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:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2025-12-24 @ 5:00 PM
NCT ID:
NCT04545450
Eligibility Criteria:
Inclusion Criteria:
* Healthy transmen
* Previous bilateral gonadectomy during sex reassigning surgery
* Body Mass Index (BMI) between 20 and 29 kg/m²; (body weight in kilograms divided by body height in meters squared)
* Clinical examination without pathological findings relevant to the study
* No concomitant use of drugs known to affect the hypothalamic-pituitary-ovarian axis
* Written Consent Form
* High probability of a good compliance and termination of the study
Exclusion Criteria:
* Participation in another clinical trial within the 30 days preceding the first administration
* Simultaneous participation in another clinical trial
* Subjects institutionalized or imprisoned by order of the court
* Subject who compete in sports
* Subjects reporting desire to perform regular physical exercises for the duration of the study
* Serious organic or psychic disease suspected from history and/or clinical examination
* Diseases (especially tumors) that might represent an actual contraindication for testosterone
* Past or present history of thrombotic or embolic diseases
* Arterial hypertension
* Diabetes mellitus
* Acute or chronic hepatic diseases
* Manifest renal diseases with renal dysfunction
* Severe internal diseases
* Biochemical and/or hematological laboratory values beyond normal ranges unless the Investigator confirms that the deviations are of no clinical relevance
* Any indication of chronic use of drugs, alcohol, opiates or recreational drugs
* Use of any drug known to affect biotransformation of testosterone and/or progestin, e.g. chlorcycline, phenobarbital, phenylbutazone, aminophenazone within the 30 days preceding the first administration of the test medication and during the study
* Use of oral anticoagulatory drugs within the 30 days preceding the first administration of the test medication and during the study
* Any oral or transdermal hormone medication within the 12 weeks preceding the first administration and during the study
* Probability of poor compliance and termination of the study
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT04545450
Study Brief:
Protocol Section:
NCT04545450