NCT02667561

Pharmacokinetics, Pharmacodinamic and Safety of Testosterone Gel 1%

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.

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Biolab Sanus Farmaceutica · Industry
• Sex: Female
• Age: 42 Years – 65 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-07-01
• Primary completion: 2017-12-01
• Completion: 2018-05-01
• First posted: 2016-01-29
• Last updated: 2018-06-06