Status:
RECRUITING
Topical Estrogen: Brief Intervention to Improve Postoperative Experience for Transgender Men Undergoing Hysterectomy
Lead Sponsor:
Women and Infants Hospital of Rhode Island
Conditions:
Postoperative Bleeding
Gender Dysphoria
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
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 postoper...
Detailed Description
OBJECTIVES, SPECIFIC AIMS, BACKGROUND Vaginal bleeding causes significant dysphoria in many transgender men. The goal of hysterectomy for many patients is to eliminate the risk of bleeding, but the in...
Eligibility Criteria
Inclusion
- Gender diverse/transgender men
- Age 18 or older
- 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.
- Have stable physical and mental health
- No contraindications to estrogen therapy
- Must be proficient in English or Spanish
- Must have access to a device to receive text messages for study follow up
- Must agree to allow their medical data to be used for research purposes
Exclusion
- Under age 18
- Have not been on testosterone for at least 6 months prior to planned hysterectomy
- Known allergy to topical estrogen
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT06969326
Start Date
May 1 2025
End Date
December 1 2026
Last Update
May 13 2025
Active Locations (1)
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1
Women & Infants Hospital
Providence, Rhode Island, United States, 02905