cream with estrogen and testosterone to treat vulvodynia. However, none of the studies have compared this to using estrogen cream alone. It is well known that estrogen cream applied to the vagina helps reduce symptoms of vulvodynia. Combined creams with estrogen and testosterone have been shown to help patients who have vulvodynia and are taking birth control pills.
In 2016, the FDA approved a vaginal cream, known as DHEA, to help women with painful intercourse. This is a substance that once applied to the vagina, turns into a mixture of estrogen and testosterone. We know from prior research that the vestibule area is rich in testosterone receptors, so it makes sense that DHEA cream applied vaginally would be able to help vulvodynia patients. However, we do not know the ratio of the breakdown of estrogen versus testosterone from the DHEA substance.
Testosterone applied to the vagina has been shown to improve symptoms in patients with other vulvar conditions, such as lichen sclerosus. Lichen sclerosus is a chronic skin condition that primarily affects the genital area, but it can also affect other areas of the body. It is characterized by white, thickened patches of skin that may be itchy, sore, or painful.
Although topical DHEA was FDA approved for use in women with painful intercourse in 2016, topical testosterone combined with estrogen is not FDA approved for use in women, which means it is investigational. However, it is becoming more common as a treatment option for patients with vulvodynia, and its safety and effectiveness in women has been demonstrated in other studies.
- Conditions
- Vulvodynia, Dyspareunia, Lichen Sclerosus of Vulva
- Being tested
- Estradiol 0.01% Vag Cream, testosterone 0.1% and estradiol 0.01% vaginal cream
- Keywords
- topical testosterone, estrogen cream, vulvodynia
- Medical subject headings
- Vulvodynia, Dyspareunia, Vulvar Lichen Sclerosus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Estradiol 0.01% Vag CreamDrug
0.01% Estradiol cream, 1g to be applied to the vestibule twice daily for 12 weeks
testosterone 0.1% and estradiol 0.01% vaginal creamDrug
0.01% Estradiol and 0.1% testosterone cream, apply 1g to the vestibule twice daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Standard of care | Active comparator | Patients receiving standard of care Receives: Drug: Estradiol 0.01% Vag Cream |
| Treatment | Experimental | Patients receiving study treatment Receives: Drug: testosterone 0.1% and estradiol 0.01% vaginal cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Typical pain with vaginal penetration within last 2 weeks
Typical pain with vaginal penetration within last 2 weeks using numeric rating scale
Measured: at 12 weeks post-treatment
Secondary outcomes (3)
Typical pain with vaginal penetration within last 2 weeks
Typical pain with vaginal penetration within last 2 weeks using numeric rating scale
Measured: at 6 weeks post-treatment
Sexual function
sexual function as measured by Female Sexual Function Index
Measured: at 6 weeks and 12 weeks post-treatment
Most intense pain with vaginal penetration within last 2 weeks
Most intense pain with vaginal penetration within last 2 weeks using numeric rating scale
Measured: at 6 weeks and 12 weeks post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2025
- Study startDec 2025 (estimated)
- Primary completionJul 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VulvodyniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TriHealth Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07260825
- Sponsor's protocol ID
- 25-108
- Status last verified
- Nov 2025
- First submitted
- 21 Nov 2025
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Topical Testosterone and Estrogen vs Estrogen Alone in Vulvodynia: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07260825
- Acronym / sponsor ID
- 25-108
- Conditions
- Vulvodynia, Dyspareunia, Lichen Sclerosus of Vulva
- Keywords
- topical testosterone, estrogen cream, vulvodynia
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- TriHealth Inc.University, hospital or other
- Study start
- Dec 2025 (estimated)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 3 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
You are being asked to take part in this research study because you have vulvodynia. Vulvodynia refers to pain in the female vestibule. The vestibule is the area that encircles the vaginal opening and the urethra opening. One of the symptoms of vulvodynia is pain with intercourse.
The purpose of this research study is to determine if using estrogen cream versus a combined cream with estrogen and testosterone helps decrease your pain with intercourse.
