Skip to main content
OpenTrials
Completed

NCT Number: NCT00657501

Safety and Efficacy of LibiGel® for Treatment of Hypoactive Sexual Desire Disorder in Surgically Menopausal Women

This study is a randomized, double-blind, placebo-controlled, multi-center study of the safety and efficacy of LibiGel 300mcg in the treatment of HSDD in surgically menopausal women.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hypoactive Sexual Desire Disorder Mental Disorders Sexual Dysfunctions, Psychological

Age range

30 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

BioSante Site #175, Vancouver, British Columbia, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Must be between the ages of 30 to 65 years
  • Must have undergone hysterectomy and bilateral salpingo-oophorectomy

Exclusion criteria

  • A history of allergic reactions to androgens (oral or patch), topical alcohol, or any component of the formulation
  • Any systemic skin diseases or local skin abnormalities in the area of application
  • Diagnosed with another primary female sexual dysfunction (e.g., Sexual Aversion Disorder, Female Sexual Arousal Disorder).
  • A medical condition that could affect or interfere with sexual function
  • Using a systemic transdermal gel or cream estrogen therapy.

Treatment and study plan

Testosterone gel

Drug

once daily transdermal gel, 300 mcg

Other names: LibiGel

Placebo Gel

Drug

once daily transdermal placebo gel

Primary outcomes

  1. Co-primary endpoints are the change in the 4-week total number of satisfying sexual events from the Baseline period to Weeks 21-24, and the change from Baseline to Weeks 21-24 in the mean ISED desire score.

    Time frame: Time Frame: Baseline and 21-24 weeks.

Secondary outcomes

  1. Change from baseline over time for multiple efficacy measurements

    Time frame: change over timepoints from baseline period

Sponsors and collaborators

Lead sponsor

BioSante Pharmaceuticals

Industry

Registry information

Official study title

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of the Safety and Efficacy of LibiGel® for the Treatment of Hypoactive Sexual Desire Disorder in Surgically Menopausal Women

Acronym: BLOOM

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Apr 14, 2008
Registry last updated
Jan 10, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.