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 @ 12:07 PM
Ignite Modification Date:
2025-12-24 @ 12:07 PM
NCT ID:
NCT02667561
Eligibility Criteria:
Inclusion Criteria:
* Female subjects aged ≥ 42 years and ≤ 65 years, in post-menopausal period for at least 1 year and with active sexual life;
* Serum testosterone levels \< 33 ng/mL;
* Follicle-stimulating hormone (FSH) levels \> 22 mU/mL;
* Absence of other significant diseases which, at the physician's discretion, could impact subject's participation in the trial, according to protocol requirements, and study evaluations: medical history, blood pressure and heart rate measurements, physical examination and complimentary laboratory tests;
* Ability to understand the nature and objective of the trial, including risks and adverse events, which shall be confirmed by Informed Consent Form signature.
Exclusion Criteria:
* Screening laboratory tests results presenting clinically relevant deviations that, at the investigator discretion, prevent the subject to participate in the trial due to possible risks;
* Drugs addiction, including alcohol;
* Treatment with any drugs known to have a well-established toxic potential to major organs, within 3 months before the trial, ;
* Participation in any other experimental research or administration of any experimental drug within six months before the initiation of this trial;
* Pregnancy, labor or miscarriage in the last 12 weeks before the antecipated date of the study treatment start;
* Any conditions, according to investigator's best judgement, that prevents the subject to participate in the trial.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
42 Years
Maximum Age:
65 Years
Study:
NCT02667561
Study Brief:
Protocol Section:
NCT02667561