Post-menopausal Period
Conditions
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.
Interventions
DRUGTestosterone gel 1% 8.8 mg
Application of 880 mg of Testosterone Gel 1% in pubic region, once daily, for 28 consecutive days.
DRUGPlacebo of Testosterone Gel 1%
Application of approximately 550 mg of Placebo of Testosterone Gel 1% in pubic region, once daily, for 28 consecutive days.
DRUGTestosterone gel 1% 2.2 mg
Application of 220 mg of Testosterone Gel 1% in pubic region, once daily, for 28 consecutive days.
DRUGTestosterone gel 1% 4.4 mg
Application of 440 mg of Testosterone Gel 1% in pubic region, once daily, for 28 consecutive days.
Sponsors
Biolab Sanus Farmaceutica
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
42 Years to 65 Years
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.
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| Safety, number of adverse events | 28 days |
| Pharmacodynamics, response rate, by Female Sexual Function Index | 28 days |
Outcome results
None listed