A Study to Investigate Biomarkers of Skin Androgenization Following Testosterone Administration (0000-015)(COMPLETED).

Phase 1

Completed

• Conditions: Skin Androgenization
• Interventions: Drug: testosterone gel

• Registration Number: NCT00969163
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

Postmenopausal women will receive testosterone gel or matching placebo gel daily. Sebum excretion rates will be measured before and after 6 weeks of treatment.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-10
• Primary Completion: 2005-04
• Study Completion: 2005-06
• Study First Submitted: 2009-08-31
• Study First Submitted QC: 2009-08-31
• Study First Posted: 2009-09-01
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-03
• Last Update Posted: 2014-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

• Subject is at least 3 years postmenopausal
• Subject is in good general health
• Subject is willing to avoid excess alcohol or strenuous physical activity during the study

Exclusion Criteria

• Subject has donated a unit of blood or has taken an investigational drug in another clinical trial in the last 4 weeks
• Subject is a regular user of any illicit drugs
• Subject drinks excessive amounts of coffee, tea or cola
• Subject has used an estrogen or progestogens hormone replacement therapy in the past 6 months
• Subject has a history of cancer
• Subject has acne

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	testosterone gel	300 ug testosterone gel
1	testosterone gel	2.5 mg testosterone gel

Primary Outcome Measures

Name	Time	Method
serum free testosterone concentrations following multiple doses of AndroGel	6 weeks

Secondary Outcome Measures

Name	Time	Method
mean percent change from baseline in sebum excretion	6 weeks