Recruiting
Phase 3

Topical Estrogen

Sponsor:

Women and Infants Hospital of Rhode Island

Code:

NCT06969326

Conditions

Postoperative Bleeding

Gender Dysphoria

Hysterectomy

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Use of topical estradiol

No intervention

Study Details

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.

Conditions

Postoperative Bleeding

Gender Dysphoria

Hysterectomy

Study ID

NCT06969326

Start date

May 1, 2025

Status verified date

May, 2025

Completion date

Dec 1, 2026

Anticipated

Primary completion date

Sep 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

48 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Placebo

Standard surgical treatment will be provided

experimental: Estradiol

Application of topical estradiol at conclusion of surgery

Interventions

Use 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.

No intervention

This arm will not receive estradiol or other cream

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 ]
  • Examine the impact of topical estrogen application on postoperative healing as defined by number of days of bleeding and patient Quality of Life Measures. [ Time Frame: 6 weeks ]

Central Contacts and Locations

Central contacts

Beth Cronin, MD

401-274-1122bcronin@wihri.org

Locations

Women & Infants Hospital

Recruiting

Providence, Rhode Island, United States, 02905

More Information

Sponsor

Women and Infants Hospital of Rhode Island

Last update posted

May 13, 2025

Last verified

May, 2025

Keywords

  • gender dysphoria
  • gender affirmation
  • hysterectomy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Women and Infants Hospital of Rhode Island on 2025-05-13.