Pharmacokinetics, Pharmacodinamic and Safety of Testosterone Gel 1%

NCT ID: NCT02667561

Last Updated: 2018-06-06

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-31
• Study Completion Date: 2018-05-31

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.

Conditions

Post-menopausal Period

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Testosterone gel 1% 2.2 mg

Intervention Type: DRUG

Application of 220 mg of Testosterone Gel 1% in pubic region, once daily, for 28 consecutive days.

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

Group Type: EXPERIMENTAL

Testosterone gel 1% 4.4 mg

Intervention Type: DRUG

Application of 440 mg of Testosterone Gel 1% in pubic region, once daily, for 28 consecutive days.

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

Group Type: EXPERIMENTAL

Testosterone gel 1% 8.8 mg

Intervention Type: DRUG

Application of 880 mg of Testosterone Gel 1% in pubic region, once daily, for 28 consecutive days.

Placebo of Testosterone Gel 1%

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

Group Type: PLACEBO_COMPARATOR

Placebo of Testosterone Gel 1%

Intervention Type: DRUG

Application of approximately 550 mg of Placebo of Testosterone Gel 1% in pubic region, once daily, for 28 consecutive days.

Interventions

Testosterone gel 1% 2.2 mg

Application of 220 mg of Testosterone Gel 1% in pubic region, once daily, for 28 consecutive days.

Intervention Type: DRUG

Testosterone gel 1% 4.4 mg

Application of 440 mg of Testosterone Gel 1% in pubic region, once daily, for 28 consecutive days.

Intervention Type: DRUG

Testosterone gel 1% 8.8 mg

Application of 880 mg of Testosterone Gel 1% in pubic region, once daily, for 28 consecutive days.

Intervention Type: DRUG

Placebo of Testosterone Gel 1%

Application of approximately 550 mg of Placebo of Testosterone Gel 1% in pubic region, once daily, for 28 consecutive days.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 42 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Biolab Sanus Farmaceutica

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gilberto De Nucci, PhD

Role: PRINCIPAL_INVESTIGATOR

Galeno Desenvolvimento de Pesquisas

Other Identifiers

GDN 060/15

Identifier Type: -

Identifier Source: org_study_id