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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00969163
Recruitment Status : Completed
First Posted : September 1, 2009
Last Update Posted : September 4, 2014
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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.

Condition or disease Intervention/treatment Phase
Skin Androgenization Drug: testosterone gel Drug: Comparator: placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Diagnostic
Official Title: A Pilot Study to Investigate Biomarkers of Skin Androgenization Following Short-Term Testosterone Administration in Healthy Postmenopausal Women
Study Start Date : October 2004
Actual Primary Completion Date : April 2005
Actual Study Completion Date : June 2005

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. serum free testosterone concentrations following multiple doses of AndroGel [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. mean percent change from baseline in sebum excretion [ Time Frame: 6 weeks ]


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Ages Eligible for Study:   50 Years to 65 Years   (Adult, Older Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00969163


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
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Study Director: Medical Monitor Merck Sharp & Dohme Corp.

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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00969163     History of Changes
Other Study ID Numbers: 0000-015
MK0000-015
2009_654
First Posted: September 1, 2009    Key Record Dates
Last Update Posted: September 4, 2014
Last Verified: September 2014
Keywords provided by Merck Sharp & Dohme Corp.:
Biomarkers of Skin Androgenization
Additional relevant MeSH terms:
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Virilism
Signs and Symptoms
Methyltestosterone
Testosterone
Testosterone undecanoate
Testosterone enanthate
Testosterone 17 beta-cypionate
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents