Skin Androgenization
Conditions
Keywords
Biomarkers of Skin Androgenization
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.
Interventions
DRUGtestosterone gel
300 ug or 2.5 mg transdermal testosterone gel daily for 6 weeks
DRUGComparator: placebo
transdermal placebo gel for 6 weeks
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
50 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| serum free testosterone concentrations following multiple doses of AndroGel | 6 weeks |
Secondary
| Measure | Time frame |
|---|---|
| mean percent change from baseline in sebum excretion | 6 weeks |
Outcome results
None listed