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Testosterone Gel Applied to Women With Pituitary Gland Problems

NCT00144391 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2017-06-27

Study results available
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Summary

The principal aim of this study is to evaluate if application of testosterone gel leads to improvement in measures of sexual function, thinking ability and quality of life in women with dysfunction of the pituitary gland. A secondary purpose is to determine the effects of testosterone replacement on body composition and muscle function and strength.

Conditions

  • Panhypopituitarism

Interventions

DRUG

Transdermal Testosterone gel

2.0 mg per pump of transdermal testosterone gel. Study patients receive either 2 pumps of transdermal testosterone gel per thigh per day or they receive 2 pumps per placebo gel per thigh per day for 6 months.

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • Charles Drew University of Medicine and Science

    lead OTHER

Principal Investigators

  • Theodore C Friedman, M.D., Ph.D. · Charles Drew University of Medicine and Science

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2003-07-31
Primary Completion
2010-12-31
Completion
2010-12-31

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 NCT00144391 on ClinicalTrials.gov