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

Part of paid clinical trials in Providence, Rhode Island.

Sponsor
Women and Infants Hospital of Rhode Island
Study ID
NCT06969326
Phase
PHASE3
Status
Recruiting
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Conditions

  • Gender Dysphoria
  • Hysterectomy
  • Postoperative Bleeding

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Use of topical estradiol — DRUG
    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.
  • No intervention — OTHER
    This arm will not receive estradiol or other cream

Study Details

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.

Key Dates

Start date
May 1, 2025
Status verified
May 2025
Primary completion
Sep 1, 2026
Completion
Dec 1, 2026

Study Design

Enrollment
48 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo
    Standard surgical treatment will be provided
  • Experimental: Estradiol
    Application of topical estradiol at conclusion of surgery

Primary Outcome Measure

Evaluate the efficacy of one-time topical estrogen application for reducing postoperative health system contacts for vaginal bleeding in the first two weeks post hysterectomy. [ Time Frame: 2 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Women & Infants HospitalProvidenceRhode Island02905-

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By research site
Women & Infants Hospital· Providence, RI

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