Topical Estrogen for Transgender Men Undergoing Hysterectomy

Overseen By Beth Cronin, MD

Age: 18+

Sex: Female

Trial Phase: Phase 3

Sponsor: Women and Infants Hospital of Rhode Island

Must be taking: Testosterone

Disqualifiers: Under 18, Estrogen allergy, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 43

Duration: Immediate (single application)

48 Participants Needed

Trial Summary

What is the purpose of this trial?

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

This trial is for transgender men who are undergoing a hysterectomy and may be concerned about postoperative bleeding or experiencing gender dysphoria. Participants should not have used any hormonal treatments recently.

Inclusion Criteria

Must agree to allow their medical data to be used for research purposes

I have been on testosterone for 6+ months and am planning a gender-affirming hysterectomy with potential post-surgery estrogen use.

Must have access to a device to receive text messages for study follow up

Exclusion Criteria

Known allergy to topical estrogen

I am under 18 years old.

I haven't taken testosterone for 6 months before my planned hysterectomy.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Application of topical estradiol at the conclusion of surgery to improve postoperative experience

Immediate (single application)

Postoperative Monitoring

Participants are monitored for postoperative bleeding and dysphoria symptoms

2 weeks

Postoperative days: 1, 3, 7, 14

Follow-up

Participants are monitored for safety and effectiveness after treatment, including quality of life measures

6 weeks

Final postoperative visit at ~42 days

Treatment Details

Interventions

• Topical Estrogen

Trial Overview The study is testing if applying topical estrogen cream right after a hysterectomy can reduce bleeding and discomfort related to gender dysphoria. It's comparing patients who get the cream with those who don't, to see if it should be standard care.

Participant Groups

Group I: Estradiol Experimental Treatment 1 Intervention

Application of topical estradiol at conclusion of surgery

Group II: Placebo Placebo Group 1 Intervention

Standard surgical treatment will be provided

Who Is Running the Clinical Trial?

Women and Infants Hospital of Rhode Island

Lead Sponsor

Trials

119

Recruited

59,200+