NCT07407647RecruitingPhase 2
Vaginal DHEA to Improve Vaginal Health After Radiation for Women With Gynecologic, Anal or Rectal Cancer
Vaginal DHEA for Women With Gynecologic and Gastrointestinal Cancer After Radiation
Source: ClinicalTrials.gov · Last updated 21 Apr 2026
Brief summary (registry, in English)
This phase II trial tests the feasibility and side effects of vaginal DHEA to improve vaginal health after radiation for women with gynecologic, anal or rectal cancer. Treatment of cancers with radiation to the abdomen can influence the vaginal microbiome (any bacteria, virus, or other organisms found in the vagina). Both menopause and radiation cause a decrease in lubrication and elasticity of the vagina and symptoms including vaginal dryness, vaginal burning and itching, vaginal bleeding, pain or burning during urination, and pain during sexual intercourse. DHEA is a type of hormone replacement therapy. It is use to improve symptoms in women during menopause and may be effective in treating these symptoms for women who have received radiation.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 25 (estimated)
- First submitted
- 14 Jan 2026
- Start date
- 12 Mar 2026
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Ohio State University Comprehensive Cancer Center
- Diseases
- Cervical cancer, Colorectal cancer
- NCT number
- NCT07407647
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 25
- From 12 Mar 2026 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who have received prior pelvic radiation
- 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
- Patients receiving palliative radiation therapy
Other illness
- Patients with scleroderma, mixed connective tissue disorder, and lupus will be excluded
- Undiagnosed abnormal genital bleeding (unrelated to current diagnosis or treatment related toxicity)
- Endometrial cancer or endometrial hyperplasia
- History of breast cancer
Other
- Patients who do not meet criteria for menopause
Who the study is looking for
- 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
Age in the registry: 50 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ohio State University Comprehensive Cancer Center Coordinator of this site? Confirm its status | Columbus | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.