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Completed

NCT Number: NCT00612742

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

This study is a randomized, double-blind, placebo-controlled, adaptive design, multi-center study of the long-term cardiovascular and breast safety of LibiGel in the treatment of HSDD in postmenopausal women with at least two points of cardiovascular risk and clinical diagnosis of Hypoactive Sexual Desire Disorder (HSDD).

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Key information

Conditions

Hypoactive Sexual Desire Disorder Breast Diseases Breast Neoplasms Mental Disorders Neoplasms Neoplasms by Site Sexual Dysfunctions, Psychological Skin Diseases Skin and Connective Tissue Diseases

Age range

50 year and older

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

Postmenopausal female subjects

  • at least 50 years of age
  • with at least two points of cardiovascular risk
  • with a clinical diagnosis of HSDD.

Exclusion criteria

Subjects must not

  • require treatment with anti-androgens, high-dose oral or injectable corticosteroids, tamoxifen or other selective estrogen receptor modulators,
  • have used androgen therapy within 2 months of randomization,
  • have a history of estrogen-dependent neoplasia or any gynecologic cancer,
  • have a history of cancer of any kind in the past 10 years prior to randomization,
  • have a history of malignant melanoma or a history of invasive cancer at any time,
  • have a screening mammogram with any finding that requires follow up within 6 months of randomization,
  • have a history of myocardial infarction, coronary revascularization or stroke within 12 months of randomization,
  • have any medical condition associated with predicted survival of less than 3 years in the judgment of the Investigator.

Treatment and study plan

Testosterone gel

Drug

once daily transdermal testosterone gel, 300 mcg

Other names: LibiGel

Placebo Gel

Drug

once daily transdermal placebo gel

Primary outcomes

  1. The rate of adjudicated, predefined cardiovascular events in LibiGel-treated subjects compared to that of placebo-treated subjects.

    Time frame: 2011 primary outcome analysis for NDA submission

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 Long-Term Safety and Efficacy of LibiGel® for the Treatment of Hypoactive Sexual Desire Disorder in Postmenopausal Women

Acronym: BLOOM

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Feb 12, 2008
Registry last updated
Oct 29, 2021

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.

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