Pharmacokinetics, Pharmacodinamic and Safety of Testosterone Gel 1%

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Post-menopausal Period

Intervention / Treatment
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* 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%


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 42 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Testosterone gel 1% 2.2 mg<br>Testosterone gel 1% Topical use 2.2 mg (220 mg of gel) once daily duration of treatment: 28 days | Drug: Testosterone gel 1% 2.2 mg<br>* Application of 220 mg of Testosterone Gel 1% in pubic region, once daily, for 28 consecutive days.<br>|
| Experimental: Testosterone gel 1% 4.4 mg<br>Testosterone gel 1% Topical use 4.4 mg (440 mg of gel) once daily duration of treatment: 28 days | Drug: Testosterone gel 1% 4.4 mg<br>* Application of 440 mg of Testosterone Gel 1% in pubic region, once daily, for 28 consecutive days.<br>|
| Experimental: Testosterone gel 1% 8.8 mg<br>Testosterone gel 1% Topical use 8.8 mg (880 mg of gel) once daily duration of treatment: 28 days | Drug: Testosterone gel 1% 8.8 mg<br>* Application of 880 mg of Testosterone Gel 1% in pubic region, once daily, for 28 consecutive days.<br>|
| Placebo Comparator: Placebo of Testosterone Gel 1%<br>Placebo of Testosterone Gel 1% Topical use Approximately 550 mg of gel Once daily duration of treatment: 28 days | Drug: Placebo of Testosterone Gel 1%<br>* Application of approximately 550 mg of Placebo of Testosterone Gel 1% in pubic region, once daily, for 28 consecutive days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacodynamics, response rate, by Female Sexual Function Index |  | 28 days | 
| Safety, number of adverse events |  | 28 days |