Clinical trial NCT02667561: Pharmacokinetics, Pharmacodinamic and Safety of Testosterone Gel 1%
Official title: 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.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Post-menopausal Period
Lead sponsor: Biolab Sanus Farmaceutica
Sponsor class: INDUSTRY
First posted: 2016-01-29
Enrollment: 0
Sex: FEMALE
Minimum age (years): 42
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility 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.

Primary outcomes:
measure: Pharmacokinetics, area under the curve (AUC)
timeFrame: 28 days
measure: Pharmacokinetics, maximum concentration (Cmax)
timeFrame: 28 days
measure: Pharmacokinetics, time to maximum concentration (Tmax)
timeFrame: 28 days
measure: Pharmacokinetics, half-life (t1/2)
timeFrame: 28 days
Secondary outcomes:
measure: Pharmacodynamics, response rate, by Female Sexual Function Index
timeFrame: 28 days
measure: Safety, number of adverse events
timeFrame: 28 days
Other outcomes:
Locations:
Study officials:
affiliation: Galeno Desenvolvimento de Pesquisas
name: Gilberto De Nucci, PhD
role: PRINCIPAL_INVESTIGATOR
References: