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New treatment option for Postoperative Bleeding
Official title Topical Estrogen: Brief Intervention to Improve Postoperative Experience for Transgender Men Undergoing Hysterectomy
ClinicalTrials.gov ID: NCT06969326
What this study is testing
What is Use of topical estradiol?
Use of topical estradiol is an investigational medicine, given as a treatment applied to the skin, being studied as a potential treatment for postoperative bleeding.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- 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 assigned by chance to the...
- Have stable physical and mental health
- No contraindications to estrogen therapy
You likely can't join if
- Under age 18
- Have not been on testosterone for at least 6 months prior to planned hysterectomy
- Known allergy to topical estrogen
See the full eligibility 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 assigned by chance 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
- Under age 18
- Have not been on testosterone for at least 6 months prior to planned hysterectomy
- Known allergy to topical estrogen
The study team makes the final eligibility decision.
Where it's taking place
- Providence, Rhode Island, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Providence, Rhode Island, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.