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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.


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


Minimum age: 50 Years. Maximum age: 65 Years. Gender(s): Female.


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

Page last updated: August 23, 2015

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