Gender-Affirming Treatments for Lung Health

Recruiting in Palo Alto (17 mi)

Overseen by Gustavo Cortes Puentes, MD

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Mayo Clinic

Must be taking: Pubertal blockers, hormone therapies

Disqualifiers: Recent surgery, Respiratory disorders, Heart conditions, others

No Placebo Group

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

The purpose of this research study is to evaluate whether undergoing gender affirming care will impact the way the lungs function.

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

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team to get a clear answer.

What data supports the effectiveness of the treatment Gender-Affirming Hormone Therapy (GAHT) for lung health?

While there is no direct evidence linking Gender-Affirming Hormone Therapy (GAHT) to lung health, GAHT is known to greatly improve the quality of life and mental health for individuals seeking gender affirmation. This suggests that GAHT can have positive overall health benefits, which might indirectly support lung health. ^{1 2 3 4 5}

Is gender-affirming hormone therapy (GAHT) safe for humans?

Gender-affirming hormone therapy (GAHT) is generally considered safe when used within established protocols, and it is associated with improvements in mental health, such as reduced depression and anxiety. However, healthcare providers need to manage potential drug interactions and monitor for any adverse effects. ^{1 2 3 6 7}

How is Gender-Affirming Hormone Therapy (GAHT) unique compared to other treatments for lung health?

Gender-Affirming Hormone Therapy (GAHT) is unique because it involves hormone replacement to align an individual's physical characteristics with their gender identity, which is not a standard approach for treating lung health. This therapy focuses on adjusting hormone levels, unlike typical lung treatments that might involve medications targeting lung function directly. ^{8 9 10 11 12}

Eligibility Criteria

This trial is for transgender and gender diverse patients at the Mayo Clinic who are starting hormonal gender-affirming therapies. They must be able to perform lung function tests and give informed consent, or have a guardian's consent if under 18. People with recent heart issues, chronic lung diseases, or those unable to consent are excluded.

Inclusion Criteria

I can perform the required breathing tests for lung function.

Subjects speaking any language will be offered participation

I can give my consent, or if under 18, my parents/guardians can.

Exclusion Criteria

I haven't had any major surgeries in the last 3 months that could affect breathing tests.

Subjects unable to provide consent, or subjects who do not agree to discuss the study with their parents/guardians

I have had lung problems like clots, fluid around lungs, collapsed lung, or coughing up blood recently.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Transgender and gender diverse patients undergo masculinizing or feminizing hormone therapies and have breathing tests to evaluate lung function

18 months

Baseline, 6-month, 12-month, and 18-month follow-up visits

Follow-up

Participants are monitored for changes in pulmonary function after hormone therapy

18 months

6-month, 12-month, and 18-month follow-up visits

Treatment Details

Interventions

• Gender-Affirming Treatments (Behavioural Intervention)

Trial Overview The study is testing how gender-affirming hormone treatments affect lung function in transgender and gender diverse individuals. It involves performing spirometry and plethysmography—tests that measure how well the lungs work.

Participant Groups

Group I: Pulmonary Function in Transgender and Gender Diverse Patients Experimental Treatment 2 Interventions

Transgender and gender diverse (TGD) patients undergoing masculinizing or feminizing hormone therapies will have breathing tests to evaluate their lung function

Gender-Affirming Treatments is already approved in United States, European Union, Canada, Australia for the following indications:

🇺🇸 Approved in United States as Gender-Affirming Hormone Therapy for:

• Gender dysphoria
• Transgender health care

🇪🇺 Approved in European Union as Gender-Affirming Hormone Therapy for:

• Gender dysphoria
• Transgender health care

🇨🇦 Approved in Canada as Hormone Replacement Therapy for:

• Gender dysphoria
• Transgender health care

🇦🇺 Approved in Australia as Gender-Affirming Care for:

• Gender dysphoria
• Transgender health care

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Mayo Clinic Rochester Rochester, MN

Who Is Running the Clinical Trial?

