Pharmacokinetics, Pharmacodinamic and Safety of Testosterone Gel 1%

Phase I Clinical Trial for Evaluation of Pharmacokinetics, Pharmacodynamics and Safety of Testosterone Gel 1% for Topical Use, After Administration of Three Different Doses (2.2 mg, 4.4 mg, 8.8 mg and Placebo) for 28 Consecutive Days in Post-menopausal Women.

This is a Phase I, open-label, parallel trial to evaluate Pharmacokinetics, Pharmacodynamics and Safety of Testosterone gel 1% for topic usage in post-menopausal women, for 28 days

This is a Phase I, open-label, parallel trial to evaluate Pharmacokinetics, Pharmacodynamics and Safety of Testosterone gel 1% for topic usage in post-menopausal women, Study participants will receive investigational product for 28 consecutive days, once daily, as per the following allocation: 2.2 mg, 4.4 mg. 8.8 mg or placebo.

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.