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

Trial Summary

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 data supports the effectiveness of the treatment for Contraceptive Counseling for Gender Dysphoria?

Gender-affirming hormone therapy, which is part of the treatment for gender dysphoria, has been shown to improve mental health and life satisfaction for those who need it. Hormone therapy helps align physical characteristics with gender identity, which can enhance quality of life and reduce psychological difficulties. ^{1 2 3 4 5}

Is contraceptive counseling for gender dysphoria safe?

There is limited data on the safety of contraceptive methods for transgender and gender-diverse people, especially when combined with gender-affirming hormone therapy. Providers often rely on data from cisgender women and clinical expertise to guide counseling, but specific safety information for this population is scarce. ^{1 6 7 8 9}

How is the treatment 'Contraceptive Counseling for Gender Dysphoria' different from other treatments?

This treatment is unique because it focuses on providing personalized counseling to help individuals with gender dysphoria make informed decisions about contraception, emphasizing shared decision-making and patient autonomy, rather than prescribing a specific medication or procedure. ^{10 11 12 13 14}

What is the purpose of this trial?

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.

Research Team

Eva M Dindinger, MPH

Principal Investigator

University of Colorado, Denver

Eligibility Criteria

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

I am between 15 and 21 years old.

Currently receiving care at one of the clinic sites

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Gender-affirming care and endocrine-related cancers. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Gender-affirming hormone therapy: An updated literature review with an eye on the future. [2022]

3. Spain pubmed.ncbi.nlm.nih.gov

[Clinical practice guidelines for assessment and treatment of transsexualism. SEEN Identity and Sexual Differentiation Group (GIDSEEN)]. [2014]

4. England 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. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

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

6. United States pubmed.ncbi.nlm.nih.gov

Ten Most Important Things to Know About Caring for Transgender Patients. [2018]

7. United States 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. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Effects of cross-sex hormone treatment on transgender women and men. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Adverse effects of gender-affirming hormonal therapy in transgender persons: Assessing reports in the French pharmacovigilance database. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Physician awareness regarding contraceptive counselling in women with chronic disease. [2022]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Committee Opinion No. 419: Coercion Free Contraceptive Care. [2021]

12. United States pubmed.ncbi.nlm.nih.gov

Reproductive Life Plan Counseling and Effective Contraceptive Use among Urban Women Utilizing Title X Services. [2018]

13. Germany pubmed.ncbi.nlm.nih.gov

What do patients want to know about contraception and which method would they prefer? [2022]

14. United States pubmed.ncbi.nlm.nih.gov

Pill, patch or ring? A mixed methods analysis of provider counseling about combined hormonal contraception. [2021]