Gender-Affirming Treatments for Lung Health

Overseen By Kayla MacDonald, MS

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Must be taking: Pubertal blockers, hormone therapies

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

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 12

Duration: 18 months

44 Participants Needed

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}

Research Team

Gustavo Cortes Puentes, MD

Principal Investigator

Mayo Clinic

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.

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

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 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

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Findings from Research

Gender-affirming hormone therapy (GAHT) is crucial for improving the quality of life for gender-incongruent individuals, highlighting its importance in their medical management.

This document provides essential protocols for clinicians in India regarding GAHT, including counseling, baseline evaluations, therapy choices, and monitoring, addressing the lack of large cohort studies on GAHT outcomes and adverse events in the region.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endocrine Therapy of Adult Gender-Incongruent Individuals Seeking Gender Reaffirmation. Majumder, A.[2022]

A study of 438 individuals undergoing gender-affirming hormone therapy (GAHT) revealed that mental health issues were the most common health problems reported, highlighting the need for mental health support during treatment.

Key factors affecting follow-up included legal and financial barriers, lack of time, and dissatisfaction with healthcare, while those who regularly attended follow-ups had more family support and a desire for supervised therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endocrinological Follow-Up Characteristics of People Diagnosed with Gender Dysphoria in Turkey. Durcan, E., Sulu, C., Şahin, S., et al.[2023]

Gender-affirming hormone therapy (GAHT) is effective in reducing dysphoria and significantly improves mental health and quality of life for gender-incongruent individuals seeking male gender affirmation.

This consensus statement provides essential protocols for healthcare professionals in India, focusing on safe and effective GAHT regimens, monitoring, and recommendations for surgery, based on a comprehensive review of guidelines and expert input.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

IDEA Group Consensus Statement on Medical Management of Adult Gender Incongruent Individuals Seeking Gender Affirmation as Male. Majumder, A., Chatterjee, S., Maji, D., et al.[2023]

In a study of 117 participants, including 42 starting masculinising and 35 starting feminising gender affirming hormone therapy (GAHT), significant reductions in gender dysphoria were observed after 6 months, particularly in those receiving masculinising therapy.

Masculinising GAHT also led to notable improvements in emotional well-being and social functioning, while feminising GAHT reduced gender dysphoria but did not show significant changes in quality of life, indicating a need for additional support for those undergoing feminisation.

NCBI (Pubmed)

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. Foster Skewis, L., Bretherton, I., Leemaqz, SY., et al.[2022]

From 2000 to 2018, the use of gender affirming hormonal treatment (GAHT) among transgender individuals in Denmark significantly increased, with rates for transgender women rising from 4.0 to 20.6 events per 100 person-years and for transgender men from 4.2 to 18.8 events per 100 person-years.

The study found a low discontinuation rate of GAHT at 0.06 per person-year, indicating high adherence to treatment among transgender individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gender affirming hormonal treatment in Danish transgender persons: A nationwide register-based study. Glintborg, D., Rubin, KH., Kristensen, SB., et al.[2022]

Gender affirming hormone therapy (GAHT) is a crucial and medically necessary treatment for many transgender individuals, leading to significant improvements in mental health outcomes such as reduced depression, anxiety, and gender dysphoria.

Both feminizing and masculinizing hormone regimens are considered safe when following established protocols, highlighting the importance of clinicians being knowledgeable about best practice guidelines for GAHT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hormone Therapy for Transgender Adults. Radix, A.[2019]

Gender-affirming hormonal therapy (GAHT) can interact with certain antiretrovirals (ARVs) and hepatitis C direct acting antivirals (DAAs), potentially affecting the effectiveness and safety of the treatments, particularly with non-nucleoside reverse transcriptase inhibitors and protease inhibitors.

Clinicians need to carefully assess drug-drug interactions and overlapping side effects when prescribing GAHT alongside ARVs or DAAs to ensure safe and effective care for transgender patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drug Interactions with Gender-Affirming Hormone Therapy: Focus on Antiretrovirals and Direct Acting Antivirals. Cirrincione, LR., Senneker, T., Scarsi, K., et al.[2022]

Hormonal treatment through androgen ablation has been the main approach for advanced prostate cancer since 1941, leading to significant improvements in patient quality of life and survival rates, especially in metastatic cases.

While various strategies exist for reducing androgen levels, none have shown to be significantly more effective than orchiectomy (surgical removal of the testicles) in clinical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hormonal therapy for prostate cancer. Rosenberg, AG., von Eschenbach, AC.[2019]

This study aims to demonstrate that neoadjuvant hormone therapy (NHT) is as effective as neoadjuvant chemotherapy (NCT) for treating HER2-negative luminal-subtype breast cancer, potentially offering a safer and less costly alternative.

The trial will involve 260 patients (130 in each treatment group) and is designed to show that NHT can achieve similar treatment outcomes as NCT, which could improve access to effective cancer care for patients with limited resources.

NCBI (Pubmed)

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. Gouveia, MC., Amorim de Araújo Lima Santos, C., Impieri Souza, A.[2022]

Oestrogen treatment and orchiectomy both significantly lower serum testosterone levels, but oestrogen-treated patients showed a greater reduction in free testosterone due to increased TeBG levels, which may affect sexual function.

Patients who underwent radiation treatment for prostatic carcinoma maintained better sexual activity and mood compared to those treated with oestrogen or orchiectomy, with 67% reporting sexual activity post-radiation versus only 17% in the other groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Some effects of orchiectomy, oestrogen treatment and radiation therapy in patients with prostatic carcinoma. Tomić, R.[2015]

Adjuvant hormone therapy (AHT) significantly improves overall survival and disease-free survival in prostate cancer patients, as shown by a meta-analysis of 27 randomized controlled trials involving a total of 14,594 studies.

Patients receiving AHT also experienced lower rates of total mortality, recurrence, and disease-specific mortality compared to control groups, although no significant difference was found in response rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of adjuvant hormone therapy in patients with prostate cancer: A meta-analysis of randomized controlled trials. Liu, F., Sun, D., Zhou, X., et al.[2022]

Hormonal treatment for prostate cancer aims to reduce androgen levels, and various methods like orchiectomy and medications can achieve this effectively, with all methods showing similar efficacy.

While orchiectomy is a safe procedure, it may have psychological effects, and other treatments like estrogens and synthetic hormone analogs have their own risks, making patient preference and side effects important factors in treatment selection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hormonal therapy of prostate cancer: current concepts and future prospects. Smith, JA.[2005]

References

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

Endocrine Therapy of Adult Gender-Incongruent Individuals Seeking Gender Reaffirmation. [2022]

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

Endocrinological Follow-Up Characteristics of People Diagnosed with Gender Dysphoria in Turkey. [2023]

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]

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]

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

Gender affirming hormonal treatment in Danish transgender persons: A nationwide register-based study. [2022]

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

Hormone Therapy for Transgender Adults. [2019]

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

Drug Interactions with Gender-Affirming Hormone Therapy: Focus on Antiretrovirals and Direct Acting Antivirals. [2022]

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

Hormonal therapy for prostate cancer. [2019]

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]

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

Some effects of orchiectomy, oestrogen treatment and radiation therapy in patients with prostatic carcinoma. [2015]

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]

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

Hormonal therapy of prostate cancer: current concepts and future prospects. [2005]