Pharmacokinetics, Pharmacodinamic and Safety of Testosterone Gel 1%

Biolab Pharma

Status and phase: Withdrawn; Phase 1

Conditions: Post-menopausal Period

Treatments: Drug: Testosterone gel 1% 2.2 mg; Drug: Testosterone gel 1% 8.8 mg; Drug: Placebo of Testosterone Gel 1%; Drug: Testosterone gel 1% 4.4 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02667561

GDN 060/15

Details and patient eligibility

About

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

Full 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.

Sex: Female

Ages: 42 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 4 patient groups, including a placebo group

Testosterone gel 1% 2.2 mg

Experimental group

Description:

Testosterone gel 1% Topical use 2.2 mg (220 mg of gel) once daily duration of treatment: 28 days

Treatment:

Drug: Testosterone gel 1% 2.2 mg

Testosterone gel 1% 4.4 mg

Experimental group

Description:

Testosterone gel 1% Topical use 4.4 mg (440 mg of gel) once daily duration of treatment: 28 days

Treatment:

Drug: Testosterone gel 1% 4.4 mg

Testosterone gel 1% 8.8 mg

Experimental group

Description:

Testosterone gel 1% Topical use 8.8 mg (880 mg of gel) once daily duration of treatment: 28 days

Treatment:

Drug: Testosterone gel 1% 8.8 mg

Placebo of Testosterone Gel 1%

Placebo Comparator group

Description:

Placebo of Testosterone Gel 1% Topical use Approximately 550 mg of gel Once daily duration of treatment: 28 days

Treatment:

Drug: Placebo of Testosterone Gel 1%