transgender women
Conditions
Interventions
Estradiol Oral Tablets:cyproterone acetate (25 mg initially, 12.5 mg maintenance after 8 weeks) + estradiol oral agent 3 mg + placebo gel
Estradiol Gel:cyproterone acetate (25 mg initially, 12.5 mg maintenance after 8 weeks) + estradiol gel 3 mg + placebo oral
Control group:Cyproterone acetate (25 mg initially, 12.5 mg maintenance after 8 weeks) + placebo gel + placebo oral.
Sponsors
The First Affiliated Hospital of Jinan University
Eligibility
Sex/Gender
Male
Age
16 Years to 40 Years
Inclusion criteria
Inclusion criteria: (1) 16-40 years old (over 16 years old, under 18 years old need to sign at least one parent); (2) Transgender women who have been professionally evaluated and diagnosed by psychiatrists from tertiary hospitals; (3) I have a strong desire for hormone therapy; (4) Those who have not received sex hormone drugs or although they are treated with hormone drugs, but the breast glands have not developed, the drug has been discontinued for more than one month, and the sex hormone examination is at the physiological level of cisgender men; (5) Those who have not undergone gender reassignment surgery; (6) Have the ability to read and comprehend clearly and complete research questionnaires.
Exclusion criteria
Exclusion criteria: 1. Those with contraindications to the use of estrogens and cyproterone acetate; 2. Pre-pubertal or post-menopausal; 3. Those with a combination of major medical or surgical disease; 4. Those with a combination of severe psychosomatic illness/inability to care for themselves/incapacity; 5. Those with a history of deep vein thrombosis of the lower extremities, patients with malignancy and other chronic diseases; 6. Patients who are hesitant or uncooperative; 7. Patients who cannot be followed up as required; 8. Use of drugs that affect the metabolism of the study drug; 9. Having participated in other clinical trials within 3 months; 10. Those who have not undergone an assessment related to fertility effects; 11. Other circumstances that prevent the completion of the trial or follow-up, or that the investigator considers inappropriate (e.g., if further examination or diagnosis of the patient's condition is required to avoid harm to the patient).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Breast changes; | — |
Secondary
| Measure | Time frame |
|---|---|
| Body hair changes;Body fat percentage;Dimension;Sex hormones;Brain function;Genital changes;Gender Dysphoria; | — |
Countries
China
Contacts
Public ContactLvfen Gao
The First Affiliated Hospital of Jinan University
Outcome results
None listed