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Bioequivalence of Testosterone Reduced-size Patch Relative to the Testosterone Reference Patch

NCT00791856 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2013-04-17

No results posted yet for this study

Summary

This is an open-label, multiple-dose, randomized, two-period crossover bioequivalence study in approximately 110 surgically or naturally postmenopausal women on stable hormone therapy (i.e., estrogen for surgically postmenopausal women or a continuous regimen of estrogen plus progestin for naturally postmenopausal women) restricted to approved oral or transdermal regimens only, or not on concomitant hormone therapy.

Conditions

  • Healthy

Interventions

DRUG

testosterone

28 cm2 testosterone patch, each patch is on for 4 days, 3 patches are used

DRUG

testosterone

14 cm2 testosterone patch, each patch is on for 4 days, 3 patches are used

Sponsors & Collaborators

  • Warner Chilcott

    lead INDUSTRY

Principal Investigators

  • Angela X Qu, MD, MS · Procter and Gamble

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2008-05-31
Completion
2008-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00791856 on ClinicalTrials.gov