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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Skin Androgenization

Treatments: Drug: Comparator: placebo; Drug: testosterone gel

Study type: Interventional

Funder types: Industry

Identifiers

NCT00969163

MK0000-015

0000-015

2009_654

Details and patient eligibility

About

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

Enrollment: 30 patients

Sex: Female

Ages: 50 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 3 patient groups, including a placebo group

1

Experimental group

Description:

2.5 mg testosterone gel

Treatment:

Drug: testosterone gel

2

Experimental group

Description:

300 ug testosterone gel

Treatment:

Drug: testosterone gel

3

Placebo Comparator group

Description:

placebo gel

Treatment:

Drug: Comparator: placebo