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

NCT06969326 | Recruiting Phase 3 FDA Drug

• 1 other identifier: 2255554-1
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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

Keywords

gender dysphoria; gender affirmation; hysterectomy

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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.

  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).

  6 weeks

Other Outcomes (1)

• 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.

  2 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Standard surgical treatment will be provided

Other: No intervention

Estradiol

EXPERIMENTAL

Application of topical estradiol at conclusion of surgery

Drug: Use of topical estradiol

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.

Estradiol

No intervention OTHER

This arm will not receive estradiol or other cream

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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

You may not qualify if:

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

Sponsors & Collaborators

• Women and Infants Hospital of Rhode Island: lead

Study Sites (1)

Women & Infants Hospital

Providence, Rhode Island, 02905, United States

RECRUITING

Related Publications (8)

• Schwartz BI, Effron A, Bear B, Short VL, Eisenberg J, Felleman S, Kazak AE. Experiences with Menses in Transgender and Gender Nonbinary Adolescents. J Pediatr Adolesc Gynecol. 2022 Aug;35(4):450-456. doi: 10.1016/j.jpag.2022.01.015. Epub 2022 Feb 3.

  PMID: 35123055 BACKGROUND

• Rahn DD, Richter HE, Sung VW, Pruszynski JE, Hynan LS. Perioperative Vaginal Estrogen as Adjunct to Native Tissue Vaginal Apical Prolapse Repair: A Randomized Clinical Trial. JAMA. 2023 Aug 15;330(7):615-625. doi: 10.1001/jama.2023.12317.

  PMID: 37581673 BACKGROUND

• Rahn DD, Good MM, Roshanravan SM, Shi H, Schaffer JI, Singh RJ, Word RA. Effects of preoperative local estrogen in postmenopausal women with prolapse: a randomized trial. J Clin Endocrinol Metab. 2014 Oct;99(10):3728-36. doi: 10.1210/jc.2014-1216. Epub 2014 Jun 20.

  PMID: 24947034 BACKGROUND

• Pando C, Gerlach LR, Challa SA, Pan AY, Francis J. Operative Complications, Vaginal Bleeding, and Practice Considerations for Patients on Testosterone Undergoing Gender-Affirming Hysterectomy. J Minim Invasive Gynecol. 2024 Oct;31(10):836-842. doi: 10.1016/j.jmig.2024.05.026. Epub 2024 May 31.

  PMID: 38823625 BACKGROUND

• Khalifa MA, Toyama A, Klein ME, Santiago V. Histologic Features of Hysterectomy Specimens From Female-Male Transgender Individuals. Int J Gynecol Pathol. 2019 Nov;38(6):520-527. doi: 10.1097/PGP.0000000000000548.

  PMID: 30252728 BACKGROUND

• Karp DR, Jean-Michel M, Johnston Y, Suciu G, Aguilar VC, Davila GW. A randomized clinical trial of the impact of local estrogen on postoperative tissue quality after vaginal reconstructive surgery. Female Pelvic Med Reconstr Surg. 2012 Jul-Aug;18(4):211-5. doi: 10.1097/SPV.0b013e31825e6401.

  PMID: 22777369 BACKGROUND

• Hung YC, Park BC, Assi PE, Perdikis G, Drolet BC, Kassis SA. Multidimensional Assessment of Patient-Reported Outcomes After Gender-Affirming Surgeries Using a Validated Instrument. Ann Plast Surg. 2023 Nov 1;91(5):604-608. doi: 10.1097/SAP.0000000000003652. Epub 2023 Aug 12.

  PMID: 37553914 BACKGROUND

• Cipres DT, Shim JY, Grimstad FW. Postoperative Vaginal Bleeding Concerns after Gender-Affirming Hysterectomy in Transgender Adolescents and Young Adults on Testosterone. J Pediatr Adolesc Gynecol. 2023 Feb;36(1):33-38. doi: 10.1016/j.jpag.2022.09.002. Epub 2022 Sep 8.

  PMID: 36089115 BACKGROUND

MeSH Terms

Conditions

Postoperative Hemorrhage; Gender Dysphoria

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Sexual Dysfunctions, Psychological; Mental Disorders

Central Study Contacts

Beth Cronin, MD

CONTACT

401-274-1122; bcronin@wihri.org

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Division Director, Division of General Obstetrics and Gynecology

Study Record Dates

• First Submitted: February 10, 2025
• First Posted: May 13, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 13, 2025

Record last verified: 2025-05

Locations

US (1)