Contraceptive Counseling for Gender Dysphoria

Overseen By Eva M Dindinger, MPH

Age: < 65

Sex: Female

Trial Phase: Phase 4

Sponsor: University of Colorado, Denver

Must be taking: Depo medroxyprogesterone

Disqualifiers: Contraindications to DMPA, 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: Unknown

Duration: 6-12 months

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve contraceptive counseling practices for transgender and gender diverse (TGD) youth. It focuses on individuals assigned female at birth who are using or interested in depo medroxyprogesterone (DMPA), a type of birth control. The research includes focus groups and interviews to assess TGD youth satisfaction with DMPA and to guide healthcare providers in offering more inclusive counseling. Eligible participants are TGD youth, assigned female at birth, receiving care at specific clinics, and using or interested in DMPA. As a Phase 4 trial, this research involves an FDA-approved treatment and seeks to enhance its benefits for more patients.

Do I have to stop taking my current medications for this trial?

The trial information does not specify if you need to stop taking your current medications. It focuses on participants who are using or interested in using DMPA (a type of birth control shot).

What is the safety track record for these treatments?

Research has shown that depo medroxyprogesterone (DMPA) is generally well-tolerated. Over time, fewer users experience irregular bleeding, and many stop having periods altogether. Although limited information exists on DMPA's safety specifically for transgender and gender-diverse individuals, its use in other groups suggests it is safe for many.

The FDA has approved DMPA for use as a contraceptive, indicating a strong safety record. Most side effects are mild and may include changes in menstrual bleeding, weight gain, and headaches. Serious side effects are rare. Always discuss any concerns about using DMPA with a healthcare provider. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the contraceptive counseling for gender dysphoria trial because it introduces a novel method of delivering depot medroxyprogesterone acetate (DMPA SC) through home administration. Traditionally, contraceptive injections like DMPA are administered in a clinical setting, which can be inconvenient and less accessible for some individuals. By allowing participants to self-administer the treatment at home, this trial offers a more flexible and potentially empowering option for those undergoing gender dysphoria treatment. This approach could enhance adherence and satisfaction, making it a promising development in contraceptive care.

What evidence suggests that this trial's treatments could be effective for contraceptive counseling in TGD youth?

Research has shown that Depo-SubQ Provera, a form of birth control, is both effective and safe. In this trial, participants will receive instructions on administering Depo-SubQ Provera at home and will be provided with all necessary supplies. Studies have found that individuals can successfully self-administer the injection and are generally very satisfied with it. It is particularly helpful for managing periods, benefiting transgender and gender-diverse young people who wish to stop menstruation. Additionally, Depo-SubQ Provera has few side effects and supports gender-affirming therapy by aligning physical traits with gender identity. This makes it a valuable option for those transitioning and seeking birth control solutions. ^{4 5 6 7 8}

Who Is on the Research Team?

Eva M Dindinger, MPH

Principal Investigator

University of Colorado, Denver

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Currently receiving care at one of the clinic sites

I am between 15 and 21 years old.

I was assigned female at birth, identify as transgender or non-binary, and use or am interested in using DMPA.

Exclusion Criteria

I have no health conditions that prevent me from using DMPA.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive instructions on home administration of DMPA SC and participate in focus groups and interviews

6-12 months

Multiple focus groups and interviews

Follow-up

Participants are monitored for satisfaction with DMPA administration and counseling effectiveness

2 months

What Are the Treatments Tested in This Trial?

Interventions

• Counseling
• Depo-subQ Provera Injectable Product

Trial Overview 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.

How Is the Trial Designed?

Group I: Depo SC Home Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

Published Research Related to This Trial

A survey of 200 physicians revealed that while most (83%) recognize the importance of contraceptive counselling for women with chronic diseases, only 5% had received recent training in this area, indicating a significant gap in knowledge and practice.

Two-thirds of physicians consistently asked about contraception, primarily when prescribing potentially harmful medications or when pregnancy posed health risks, but many lacked awareness of available Family Planning resources, highlighting the need for better training and communication in reproductive health care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physician awareness regarding contraceptive counselling in women with chronic disease. Miranda-Silva, C., Mendes-Coutinho, F., Ferreira, I., et al.[2022]

A study involving 18,521 women revealed that while 61% were using oral contraceptives, only 9% opted for long-acting reversible contraception (LARC), despite 60% expressing interest in LARC if given more information.

