NCT06969326 Topical Estrogen: Brief Intervention to Improve Postoperative Experience for Transgender Men Undergoing Hysterectomy
| NCT ID | NCT06969326 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Women and Infants Hospital of Rhode Island |
| Condition | Postoperative Bleeding |
| Study Type | INTERVENTIONAL |
| Enrollment | 48 participants |
| Start Date | 2025-05-01 |
| Primary Completion | 2026-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 48 participants in total. It began in 2025-05-01 with a primary completion date of 2026-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to determine if applying a single dose of topical estrogen cream in the operating room at the end of your hysterectomy (removal of uterus and cervix) improves the postoperative experience with bleeding and potential symptoms of dysphoria (a feeling of discomfort or distress). Topical estrogen cream is sometimes used if patients have increased risk of bleeding with surgery but is not currently utilized in a consistent way. This study aims to answer the question of whether this is a helpful treatment and should be included in standard postoperative care.
Eligibility Criteria
Inclusion Criteria: 1. Gender diverse/transgender men 2. Age 18 or older 3. Have been on testosterone for at least 6 months with plan to undergo gender-affirming hysterectomy and are willing to be randomized to the use of topical estrogen postoperatively. 4. Have stable physical and mental health 5. No contraindications to estrogen therapy 6. Must be proficient in English or Spanish 7. Must have access to a device to receive text messages for study follow up 8. Must agree to allow their medical data to be used for research purposes Exclusion Criteria: 1. Under age 18 2. Have not been on testosterone for at least 6 months prior to planned hysterectomy 3. Known allergy to topical estrogen
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06969326 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Postoperative Bleeding. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06969326 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 48 participants.
Is NCT06969326 currently recruiting?
Yes, NCT06969326 is actively recruiting participants. Contact the research team at bcronin@wihri.org for enrollment information.
Where is the NCT06969326 trial being conducted?
This trial is being conducted at Providence, United States.
Who is sponsoring the NCT06969326 clinical trial?
NCT06969326 is sponsored by Women and Infants Hospital of Rhode Island. The trial plans to enroll 48 participants.