NCT04534881

Effect of Progesterone on Testosterone Concentrations and Breast Development in Transwomen

Terminated Phase 2 Results posted Last updated 19 March 2024

What this trial tests

Phase 2 trial testing Progesterone 200 MG in Transgender Persons in 5 participants. Terminated before completion.

Timeline

20 October 2020

Primary endpoint
18 January 2023

18 January 2023

Quick facts

Lead sponsor	St. Louis University
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	5
Start date	20 October 2020
Primary completion	18 January 2023
Estimated completion	18 January 2023
Sites	1 location across United States

Drugs / interventions tested

• Progesterone 200 MG — full drug profile →
• Placebo

Conditions studied

• Transgender Persons — all drugs for Transgender Persons →

Sponsor

St. Louis University

Who can join

Adults 18 to 65, male only, with Transgender Persons. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Efficacy: Testosterone Primary · 24 weeks

Change from baseline till 24 weeks in serum testosterone concentrations between progesterone and placebo groups. Calculated as testosterone levels at 24 weeks minus baseline

Group	Value	95% CI
Progesterone	1.5	± 4
Placebo	-6.4	± 0

Sponsor's own description

* 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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.