Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04534881
Other study ID # 31144
Secondary ID
Status Terminated
Phase Phase 2
First received
Last updated
Start date October 20, 2020
Est. completion date January 18, 2023

Study information

Verified date February 2024
Source St. Louis University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

The number of individuals with gender incongruence who present to their physician for hormone therapy has increased manifold in the last decade. Testosterone therapy in transgender men (also known as female-to-male transgender or transmen) and estrogen therapy in transgender women (also known as male-to-female transgender or transwomen) respectively is the mainstay of hormone regimen.Transwomen, who are genetically men, receive estradiol replacement with the aim of suppressing serum testosterone and achieving serum estradiol concentrations that mimic the serum concentrations of biological women. This leads to an increase in fat mass, breast growth and decreases in lean mass and masculine pattern hair. However, the results of these changes are often less than satisfactory and additional therapy is required. Breast development is a major concern for transgender females. There is a great deal of variability among individuals, as evidenced during pubertal development.Transgender women do not achieve the same level of breast development as cisgender women do after puberty. Typically, transgender women plateau at Tanner stage III and half of the transgender women have a AAA cup size or less.Investigators plan to conduct a randomized, placebo controlled double blind study evaluating the effect of adding progesterone for 6 months to transwomen who are being treated with estradiol. The hypothesis is that progesterone will decrease serum testosterone concentrations as compared to placebo and increase breast size. Investigators will also assess its role in mood, sleep, scalp hair and androgenic hair growth.


Recruitment information / eligibility

Status Terminated
Enrollment 5
Est. completion date January 18, 2023
Est. primary completion date January 18, 2023
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 65 Years
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Saint Louis University Saint Louis Missouri

Sponsors (1)

Lead Sponsor Collaborator
St. Louis University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
See also
  Status Clinical Trial Phase
Completed NCT04036500 - Transgender Estradiol Early Phase 1
Recruiting NCT05469204 - Effect of Estrogen Treatment on Drug Metabolism and Transport
Not yet recruiting NCT05337865 - Transgender Observational Performance
Completed NCT04448418 - The Impact of COVID-19 Outbreak on Trans-population's Health in Italy
Active, not recruiting NCT05116293 - Effect of Testosterone Treatment on Drug Metabolism and Transport
Recruiting NCT05166083 - Investigation of the Perceptual and Acoustic Voice in Trans Man
Not yet recruiting NCT05927350 - Research Participation With Transgender and Gender-Diverse Youth
Recruiting NCT04515472 - Effect of Gender Affirming Hormone Therapy on Glucose Metabolism Early Phase 1
Not yet recruiting NCT06177600 - TransHealthGUIDE: Transforming Health for Gender-Diverse Youth N/A
Completed NCT03864913 - Comparing Subcutaneous Testosterone to Intramuscular Testosterone in Gender Affirming Care of Transgender Male Adolescents Early Phase 1
Recruiting NCT05924217 - Gynecology Beyond Gender: Cervical Cancer Screening in Transgender Men in France
Completed NCT05187442 - The Experiences of Erotic and Sexual Risk of Transgender Men: Exploratory Research Design
Completed NCT03120936 - The Stay Study: A Demonstration Project Advancing PrEP Delivery in the San Francisco Bay Area Transgender Community Phase 4
Recruiting NCT04478760 - Trans & Non-binary Reference Intervals While on Hormone Therapy Study