drugset / Trial / NCT06969326
Topical Estrogen: Brief Intervention to Improve Postoperative Experience for Transgender Men Undergoing Hysterectomy
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2025-05-01
- Primary completion
- 2026-09-01
- Completion
- 2026-12-01
Publications
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Estradiol | Other / unclassified | 2 g | Topical |
Indications
No indication recorded.