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.
Trial Snapshot
- Phase
- Phase 1
- Status
- Withdrawn
- Sponsor
- Primary Endpoint
- Pharmacokinetics, area under the curve (AUC)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 42 Years to 65 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
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
Intervention: Testosterone gel 1% 2.2 mg (Drug)
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
Intervention: Testosterone gel 1% 4.4 mg (Drug)
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
Intervention: Testosterone gel 1% 8.8 mg (Drug)
Placebo of Testosterone Gel 1%
Placebo of Testosterone Gel 1% Topical use Approximately 550 mg of gel Once daily duration of treatment: 28 days
Intervention: Placebo of Testosterone Gel 1% (Drug)
Outcomes
Primary Outcomes
Pharmacokinetics, area under the curve (AUC)
Time Frame: 28 days
Pharmacokinetics, maximum concentration (Cmax)
Time Frame: 28 days
Pharmacokinetics, time to maximum concentration (Tmax)
Time Frame: 28 days
Pharmacokinetics, half-life (t1/2)
Time Frame: 28 days
Secondary Outcomes
- Pharmacodynamics, response rate, by Female Sexual Function Index(28 days)
- Safety, number of adverse events(28 days)