Mayo Clinic Lead Sponsor

References

1. Germany pubmed.ncbi.nlm.nih.gov

Endocrine Therapy of Adult Gender-Incongruent Individuals Seeking Gender Reaffirmation. [2022] Gender-affirming hormone therapy (GAHT) is integral to the management of gender-incongruent (GI) individuals. GAHT greatly improves the quality of life for GI individuals. Current research about outcomes of GAHT and adverse events in adults receiving GAHT is limited in India and large cohort studies are absent. This document on medical management provides protocols for the prescribing clinician relating to counseling for GAHT, baseline evaluation, choice of therapy, targets for hormone therapy, clinical and biochemical monitoring, and perioperative hormone therapy.

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

Endocrinological Follow-Up Characteristics of People Diagnosed with Gender Dysphoria in Turkey. [2023] Various problems related to the gender-affirming therapy (GAT) can adversely affect both the physical and mental health of people diagnosed with gender dysphoria (GD). In this study, we aimed to highlight the reasons for loss to follow-up during the gender-affirming hormone therapy (GAHT), which is an important component of GAT.

3. India pubmed.ncbi.nlm.nih.gov

IDEA Group Consensus Statement on Medical Management of Adult Gender Incongruent Individuals Seeking Gender Affirmation as Male. [2023] Gender-affirming hormone therapy (GAHT) is the most frequent treatment offered to gender-incongruent individuals, which reduces dysphoria. The goal of therapy among gender-incongruent individuals seeking gender affirmation as male is to change their secondary sex characteristics to affect masculine physical appearances. GAHT greatly improves mental health and quality of life among gender incongruent individuals. India-specific guideline for appropriate care for gender-incongruent individuals is almost absent. This document is intended to assist endocrinologists and other healthcare professionals interested in gender incongruity for individuals seeking gender affirmation as male. A safe and effective GAHT regimen aims to effect masculinising physical features without adverse effects. In this document, we offer suggestions based on an in-depth review of national and international guidelines, recently available evidence and collegial meetings with expert Indian clinicians working in this field. Clinicians represented in our expert panel have developed expertise due to the volume of gender incongruent individuals they manage. This consensus statement provides protocols for the hormone prescribing physicians relating to diagnosis, baseline evaluation and counselling, prescription planning for masculinising hormone therapy, choice of therapy, targets for monitoring masculinising hormone therapy, clinical and biochemical monitoring, recommending sex affirmation surgery and peri-operative hormone therapy. The recommendations made in this document are not rigid guidelines, and the hormone-prescribing physicians are encouraged to modify the suggested protocol to address emerging issues.

4. Switzerland pubmed.ncbi.nlm.nih.gov

Short-Term Effects of Gender-Affirming Hormone Therapy on Dysphoria and Quality of Life in Transgender Individuals: A Prospective Controlled Study. [2022] Gender affirming hormone therapy (GAHT), whilst considered the standard of care in clinical guidelines for the treatment of many transgender (trans) people is supported by low quality evidence. In this prospective longitudinal controlled study, we aimed to examine the effect of newly commencing GAHT on gender dysphoria and quality of life (QoL) over a 6 month period.

5. England pubmed.ncbi.nlm.nih.gov

Gender affirming hormonal treatment in Danish transgender persons: A nationwide register-based study. [2022] Gender affirming hormonal treatment (GAHT) is a cornerstone in transgender care. National data are sparse regarding use of hormonal treatment by transgender persons.

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

Hormone Therapy for Transgender Adults. [2019] Transgender people have a gender identity that differs from their sex assigned at birth. For many transgender individuals accessing gender affirming hormone therapy (GAHT) is an important and medically necessary step in their gender transition. Both feminizing and masculinizing regimens are safe when used within established hormone protocols and are associated with significant improvements in mental health outcomes, including reduction in depression, anxiety and gender dysphoria. Clinicians should be aware of the current best practice guidelines for initiating and maintaining patients on GAHT.

7. England pubmed.ncbi.nlm.nih.gov

Drug Interactions with Gender-Affirming Hormone Therapy: Focus on Antiretrovirals and Direct Acting Antivirals. [2022] Gender-affirming care may include hormonal therapy to attain desired health outcomes in transgender (trans) individuals. To provide safe, affirming medical care for trans patients, health care providers must identify and manage drug-drug interactions (DDIs) between gender affirming hormonal therapy (GAHT) and other medication therapies.

