What side effects are associated with this type of intervention?

Depo Medroxyprogesterone (DMPA) is commonly used in gender dysphoria treatment to prevent ovulation and thicken cervical mucus. Known side effects of DMPA include menstrual irregularities, weight gain, decreased bone mineral density, and an increased risk of venous thromboembolism (VTE). Other hormonal treatments for gender dysphoria, such as estrogen and testosterone therapies, can also have side effects like mood changes, cardiovascular risks, and changes in lipid profiles. It is important for patients to discuss these potential side effects with their healthcare provider to make informed decisions about their treatment.

What prior FDA approvals exist?

The FDA has approved several hormonal treatments for gender dysphoria, which include medications that prevent ovulation and alter secondary sexual characteristics. Depo Medroxyprogesterone Acetate (DMPA) is one such treatment, commonly used to suppress menstruation and reduce estrogen levels in transgender men. Other related drugs include testosterone, which is used to induce masculinization in transgender men, and estrogen, along with anti-androgens like spironolactone, used to promote feminization in transgender women. These treatments help align physical characteristics with gender identity by modulating hormone levels and secondary sexual traits.

What other types of research exist?

Promising alternatives to Depo Medroxyprogesterone for Gender Dysphoria patients include combined oral contraceptives containing gestodene/ethinyl estradiol or desogestrel/ethinyl estradiol. These combinations have shown good contraceptive efficacy, cycle control, and tolerance. Additionally, continuous regimens of levonorgestrel/ethinyl estradiol may also be considered for their effectiveness and potential benefits in managing menstrual-related symptoms.

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Contraceptive Counseling for Gender Dysphoria

Phase 4

Recruiting

Research Sponsored by University of Colorado, Denver

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up between 6 and 12 months of first dmpa administration

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

No Placebo-Only Group

Summary

This trial aims to improve contraceptive counseling for transgender youth assigned female at birth by focusing on their experiences with the DMPA birth control shot. The study will gather insights through focus groups and interviews to help create better counseling practices. Depot medroxyprogesterone acetate (DMPA) is a highly effective injectable form of birth control that has been the focus of recent research to improve accessibility and side-effect profiles.

Who is the study for?

This trial is for transgender and gender diverse youth, assigned female at birth, aged 15-21, who are patients at certain clinics. It's for those currently using or interested in using the contraceptive Depo Medroxyprogesterone (DMPA). Those with health conditions that make DMPA unsafe based on CDC guidelines cannot participate.

What is being tested?

The study aims to develop best practices for contraceptive counseling tailored to transgender and gender diverse adolescents. It involves focus groups and interviews with participants about their experiences with DMPA to improve satisfaction and counseling methods.

What are the potential side effects?

While this study focuses on counseling rather than direct medical intervention, it should be noted that DMPA itself can have side effects such as changes in menstrual periods, weight gain, headaches, mood changes, or bone density loss over time.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ between 6 and 12 months of first dmpa administration

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~between 6 and 12 months of first dmpa administration

This trial's timeline: 3 weeks for screening, Varies for treatment, and between 6 and 12 months of first dmpa administration for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Satisfaction with DMPA Administered in an Office Setting

Satisfaction with Self-administered DMPA after two injections

Satisfaction with Self-administered DMPA at initiation

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Depo SC HomeExperimental Treatment1 Intervention

Participants will be given instructions on home administration of DMPA SC and be provided with all necessary supplies.

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Gender Dysphoria, such as Depo Medroxyprogesterone (DMPA), work by preventing ovulation and thickening cervical mucus, which helps suppress menstruation and alleviate gender dysphoria in transgender and gender diverse individuals assigned female at birth. Other treatments, like GnRH agonists and estradiol, are used in male-to-female transitions to suppress testosterone and promote feminization. These mechanisms are important as they help TGD patients achieve desired physical changes and improve their overall well-being by aligning their physical appearance with their gender identity.

Experimental and clinical data on Cyclabil.Endometrial preparation for women undergoing embryo transfer with frozen embryos or embryos derived from donor oocytes.Low-Dose Cyproterone Acetate Treatment for Transgender Women.