NCT06969326 · Women and Infants Hospital of Rhode Island
Topical Estrogen: Brief Intervention to Improve Postoperative Experience for Transgender Men Undergoing Hysterectomy
What this study is about
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).
View original scientific description
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.
Interventions
DRUG
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.
OTHER
No intervention
This arm will not receive estradiol or other cream
Primary outcome measures
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
The investigators hypothesize that administration of postoperative estrogen cream vaginally in the operating room will decrease the need for health system contact for bleeding in the initial postoperative period. Patients will be asked to complete a brief email survey on postoperative days: 1, 3, 7, \& 14 as well as at final postoperative visit \~42 days. This survey will target multiple things Outcome 1: Quantity of bleeding Determined by patient report: 1) small amount of spotting with wiping; 2) Staining pad, changing every 3-4 hours; 3) Bleeding like a light period; 4) Passing clots/heavy bleeding Additionally, chart review will be completed to assess for ED visits, office phone calls, MyChart Messages and any after-hours pages will be recorded.
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
The investigators hypothesize that this intervention will demonstrate improved patient bleeding and dysphoria symptoms during the postoperative recovery period. The investigators will also measure mental health impact. Pre and postoperative Vanderbilt Mini Patient-Reported Outcome Measure - Gender (VMP-G)) scores will be obtained. This is a validated tool that assesses gender identity and gender affirming procedures as well as quality of life, self-concept, satisfaction, and gender dysphoria. (Hung 2023).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- Under age 18
- Have not been on testosterone for at least 6 months prior to planned hysterectomy
- Known allergy to topical estrogen
Where
- Providence, Rhode Island
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 13, 2025 · Source of record for eligibility and locations