drugset / Trial / NCT04534881

Effect of Progesterone on Testosterone Concentrations and Breast Development in Transwomen

NCT04534881

Phase 2 Terminated 5 enrolled St. Louis University
RandomizedParallel-groupTriple-blindTreatment

Summary

* Purpose. The purpose of this research is study the effect of progesterone therapy on testosterone levels in transwomen who are currently on gender affirming treatment with estradiol. * Duration. It is expected that participation will last for 6 months (24 weeks). * Study Procedures. Participants will be asked to sign an informed consent, complete a medical history, have a physical exam conducted, have a fasting blood sample taken and asked to take a study drug once daily. * Risks. Some of the foreseeable risks or discomforts include temporary discomfort, bleeding, bruising and/or swelling in the arm from blood draw. There are no known direct risks with the use of Progesterone in Transwomen for gender affirming therapy. * Benefits. Some of the possible benefits that may be expected include increase in fat mass, increase in breast size/fullness, decrease in masculine hair patterns.

Timeline

Start
2020-10-20
Primary completion
2023-01-18
Completion
2023-01-18

Drugs

EvaluationDrugModalityDoseRoute
Comparator Progesterone Other / unclassified 200 mg

Indications

No indication recorded.