Effect of Progesterone on Testosterone Concentrations and Breast Development in Transwomen

• Status: Recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St. Louis University
• Treatments: Progesterone

Criteria

Inclusion Criteria:

• Transwomen, currently on treatment with estradiol therapy for at least 6 months (as their standard of care gender affirming therapy)

• Has achieved serum estradiol >100 pg/ml at least once, based on clinical labs in past.

Exclusion Criteria:

1. Treatment with progesterone in the last 2 months

2. HIV

3. Planning to go for breast enhancement or gender reassignment surgery in the next 6 months

4. Known history of peanut allergy (because the study drug contains peanut oil)

5. Active deep vein thrombosis, pulmonary embolism or history of these conditions

6. Active arterial thromboembolic disease or history of these conditions

7. Active cardiovascular disorders or history of these conditions (e.g. myocardial infarction, uncontrolled hypertension >150/90 mmHg)

8. Known, suspected, or history of breast cancer

9. Known liver dysfunction or disease

10. Known or history of gallbladder disease. This does not apply to subjects who have undergone cholecystectomy

11. Known or history of hypertriglyceridemia (>400 mg/dl)