A Study to Investigate Biomarkers of Skin Androgenization Following Testosterone Administration (0000-015)(COMPLETED).
Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Skin Androgenization
Intervention: testosterone gel (Drug); Comparator: placebo (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Merck Sharp & Dohme Corp. Official(s) and/or principal investigator(s): Medical Monitor, Study Director, Affiliation: Merck Sharp & Dohme Corp.
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.
Clinical Details
Official title: A Pilot Study to Investigate Biomarkers of Skin Androgenization Following Short-Term Testosterone Administration in Healthy Postmenopausal Women
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Diagnostic
Primary outcome: serum free testosterone concentrations following multiple doses of AndroGel
Secondary outcome: mean percent change from baseline in sebum excretion
Eligibility
Minimum age: 50 Years.
Maximum age: 65 Years.
Gender(s): Female.
Criteria:
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
Locations and Contacts
Additional Information
Starting date: October 2004
Last updated: September 3, 2014
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