Skip to main content
OpenTrials
Completed

NCT Number: NCT00969163

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Skin Androgenization

Age range

50 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Testosterone gel

Drug

300 ug or 2.5 mg transdermal testosterone gel daily for 6 weeks

Other names: AndroGel

Comparator: placebo

Drug

transdermal placebo gel for 6 weeks

Primary outcomes

  1. serum free testosterone concentrations following multiple doses of AndroGel

    Time frame: 6 weeks

Secondary outcomes

  1. mean percent change from baseline in sebum excretion

    Time frame: 6 weeks

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Pilot Study to Investigate Biomarkers of Skin Androgenization Following Short-Term Testosterone Administration in Healthy Postmenopausal Women

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Sep 1, 2009
Registry last updated
Sep 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.