Progesterone for Transgender Women

Overseen By Kayla Tanya Patel, MD

Age: 18 - 65

Sex: Male

Trial Phase: Phase 2

Sponsor: Emory University

Must be taking: Gender-affirming hormones

Must not be taking: ACE inhibitors, Statins, Antipsychotics, others

Disqualifiers: Liver disease, Kidney disease, Heart failure, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 6 months

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effects of oral progesterone on transgender women, focusing on reducing psychological distress, improving sleep quality, and enhancing overall quality of life. Researchers also examine changes in breast size, feelings of gender congruence, and potential impacts on heart health. Participants will receive either a placebo or progesterone alongside their existing hormone therapy. Suitable candidates are transgender women who have been on gender-affirming hormone therapy for at least six months and do not have conditions like liver disease or a history of blood clots. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to significant advancements in transgender health care.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using certain medications like ACE inhibitors, statins, or certain antidepressants. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Previous studies have found that transgender women generally tolerate progesterone well. No major reports have indicated negative effects on sleep, mental health, or breast development from low-dose micronized progesterone. Some research even suggests it might help protect against the rare risk of breast cancer in transgender women. Overall, these findings indicate that progesterone is relatively safe to use in this context. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Progesterone is unique for transgender women because it adds a new dimension to existing gender-affirming hormone therapies. Unlike standard treatments, which often focus solely on estradiol and anti-androgens, progesterone could offer additional benefits such as improved breast development and potentially better mood stabilization. Researchers are excited about progesterone because it may complement existing therapies by enhancing physical changes and overall well-being, providing a more comprehensive approach to gender transition.

What evidence suggests that progesterone might be an effective treatment for psychological distress in transgender women?

This trial will compare the effects of progesterone with a placebo in transgender women. Research has shown that many transgender women using progesterone experience improved breast development and an enhanced sense of femininity. Some studies have found that adding progesterone to hormone therapy can increase satisfaction with breast growth. However, other research has found no significant changes in sleep quality, mental health, or breast development with low-dose progesterone. While progesterone may assist with certain aspects of gender transition, its effects can vary among individuals. ^{1 2 3 5 6}

Who Is on the Research Team?

Vin Tangpricha, MD, PhD

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

This trial is for transgender women who are interested in the potential benefits of progesterone on psychological well-being, sleep, breast development, quality of life, and cardiovascular health.

Inclusion Criteria

I am a transgender woman and have been on hormone therapy for at least 6 months.

Exclusion Criteria

Peanut allergy

Non-English speaking or those with limited English proficiency

I have been diagnosed with congestive heart failure.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive either a placebo or 200 mg oral micronized progesterone at bedtime in addition to their existing gender-affirming therapy

6 months

Monthly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Progesterone

Trial Overview The study tests Oral Progesterone against a placebo to see if it helps reduce psychological distress and improves sleep quality, breast size, overall quality of life and gender congruence without increasing cardiovascular risk.

How Is the Trial Designed?

Group I: Group B Experimental Treatment 1 Intervention

Group B will serve as our intervention group with participants on their existing gender-affirming therapy in combination with 200 mg oral micronized progesterone at bedtime. Laboratory assessments including estradiol, lipid profile, and Complete metabolic profile (CMP) will be performed at screening.

Group II: Group A Placebo Group 1 Intervention

Group A will serve as our control group with participants on their existing gender-affirming therapy in addition to a placebo pill. Laboratory assessments including estradiol, lipid profile, and Complete metabolic profile (CMP) will be performed at screening.

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S1530891X25009437

Progestogen Experience Among Transgender Women and ... Most progestogen users perceive subjective improvement in breast development, sense of femininity, and mood, but fewer report impact on libido, sleep, or ...

2. academic.oup.com academic.oup.com/jcem/article/104/4/1181/5270376

Progesterone Is Important for Transgender Women's Therapy ... The combined evidence suggested that progesterone would protect against the rare risk of breast cancer in transgender women treated with E. Conclusion. Oral ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11594581/

The Potential Health Risks and Benefits of Progesterone in the ... Transgender women who underwent progesterone-enhanced feminizing hormone therapy reported increased satisfaction with their breast development at six and nine ...

4. ec.bioscientifica.com ec.bioscientifica.com/view/journals/ec/11/5/EC-22-0170.xml

Effects of low-dose oral micronised progesterone on sleep ... Low-dose progesterone was not associated with changes in sleep quality, psychological distress, or breast development over 3 months follow-up.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06807580

Progesterone in Gender Affirming Hormone Therapy Study A recent study on low-dose micronized progesterone found no significant effects on sleep quality, psychological distress, or breast development.

6. japha.org japha.org/article/S1544-3191(23)00252-2/fulltext

Effects of progesterone on gender affirmation outcomes as ... This study aimed to provide quantifiable outcomes data regarding the use of progesterone in transgender women. Methods. This retrospective ...