Pharmacokinetics, Pharmacodinamic and Safety of Testosterone Gel 1%

• Status: Withdrawn
• Trial end date: 2018-05-01
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Biolab Sanus Farmaceutica
• Treatments: Methyltestosterone; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate

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.