Gender Incongruence (Transgender Men)
Conditions
Interventions
Cernos(1000 mg) will be administered as an initial injection, followed by a second injection at 6 weeks, and subsequently every 12 weeks via intramuscular injection. The treatment duration is 12 month
Sponsors
Tominaga Yusuke
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: The study will include subjects who meet all of the following criteria: Individuals who are 18 years of age or older at the time of obtaining consent. Individuals diagnosed with gender incongruence (GI: transgender men) and approved for hormone therapy by the judgment committee of our hospital's Gender Center. Individuals who, after receiving sufficient explanation about participation in this study, have provided written informed consent of their own free will, based on a thorough understanding.
Exclusion criteria
Exclusion criteria: Individuals who meet any of the following criteria will not be included in this study: Those who have undergone male hormone therapy in the past. Those with severe obesity (BMI 28 or higher) or untreated sleep apnea syndrome. Those with severe liver or kidney dysfunction that makes continued male hormone therapy difficult. Any other patients whom the principal investigator or co-investigators deem unsuitable as research subjects.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint will be the change in satisfaction scores from baseline (treatment expectation at Cernos injection initiation) to 12 months post-treatment initiation for the following six patient-reported subjective symptoms: (1) Patient satisfaction, (2) Cessation of menstruation, (3) Voice deepening, (4) Physical build changes, (5) Increased body hair, and (6) Enhanced sexual function/libido. All items will be self-assessed using an 11-point numerical rating scale (NRS) ranging from 0 to 10 (0: no effect at all, 10: very effective). The primary analysis will employ the following indicators: raw change from baseline for individual item scores, change from baseline for composite score (mean of six items), and clinically significant improvement rate (proportion of subjects with change of 2 points or greater). Additionally, identical questionnaires will be administered at 6, 18, 30, and 42 weeks to evaluate temporal changes. The primary analysis will be based on data at the 12-month time point, with results from 6, 18, 30, and 42 weeks treated as supplementary analyses for temporal progression assessment. Multiple comparison corrections will be applied as necessary. For acne, facial hair, scalp hair, and mood fluctuations, responses will be obtained using a three-point scale (improvement, no change, deterioration) compared to the previous examination, and distribution proportions will be calculated at each evaluation time point. Rationale for endpoint selection: Testosterone administration represents a crucial step for transgender men to achieve physical characteristics consistent with their gender identity. Treatment is frequently initiated by individuals seeking cessation of menstruation, physical masculinization (changes in body build, increased body hair, voice deepening), and psychological stability. This study employs an 11-point scale (0-10) to quantitatively evaluate changes in these subjective symptoms before and after administration, thereby objectively | — |
Secondary
| Measure | Time frame |
|---|---|
| Body composition: Changes and percentage changes in the following parameters measured by bioelectrical impedance analysis (InBody) at baseline and 12 months post-treatment initiation: Muscle mass (kg): Change and percentage change from baseline for total muscle mass and regional muscle mass (%) Body fat percentage (%): Change from baseline for total body fat percentage and regional body fat percentage (percentage points) Body weight (kg): Change from baseline (kg) and percentage change (%) Laboratory examinations: Changes and percentage changes in the following laboratory values at baseline and 12 months post-treatment initiation: Hemoglobin (g/dL): Change from baseline (g/dL) Hematocrit (%): Change from baseline (percentage points) Liver function tests (AST, ALT, gamma-GTP): Change from baseline (U/L) Lipid metabolism (total cholesterol, LDL-C, HDL-C, triglycerides): Change from baseline (mg/dL) and percentage change (%) Uric acid: Change from baseline (mg/dL) For both body composition and laboratory examinations, identical assessments will be conducted at 6, 18, 30, and 42 weeks to evaluate temporal changes. Rationale for endpoint selection: Assessment of muscle mass and body fat percentage compared to pre-administration levels serves as important objective indicators for measuring the efficacy and safety of physical masculinization effects induced by Cernos injection. To ensure the safety of study participants by evaluating high-frequency adverse events such as polycythemia, hepatic dysfunction, and hyperuricemia. | — |
Contacts
Public ContactTakatoshi Moriwake
Okayama University Hospital
Outcome results
None listed