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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
BioSante Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00612742
First received: January 23, 2008
Last updated: January 4, 2013
Last verified: January 2013
  Purpose

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 Intervention Phase
Hypoactive Sexual Desire Disorder
Drug: testosterone gel
Drug: placebo gel
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by BioSante Pharmaceuticals:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 3656
Study Start Date: January 2008
Study Completion Date: December 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: placebo gel

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00612742

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

No publications provided by BioSante Pharmaceuticals

Additional 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
Study First Received: January 23, 2008
Last Updated: January 4, 2013
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

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

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

ClinicalTrials.gov processed this record on July 22, 2014