RecruitingPhase 3NCT06969326

Topical Estrogen: Brief Intervention to Improve Postoperative Experience for Transgender Men Undergoing Hysterectomy


Sponsor

Women and Infants Hospital of Rhode Island

Enrollment

48 participants

Start Date

May 1, 2025

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria8

  • 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 Criteria3

  • Under age 18
  • Have not been on testosterone for at least 6 months prior to planned hysterectomy
  • Known allergy to topical estrogen

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Interventions

DRUGUse of topical estradiol

The investigators will conduct a double blinded randomized control pilot trial. Participants will be randomized in 1:1 fashion to either receive no treatment or receive 2g of estradiol cream, placed after clearing the vaginal vault of any blood and discharge, at the conclusion of the surgery.

OTHERNo intervention

This arm will not receive estradiol or other cream


Locations(1)

Women & Infants Hospital

Providence, Rhode Island, United States

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NCT06969326


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