Gynecologists significantly underestimated their patients' interest in long-term contraception options, believing only 18% would consider it, while nearly half of the women reported forgetting to take their oral contraceptive at least once in the past three months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What do patients want to know about contraception and which method would they prefer? Oppelt, PG., Baier, F., Fahlbusch, C., et al.[2022]

There is a significant lack of professional guidelines and data on contraceptive use for transgender and gender-diverse (TGD) populations, which limits clinicians' ability to provide informed counseling on safety, efficacy, and side effects.

When counseling TGD patients about contraceptive options, providers should focus on shared decision-making, consider unique experiences and barriers faced by these individuals, and create an inclusive and supportive environment for discussions about reproductive health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Society of Family Planning clinical recommendations: Contraceptive counseling for transgender and gender diverse people who were female sex assigned at birth. Bonnington, A., Dianat, S., Kerns, J., et al.[2021]

Gender-affirming hormone treatment (GAHT) has been shown to improve mental health and life satisfaction in transgender and gender nonbinary individuals, despite their higher prevalence of mental health issues compared to cisgender individuals.

While GAHT can positively affect body composition and contours, there are important safety considerations, such as the increased risk of myocardial infarction and stroke in trans women, highlighting the need for lifestyle management in their healthcare.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gender-affirming hormone therapy: An updated literature review with an eye on the future. D'hoore, L., T'Sjoen, G.[2022]

Transsexual patients require a comprehensive approach to care that includes psychological evaluation, hormone therapy, and sex reassignment surgery, emphasizing the importance of interdisciplinary collaboration in treatment.

Cross-sex hormone therapy is crucial for both the anatomical and psychological transition of transgender individuals, significantly improving their quality of life and reducing associated psychiatric issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical practice guidelines for assessment and treatment of transsexualism. SEEN Identity and Sexual Differentiation Group (GIDSEEN)]. Moreno-Pérez, O., Esteva De Antonio, I.[2014]

Primary care practitioners are encouraged to adopt ten key principles to create welcoming environments and provide quality care for transgender patients, addressing significant healthcare disparities.

Transwomen can benefit from hormone treatments like estrogens, which promote physical changes but carry risks such as thrombosis, while transmen can use testosterone with generally fewer risks, highlighting the importance of monitoring and communication in their care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ten Most Important Things to Know About Caring for Transgender Patients. Chipkin, SR., Kim, F.[2018]

The guidance emphasizes the importance of culturally competent contraception counseling that respects individual beliefs and preferences, promoting patient autonomy in family planning decisions.

Implementing these recommendations can reduce coercive practices in contraceptive care, particularly for vulnerable populations, leading to improved patient experiences and better health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Committee Opinion No. 419: Coercion Free Contraceptive Care. Black, A., Bow, M., Armson, BA., et al.[2021]

In a study of 342 reproductive-age women, it was found that counseling about combined hormonal contraceptive (CHC) methods was inconsistent, with providers often failing to discuss all available options and their side effects, which can affect patient satisfaction and method continuation.

Women with no pre-visit method preference or those preferring the ring or patch received more comprehensive counseling compared to those preferring combined oral contraceptives, highlighting a need for improved training for providers to ensure all methods are adequately discussed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pill, patch or ring? A mixed methods analysis of provider counseling about combined hormonal contraception. Craig, AD., Steinauer, J., Kuppermann, M., et al.[2021]

Reproductive life plan counseling (RLPC) did not significantly increase overall contraceptive use among 771 nonpregnant women receiving gynecological services, indicating limited efficacy of this intervention in promoting effective contraception.

However, RLPC may have a positive effect on increasing the use of long-acting reversible contraception (LARC) compared to nonmedical or no method, suggesting a potential area for further development in counseling strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reproductive Life Plan Counseling and Effective Contraceptive Use among Urban Women Utilizing Title X Services. Bommaraju, A., Malat, J., Mooney, JL.[2018]

In a study of 388 transgender individuals (155 transwomen and 233 transmen) receiving gender-affirming hormone therapy, the median time for transmen to achieve amenorrhea was 3 months, indicating effective treatment outcomes.