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

Hormonal therapy for prostate cancer. [2019] Since the demonstration in 1941 by Huggins and Hodges that prostatic cancers are androgen dependent, hormonal treatment by androgen ablation has been the principal treatment for patients with advanced adenocarcinoma of the prostate. Although not able to permanently and totally eradicate every cancer cell since prostate cancer cells are quite heterogeneous in their sensitivity to androgens, hormonal therapy can produce dramatic subjective improvement as well as objective remissions. This results in an improved quality of survival and for patients with metastatic adenocarcinoma, endocrine therapy does reduce the death rate from cancer, and if death from other concurrent illness is controlled, there is an absolute increase in survival. At present, a variety of strategies are available for ablation of testicular and adrenal androgens, but results are not clinically significantly better than orchiectomy.

9. Netherlands pubmed.ncbi.nlm.nih.gov

Study protocol: Randomized, open-label, non-inferiority clinical trial for evaluating the clinical and pathological response rates to neoadjuvant hormone therapy and chemotherapy in patients with luminal-subtype breast tumors. [2022] Despite neoadjuvant hormone therapy (NHT) is being underused, it is an effective treatment for luminal tumors at a lower cost and with fewer side effects compared to those associated with neoadjuvant chemotherapy (NCT). The lack of robust comparative data between NHT and NCT is a factor that limits its use in clinical practice.

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

Some effects of orchiectomy, oestrogen treatment and radiation therapy in patients with prostatic carcinoma. [2015] In patients treated for prostatic carcinoma with oestrogen, orchiectomy or external radiation, serum concentrations of testosterone, LH, FSH, prolactin, TeBG and oestradiol-17 beta as well as changes in sexual behaviour and mental mood were studied. Oestrogen treatment as well as orchiectomy reduced serum testosterone concentration to similar values. Neither totally nor subcapsularly orchiectomized patients responded to HCG stimulation. The free testosterone was 68% lower in oestrogen treated than in orchiectomized patients, probably due to a high TeBG concentration induced by oestrogens. patients oestrogen treated for less than 3 years and in whom the treatment had been withdrawn had normal serum testosterone and LH at follow-up. In contrast, low serum testosterone concentration and normal LH were found after oestrogen cessation in patients oestrogen treated for more than 3 years indicating reduced Leydig cell, and/or hypothalamic-hypophyseal function. In patients oestrogen treated for more than 3 years the serum testosterone concentration neither increased after oestrogen cessation nor decreased after orchiectomy. Absorbed testes doses during radiation treatment were measured from a few to more than 10 Gy but were reduced by about 50% if the gonads were protected by lead shields during anterior and posterior treatment sessions. Radiation may affect gonadal function as decreased serum testosterone concentration and increased LH, FSH were found after treatment. Sexual function was altered after oestrogen, orchiectomy and radiation treatment. Sexual activity and capability were distinctly better maintained after radiation than after orchiectomy or oestrogen treatment. Sixty-seven percent of the patients had coitus or masturbated after radiation treatment, all experiencing orgasm. Patients on oestrogen treatment or after orchiectomy had coitus/masturbation less often (17% in both groups). They also experienced orgasm less often (8% and 17% respectively). The group of patients on oestrogen treatment had a higher average score for depression than those treated with orchiectomy or radiation treatment.

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

Effect of adjuvant hormone therapy in patients with prostate cancer: A meta-analysis of randomized controlled trials. [2022] To summarize the evidence regarding the treatment effect of adjuvant hormone therapy (AHT) in patients with prostate cancer (PCa). AHT following radiotherapy, chemotherapy, or surgery is widely used in patients with PCa. However, the treatment effect is inconsistent in individual trials.

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

Hormonal therapy of prostate cancer: current concepts and future prospects. [2005] The goal of hormonal treatment of prostate cancer is to deprive the prostatic cancer cell of androgen. This may be achieved by orchiectomy, a simple and safe procedure (but one which may have adverse psychological consequences), or by the administration of estrogens--particularly diethylstilbestrol (with its attendant risk of thromboembolic complications), synthetic analogs of luteinizing hormone-releasing hormone (which seem to be effective and free of side effects), or antiandrogens (whose effectiveness and safety are being tested). All treatments that deprive the cancer cell of androgen seem to be equally effective. Selection of treatment thus depends on patient preference, potential side effects, and cost.