Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:11 AM
Ignite Modification Date:
2025-12-25 @ 3:11 AM
NCT ID:
NCT05649605
Eligibility Criteria:
Inclusion criteria:
1. Well-informed written consent to participate in the study.
2. Transgender man given the ICD-10 diagnosis of transsexualism.
3. A desire for complete gender-confirming hormonal treatment.
4. Approved for Nebido treatment by a clinically responsible Endocrinologist.
Exclusion criteria:
1. A concomitant hormonal condition affecting the gonadal axis (e.g. Congenital Adrenal Hyperplasia, Poly Cystic Ovary Syndrome, Complete Androgen Insensitivity Syndrome, Partial Androgen Insensitivity Syndrome, untreated thyroid disease, untreated hypercortisolism, etc.).
2. A disability that prevents the patient from fully participating in the study.
3. Treatment with steroid hormones (androgens, estrogens, progestogens, or continuous treatment with oral corticosteroids within the last three months).
4. Previous use of hormone preparations without a doctor's prescription.
5. Laboratory samples significantly outside the normal reference range.
6. Anamnestic or investigational suspicion of breast cancer or existing or previous liver tumors.
7. Levels of P-ASAT, P-ALAT, or P-GT at the screening time that are\> 2 times the reference range.
8. Hypersensitivity to the active substance or to any of the excipients.
9. Ongoing pregnancy or wishes for a pregnancy in the near future.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT05649605
Study Brief:
Protocol Section:
NCT05649605