Viewing Study NCT00144391



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Last Modification Date: 2024-10-26 @ 9:14 AM
Study NCT ID: NCT00144391
Status: COMPLETED
Last Update Posted: 2017-06-27
First Post: 2005-09-01

Brief Title: Testosterone Gel Applied to Women With Pituitary Gland Problems
Sponsor: Charles Drew University of Medicine and Science
Organization: Charles Drew University of Medicine and Science

Study Overview

Official Title: Physiologic Testosterone Replacement in Women With Hypopituitarism
Status: COMPLETED
Status Verified Date: 2017-04
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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
Detailed Description: Testosterone is the principal male sex hormone but is also present in smaller amounts in women and may be important for their health Among its likely actions in women are the building of bone and muscle mass increase in interest in sex libido and effects on the mood Testosterone is commercially available as a hormone replacement therapy for males with an absence or lack of testosterone production Testosterone for males is mainly given in the form of shots or skin patches which have certain disadvantages such as pain from shots and skin rashes from patches It is anticipated that this experimental gel application will produce levels of the drug in the normal range in women

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
1U54HD041748-01 NIH None httpsreporternihgovquickSearch1U54HD041748-01