The study found that gender-affirming hormone therapy is generally safe, with rare and mostly transient elevations in liver values and manageable side effects, such as acne and erythrocytosis in transmen, and venous thromboembolism in transwomen.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and rapid efficacy of guideline-based gender-affirming hormone therapy: an analysis of 388 individuals diagnosed with gender dysphoria. Meyer, G., Mayer, M., Mondorf, A., et al.[2022]

Hormone therapy for gender dysphoria, including medications like 17-beta-estradiol and testosterone, is increasingly prescribed in general practice to help align physical characteristics with a person's experienced gender, benefiting both transgender and gender nonconforming individuals.

The review highlights the importance of understanding the pharmacodynamics, dosing, and potential adverse effects of these therapies, while also addressing gaps in research regarding optimal administration routes and long-term risks as patients age.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of adult gender transition medications: mechanisms, efficacy measures, and pharmacogenomic considerations. Sehgal, I.[2023]

In transgender women undergoing estrogen therapy, there was a significant reduction in blood pressure from a median of 130.5 mmHg to 120.5 mmHg over 6 months, indicating a potential cardiovascular benefit from hormone therapy.

Transgender men experienced an increase in body mass index (BMI) from a median of 29.1 kg/m² to 30.0 kg/m² after 6 months of testosterone therapy, suggesting a need for monitoring weight changes during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of cross-sex hormone treatment on transgender women and men. Deutsch, MB., Bhakri, V., Kubicek, K.[2022]

In a study analyzing 28 adverse drug reactions (ADRs) related to gender-affirming hormone therapy from the French pharmacovigilance database, significant cardiovascular events were reported in transgender men, particularly pulmonary embolism in 50% of cases, highlighting a potential safety concern for this group.

Transgender women experienced a high incidence of meningiomas and cardiovascular events, with antiandrogens and estrogens being commonly involved, indicating the need for further research to identify risk factors and improve treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse effects of gender-affirming hormonal therapy in transgender persons: Assessing reports in the French pharmacovigilance database. Yelehe, M., Klein, M., El Aridi, L., et al.[2022]

There is a growing need for evidence-based guidelines for gender-affirming care, particularly hormone therapy, as more transgender and gender diverse individuals seek these services.

Current research on the impact of gender-affirming hormone therapy on cancer risk is limited, highlighting the necessity for dedicated studies to better understand potential cancer risks in the transgender and gender diverse population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gender-affirming care and endocrine-related cancers. Harty, R., Safer, JD.[2023]

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1083318823003431

A Pilot Study of Adolescent and Young Adult Experience ... The objectives of this study were to describe satisfaction with and preference for DMPA-SC, as well as adherence and feasibility in AYAs receiving care within ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10017940/

Reversible interventions for menstrual management in ... This is a review of current evidence-based options for reversible interventions for menstrual suppression in adolescents with gender dysphoria or incongruence.

3. aafp.org aafp.org/pubs/afp/issues/2022/0900/contraception.html

Evidence-Based Contraception: Common Questions and ... Subcutaneous depot medroxyprogesterone acetate, 104 mg (Depo-SubQ Provera) can be self-administered safely and effectively. ... Use of ...

4. researchgate.net researchgate.net/publication/332658258_Medroxyprogesterone_Acetate_in_Gender-Affirming_Therapy_for_Transwomen_Results_From_a_Retrospective_Study

Medroxyprogesterone Acetate in Gender-Affirming Therapy ... We found minimal side effects, unchanged estradiol levels, and a decline in testosterone associated with MPA--outcomes consistent with feminization.

5. link.springer.com link.springer.com/article/10.1007/s13669-024-00387-w

Contraception and Menstrual Management in ... This review outlines the current evidence on the contraceptive and menstrual management methods that are used for transmasculine or gender-diverse (TGD) ...

6. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2019/021583s016,%20s024,%20s029lbl.pdf

DEPO-SUBQ PROVERA 104® - accessdata.fda.gov (6.1)]. Fewer women experienced irregular bleeding and more experienced amenorrhea with longer term use of depo-subQ provera 104, consistent ...

7. healio.com healio.com/clinical-guidance/drugs/depo_subq_provera

Depo-SubQ Provera: Uses, Side Effects & Dosage Find clinical guidance on Depo-SubQ Provera, including indications, dosing, safety, side effects and evidence-based insights for healthcare professionals.

8. withpower.com withpower.com/trial/phase-4-gender-dysphoria-11-2022-55666

Contraceptive Counseling for Gender Dysphoria There is limited data on the safety of contraceptive methods for transgender and gender-diverse people, especially when combined with gender-affirming hormone ...