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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00612742
Recruitment Status : Completed
First Posted : February 12, 2008
Last Update Posted : January 8, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Hypoactive Sexual Desire Disorder Drug: testosterone gel Drug: placebo gel Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3656 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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
Study Start Date : January 2008
Primary Completion Date : October 2012
Study Completion Date : December 2012


Arms and Interventions

Arm Intervention/treatment
Experimental: testosterone gel
1% testosterone transdermal gel
Drug: testosterone gel
once daily transdermal testosterone gel, 300 mcg
Other Name: LibiGel
Placebo Comparator: placebo gel
placebo transdermal gel
Drug: placebo gel
once daily transdermal placebo gel


Outcome Measures

Primary Outcome Measures :
  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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00612742


  Show 149 Study Locations
Sponsors and Collaborators
BioSante Pharmaceuticals
Investigators
Study Director: Michael C Snabes, MD, PhD BioSante Pharmaceuticals, Inc.
More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: BioSante Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00612742     History of Changes
Other Study ID Numbers: TESTW007
First Posted: February 12, 2008    Key Record Dates
Last Update Posted: January 8, 2013
Last Verified: January 2013

Keywords provided by BioSante Pharmaceuticals:
Cardiovascular event
Breast Cancer
Testosterone
Menopause
Hypoactive Sexual Desire Disorder

Additional relevant MeSH terms:
Disease
Hypokinesia
Sexual Dysfunctions, Psychological
Pathologic Processes
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Mental Disorders
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents