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 @ 4:18 AM
Ignite Modification Date:
2025-12-25 @ 4:18 AM
NCT ID:
NCT01538420
Eligibility Criteria:
Inclusion Criteria:
* Healthy male, age 18-50 years (for part 1), and postmenopausal subjects age 35-65 years (for part 2)
* Body mass index (BMI) between 18-30 kg/m², inclusive.
* For men: normal values of testosterone (175-781 ng/dL) and LH (1.24-8.62 U/L).
* Women must be postmenopausal for at least 2 years with postmenopausal FSH level according to the local lab (+negative pregnancy test at screening \& admission).
Exclusion Criteria:
* smoking
* drug or alcohol abuse
* hypersensitivity to any of the ingredients of the study drug
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01538420
Study Brief:
Protocol Section:
NCT01538420