Testosterone for Reproductive Issues

Overseen By Antoni Duleba, MD

Age: 18 - 65

Sex: Female

Trial Phase: Phase 4

Sponsor: University of California, San Diego

Must be taking: Testosterone

Must not be taking: Contraceptives, Androgens, Estrogens, others

Disqualifiers: Pregnancy, Endocrine disease, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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

Compensation: Varies

Number of Visits: 1

Duration: 7 months

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how testosterone affects reproductive hormones in different groups. Researchers aim to determine if testosterone impacts the reproductive systems of transgender men and non-binary individuals beginning hormone therapy. The trial includes two groups: transgender men and non-binary individuals starting testosterone therapy, and cisgender women with regular menstrual cycles. Ideal participants are those planning to start testosterone therapy and have a history of regular menstrual cycles. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, allowing researchers to understand its benefits for more patients.

Will I have to stop taking my current medications?

Yes, you will need to stop taking any medications that affect reproductive hormones, like contraceptives, androgens, estrogens, progestins, and certain diabetes medications.

What is the safety track record for Testosterone Cypionate?

Research has shown that testosterone cypionate is generally safe for transgender men. Studies have found that it aids in masculinizing effects without affecting body weight or blood pressure, indicating good tolerance for those requiring testosterone therapy. Additionally, a review of testosterone use in transgender men reported improved safety and quality of life. The study's later phase indicates that earlier stages confirmed the treatment's safety, further supporting its tolerance in humans. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Testosterone Cypionate is unique because it is specifically used for testosterone replacement therapy in transgender men and non-binary individuals who are beginning their transition. Unlike other hormone therapies, which might use different formulations or delivery methods, Testosterone Cypionate is an injectable form that allows for precise control of hormone levels. Researchers are excited about this treatment as it offers the potential for quicker and more consistent results in aligning secondary sexual characteristics with gender identity. Additionally, its long-acting nature means fewer injections over time, which can be more convenient and less burdensome for patients.

What evidence suggests that Testosterone Cypionate might be an effective treatment for reproductive issues?

Research has shown that testosterone therapy, which participants in this trial may receive, can greatly benefit transgender men by enhancing their quality of life and body functions. Studies have found that testosterone helps change certain body features to align with male characteristics. However, long-term use might not completely stop ovulation in some individuals. The therapy is generally considered safe and effective for those who choose it. Overall, testosterone cypionate is well-known for its success in gender-affirming treatments. ^{1 3 4 6 7}

Who Is on the Research Team?

Antoni Duleba, MD

Principal Investigator

University of California, San Diego

Are You a Good Fit for This Trial?

This trial is for transgender or non-binary individuals aged 18-35 who plan to start testosterone therapy and have had regular menstrual cycles. It's also for cisgender females with regular cycles. Participants must consent to study procedures and be available throughout the study.

Inclusion Criteria

I am transgender/non-binary and starting testosterone.

My menstrual cycle occurs regularly every 24-35 days.

My menstrual cycles were regular, every 24-35 days, before starting treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Baseline measurement of serum LH and other reproductive hormones before initiating TRT

1 week

1 visit (in-person)

Treatment

Participants receive testosterone replacement therapy and undergo periodic clinical and ultrasonographic evaluations

7 months

Monthly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Testosterone Cypionate

Trial Overview The study examines if injecting male-level doses of Testosterone Cypionate affects the reproductive system in healthy females without PCOS (Polycystic Ovary Syndrome).

How Is the Trial Designed?

Group I: Cisgender Female (CGF) control group Active Control 1 Intervention

Cisgender females serving as a control group

Group II: Transgender Men (TGM) initiating Testosterone Replacement Therapy (TRT) Active Control 1 Intervention

Transgender men/non-binary/non-gender-conforming initiating testosterone replacement therapy

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Citations

1. academic.oup.com academic.oup.com/jsm/advance-article/doi/10.1093/jsxmed/qdaf263/8276088?searchresult=1

Effect of 100 mg of testosterone cypionate in trans men with ... Testosterone suspension appears to be more effective in reducing Hct than dose reduction when a decrease greater than 1% in Hct is desired.

2. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/nau.25094

The efficacy, safety, and outcomes of testosterone use ... Testosterone therapy can be impactful for TM population with improved safety, efficiency, quality of life and function. With the rise of the ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8238053/

The effect of testosterone on ovulatory function in ... Importantly, these data also suggest that some long-term testosterone users break through the hormonal suppression and experience an ovulatory event, thereby ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT07092527

Study Details | NCT07092527 | Androgen Effects on the ... This research study investigates whether male-level exogenous androgens inhibit the reproductive neuroendocrine axis in otherwise healthy (non-PCOS) females.

5. journals.lww.com journals.lww.com/10.1097/MED.0000000000000912

Current Opinion in Endocrinology, Diabetes and Obesity This review focuses on updates from the last 18 months mainly in testosterone use in masculinising gender-affirming hormone therapy (GAHT) in postpubertal ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8511909/

Effects of testosterone treatment on transgender males Masculinizing effects developed in all transgender men. There were no changes in body weight, and systolic and diastolic blood pressure.

7. aetna.com aetna.com/cpb/medical/data/1000_1099/1014.html

Testosterone Cypionate Injections - Medical Clinical Policy ... Testosterone cypionate injections are for intramuscular (IM) use only. The suggested dosage varies depending on the age, sex, and diagnosis of the individual.