Effect of Progesterone on Testosterone Concentrations and Breast Development in Transwomen

NCT04534881 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: 31144
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Transgender Persons

Keywords

Testosterone, breast

Outcome Measures

Primary Outcomes (1)

• Efficacy: Testosterone

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

  24 weeks

Study Arms (2)

progesterone

ACTIVE COMPARATOR

subjects on active drug (progesterone)

Drug: Progesterone 200 MG

placebo

PLACEBO COMPARATOR

subjects on placebo

Drug: Placebo

Interventions

Progesterone 200 MG DRUG

Subjects will be randomized to receive generic micronized progesterone 200 mg or placebo tablets, to be taken at bedtime daily.

progesterone

Placebo DRUG

Subjects will be randomized to receive generic micronized progesterone 200 mg or placebo tablets, to be taken at bedtime daily.

placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Transwomen
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Treatment with progesterone in the last 2 months
• HIV
• Planning to go for breast enhancement or gender reassignment surgery in the next 6 months
• Known history of peanut allergy (because the study drug contains peanut oil)
• Active deep vein thrombosis, pulmonary embolism or history of these conditions
• Active arterial thromboembolic disease or history of these conditions
• Active cardiovascular disorders or history of these conditions (e.g. myocardial infarction, uncontrolled hypertension \>150/90 mmHg)
• Known, suspected, or history of breast cancer
• Known liver dysfunction or disease
• Known or history of gallbladder disease. This does not apply to subjects who have undergone cholecystectomy
• Known or history of hypertriglyceridemia (\>400 mg/dl)

Sponsors & Collaborators

• St. Louis University: lead

Study Sites (1)

Saint Louis University

St Louis, Missouri, 63141, United States

Location

MeSH Terms

Interventions

Progesterone

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Corpus Luteum Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progesterone Congeners; Gonadal Steroid Hormones

Results Point of Contact

• Title: Sandeep Dhindsa
• Organization: Saint Louis University

sandeep.dhindsa@health.slu.edu

13149774911

Study Officials

• Sandeep Singh Dhindsa Dhindsa, MD

  St. Louis University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: August 17, 2020
• First Posted: September 1, 2020
• Study Start: October 20, 2020
• Primary Completion: January 18, 2023
• Study Completion: January 18, 2023
• Last Updated: March 19, 2024
• Results First Posted: March 19, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)