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A Study to Investigate Biomarkers of Skin Androgenization Following Testosterone Administration

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00969163
First received: August 31, 2009
Last updated: NA
Last verified: August 2009
History: No changes posted
  Purpose

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


Condition Intervention Phase
Skin Androgenization
 Drug: testosterone gel
Drug: Comparator: placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Diagnostic
Official Title: A Pilot Study to Investigate Biomarkers of Skin Androgenization Following Short-Term Testosterone Administration in Healthy Postmenopausal Women

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • serum free testosterone concentrations following multiple doses of AndroGel [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • mean percent change from baseline in sebum excretion [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: October 2004
Study Completion Date: June 2005
Primary Completion Date: April 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
2.5 mg testosterone gel
 Drug: testosterone gel
300 ug or 2.5 mg transdermal testosterone gel daily for 6 weeks
Other Name: AndroGel
Experimental: 2
300 ug testosterone gel
 Drug: testosterone gel
300 ug or 2.5 mg transdermal testosterone gel daily for 6 weeks
Other Name: AndroGel
Placebo Comparator: 3
placebo gel
 Drug: Comparator: placebo
transdermal placebo gel for 6 weeks

  Eligibility

Ages Eligible for Study:   50 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00969163

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

No publications provided

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier: NCT00969163     History of Changes
Other Study ID Numbers: 2009_654, MK0000-015
Study First Received: August 31, 2009
Last Updated: August 31, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck:
Biomarkers of Skin Androgenization

Additional relevant MeSH terms:
Virilism
Signs and Symptoms
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Androgens
 Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents

ClinicalTrials.gov processed this record on June 17, 2013