Study of Serum Testosterone Levels in Non-dosed Females After Secondary Exposure

Phase 1

Completed

• Conditions: Hypogonadism
• Interventions: Drug: Testosterone gel 1.62%

• Registration Number: NCT00998933
• Lead Sponsor: Solvay Pharmaceuticals

Brief Summary

To further characterize the transfer potential of marketed testosterone gel and new 1.62% formulation.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Primary Completion: 2009-10
• Study Completion: 2009-10
• Study First Submitted: 2009-10-20
• Study First Submitted QC: 2009-10-20
• Study First Posted: 2009-10-21
• Status Verified: 2009-11
• Last Update Submitted: 2009-11-24
• Last Update Posted: 2009-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Healthy male and female volunteers, with a BMI 20-35 kg/m2 (males) and 20-30 kg/m2 (females).

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Exclusion Criteria

• Males: history, current or suspected prostate or breast cancer.
• Female: pregnant or lactating.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Testosterone gel 1.62%	-

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic Parameters Total Testosterone AUC, Cav, Cmax	4 days

Trial Locations

Locations (1)

Site 1; 🇺🇸 Miami Gardens, Florida, United States