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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Study Completion Date

2005-06-30

Brief Summary

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

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Detailed Description

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Conditions

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Skin Androgenization

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

2.5 mg testosterone gel

Group Type EXPERIMENTAL

testosterone gel

Intervention Type DRUG

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

2

300 ug testosterone gel

Group Type EXPERIMENTAL

testosterone gel

Intervention Type DRUG

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

3

placebo gel

Group Type PLACEBO_COMPARATOR

Comparator: placebo

Intervention Type DRUG

transdermal placebo gel for 6 weeks

Interventions

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testosterone gel

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

Intervention Type DRUG

Comparator: placebo

transdermal placebo gel for 6 weeks

Intervention Type DRUG

Other Intervention Names

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AndroGel

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes