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Pharmacokinetics, Pharmacodinamic and Safety of Testosterone Gel 1%

NCT02667561 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2018-06-06

No results posted yet for this study

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

Conditions

  • Post-menopausal Period

Interventions

DRUG

Testosterone gel 1% 2.2 mg

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

DRUG

Testosterone gel 1% 4.4 mg

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

DRUG

Testosterone gel 1% 8.8 mg

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

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.

Sponsors & Collaborators

  • Biolab Sanus Farmaceutica

    lead INDUSTRY

Principal Investigators

  • Gilberto De Nucci, PhD · Galeno Desenvolvimento de Pesquisas

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
42 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-07-31
Primary Completion
2017-12-31
Completion
2018-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02667561 on ClinicalTrials.gov