Could a hormone cream ease Post-Radiation vaginal pain? new trial investigates
NCT ID NCT07407647
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 trial tests whether a vaginal DHEA suppository can safely improve vaginal health in 25 women who had radiation for gynecologic, anal, or rectal cancer. Radiation often causes dryness, burning, and pain, similar to menopause. DHEA is a hormone replacement that may help. The study checks for side effects and changes in the vaginal microbiome.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Prasterone (DHEA) vaginal suppository
- What this could lead to
- If it works, this could offer a hormone-based option to relieve vaginal discomfort and improve quality of life for women after pelvic radiation.
- What could go wrong
- This is a small early-phase trial with only 25 participants, so results may not apply to everyone. DHEA can cause side effects like vaginal discharge or irritation.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 25 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2026
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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50 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Any patient with anal, rectal, cervical, vaginal, or vulvar cancer receiving external beam radiation alone, or both external beam radiation and brachytherapy with curative intent (Participants will be consented and enrolled prior to starting treatment but will not receive intervention till after treatment is completed) * Concurrent or prior chemotherapy is allowed * Any prior gynecologic surgery is permitted * Rectal surgery, including lower anterior resection and abdominoperineal resection, is permitted * Subject must be menopausal, which is defined as age \> 50 with no menses for 12 months or bilateral oophorectomy Exclusion Criteria: * Patients with scleroderma, mixed connective tissue disorder, and lupus will be excluded * Patients who have received prior pelvic radiation * Undiagnosed abnormal genital bleeding (unrelated to current diagnosis or treatment related toxicity) * Endometrial cancer or endometrial hyperplasia * Use of estrogen alone injectable or progestin implant therapy with 3 months before study entry * Use of estrogen pellet or progestin injectable drug within 6 months before study entry * Use of oral estrogen, progestin, or DHEA or intrauterine progestin within 8 weeks before study entry * Use of vaginal estrogen (rings, creams, tablets, or gels), transdermal estrogen +/- progestin, vaginal hyaluronic acid, or pro-estrogenic herbal treatments such as black cohosh in the 4 weeks before study entry. Intravaginal moisturizers and lubricants prior to enrollment are permitted * History of breast cancer * Patients receiving palliative radiation therapy * Patients who do not meet criteria for menopause
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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Ohio State University Comprehensive Cancer Center
RECRUITINGColumbus, Ohio, 43210, United States
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