Pharmacokinetics, Pharmacodinamic and Safety of Testosterone Gel 1%

Phase 1

Withdrawn

• Conditions: Post-menopausal Period
• Interventions: Drug: Testosterone gel 1% 2.2 mg; Drug: Testosterone gel 1% 4.4 mg; Drug: Testosterone gel 1% 8.8 mg; 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.

Study Timeline

• Study First Submitted: 2016-01-26
• Study First Submitted QC: 2016-01-26
• Study First Posted: 2016-01-29
• Study Start: 2017-07
• Status Verified: 2017-09
• Primary Completion: 2017-12
• Study Completion: 2018-05
• Last Update Submitted: 2018-06-04
• Last Update Posted: 2018-06-06

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• Status: WITHDRAWN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