Multiple studies have been conducted looking at the use of combined cream with estrogen and testosterone to treat vulvodynia. However, none of the studies have compared this to using estrogen cream alone. It is well known that estrogen cream applied to the vagina helps reduce symptoms of vulvodynia. Combined creams with estrogen and testosterone have been shown to help patients who have vulvodynia and are taking birth control pills.
In 2016, the FDA approved a vaginal cream, known as DHEA, to help women with painful intercourse. This is a substance that once applied to the vagina, turns into a mixture of estrogen and testosterone. We know from prior research that the vestibule area is rich in testosterone receptors, so it makes sense that DHEA cream applied vaginally would be able to help vulvodynia patients. However, we do not know the ratio of the breakdown of estrogen versus testosterone from the DHEA substance.
Testosterone applied to the vagina has been shown to improve symptoms in patients with other vulvar conditions, such as lichen sclerosus. Lichen sclerosus is a chronic skin condition that primarily affects the genital area, but it can also affect other areas of the body. It is characterized by white, thickened patches of skin that may be itchy, sore, or painful.
Although topical DHEA was FDA approved for use in women with painful intercourse in 2016, topical testosterone combined with estrogen is not FDA approved for use in women, which means it is investigational. However, it is becoming more common as a treatment option for patients with vulvodynia, and its safety and effectiveness in women has been demonstrated in other studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of care | Active comparator | Drug: Estradiol 0.01% Vag CreamPatients receiving standard of care |
| Treatment | Experimental | Drug: testosterone 0.1% and estradiol 0.01% vaginal creamPatients receiving study treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years or older
- Patients with vulvodynia who present with pain (with vaginal penetration) rating score of 4 or greater
Key exclusion criteria (5 listed)
- Active vaginal infection
- Pregnancy
- Breast-feeding
- Taking anti-androgenic medication (finasteride, dutasteride)
- Using any other topical hormones to the vulva or vagina
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Estradiol 0.01% Vag Cream0.01% Estradiol cream, 1g to be applied to the vestibule twice daily for 12 weeks | Drug | Standard of care |
| testosterone 0.1% and estradiol 0.01% vaginal cream0.01% Estradiol and 0.1% testosterone cream, apply 1g to the vestibule twice daily for 12 weeks | Drug | Treatment |
Primary outcome
Typical pain with vaginal penetration within last 2 weeks
Time frame: at 12 weeks post-treatment
Typical pain with vaginal penetration within last 2 weeks using numeric rating scale
3 secondary outcomes
Typical pain with vaginal penetration within last 2 weeks
Time frame: at 6 weeks post-treatment
Sexual function
Time frame: at 6 weeks and 12 weeks post-treatment
Most intense pain with vaginal penetration within last 2 weeks
Time frame: at 6 weeks and 12 weeks post-treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
Related trials for Vulvodynia
Active, not recruitingPhase 2
A Phase 2 Study to Evaluate the Efficacy and Safety of Pudafensine in Vulvodynia (Provoked Vestibulodynia)
Vulvodynia
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Integrated Care Pathway for Hormonally Mediated Vestibulodynia: a Feasibility and Acceptability Pilot
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Active, not recruiting
Vestibulectomy Surgical Techniques Comparison Study
Vulvar Pain, Vulvodynia
Not yet recruiting
Transcutaneous Genital Nerves Stimulation for the Treatment of Refractory Chronic Pelvic and Genital Pain in Women.
Refractory Visceral Pelvic Pain, Refractory Genital Pain
Not yet recruitingPhase 2
A Pilot Study on the Efficacy of Oral Low Dose Naltrexone for Vulvodynia
Vulvodynia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Estradiol 0.01% Vag Cream and testosterone 0.1% and estradiol 0.01% vaginal cream in people with Vulvodynia and Dyspareunia, run by TriHealth Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gisele Moran, MD, MPH (513-463-4300, gisele_moran@trihealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Typical pain with vaginal penetration within last 2 weeks (time frame: at 12 weeks post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2025.