Pharmacokinetics, Pharmacodinamic and Safety of Testosterone Gel 1%
Phase 1
Withdrawn
- Conditions
- Post-menopausal Period
- Interventions
- Drug: Placebo of Testosterone Gel 1%
- Registration Number
- NCT02667561
- Lead Sponsor
- Biolab Sanus Farmaceutica
- Brief 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
- Detailed Description
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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- Female
- Target Recruitment
- Not specified
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Testosterone gel 1% 2.2 mg Testosterone gel 1% 2.2 mg Testosterone gel 1% Topical use 2.2 mg (220 mg of gel) once daily duration of treatment: 28 days Testosterone gel 1% 4.4 mg Testosterone gel 1% 4.4 mg Testosterone gel 1% Topical use 4.4 mg (440 mg of gel) once daily duration of treatment: 28 days Testosterone gel 1% 8.8 mg Testosterone gel 1% 8.8 mg Testosterone gel 1% Topical use 8.8 mg (880 mg of gel) once daily duration of treatment: 28 days Placebo of Testosterone Gel 1% Placebo of Testosterone Gel 1% Placebo of Testosterone Gel 1% Topical use Approximately 550 mg of gel Once daily duration of treatment: 28 days
- Primary Outcome Measures
Name Time Method Pharmacokinetics, area under the curve (AUC) 28 days Pharmacokinetics, maximum concentration (Cmax) 28 days Pharmacokinetics, time to maximum concentration (Tmax) 28 days Pharmacokinetics, half-life (t1/2) 28 days
- Secondary Outcome Measures
Name Time Method Pharmacodynamics, response rate, by Female Sexual Function Index 28 days Safety, number of adverse events 28 days