Extension Study to Assess Persistence of Benefit of LibiGel for the Treatment of Hypoactive Sexual Desire Disorder (HSDD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
BioSante Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01235754
First received: November 4, 2010
Last updated: January 4, 2013
Last verified: January 2013
  Purpose

The objective of this study is to evaluate the persistence of benefit of LibiGel (testosterone gel) 300 mcg/day compared to placebo gel in a 12 week post-treatment period of Hypoactive Sexual Desire Disorder (HSDD) in surgically menopausal women.


Condition Intervention Phase
Hypoactive Sexual Desire Disorder
Drug: transdermal testosterone gel 1%
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, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase III, Multi-Center Extension Study to Assess Persistence of Benefit of LibiGel for the Treatment of Hypoactive Sexual Desire Disorder (HSDD) in Surgically Menopausal Women

Resource links provided by NLM:


Further study details as provided by BioSante Pharmaceuticals:

Primary Outcome Measures:
  • Change in the 4-week total number of days with at least one satisfying sexual event from the baseline period (during the previous study) to weeks 9-12 of the current study [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    This study is to assess the persistence of benefit following the withdrawal of testosterone gel (LibiGel) in the treatment of Hypoactive Sexual Desire Disorder (HSDD) in healthy, surgically menopausal women.


Secondary Outcome Measures:
  • change from baseline (previous study) in the mean FSDS-R question 13 score to week 12 of the current study [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    This study is to acess the persistence of benefit following the withdrawal of testosterone gel 1% (LibiGel)in the treatment of Hypoactive Sexual Desire Disorder (HSDD) in healthy, surgically menopausal women.

  • change from baseline (previous study) in the total number of days with at least one satisfying sexual event at weeks 4 and 8 of the current study [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    This study is to assess the persistence of benefit following the withdrawal of testosterone gel (LibiGel)in the treatment of Hypoactive Sexual Desire Disorder (HSDD) in healthy, surgically menopausal women.


Enrollment: 626
Study Start Date: October 2010
Study Completion Date: January 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: placebo gel
placebo transdermal gel
Drug: placebo gel
once daily transdermal placebo gel
Other Name: transdermal placebo gel
Experimental: testosterone gel
transdermal testosterone gel
Drug: transdermal testosterone gel 1%
300 mcg once daily transdermal testosterone gel 1%
Other Name: LibiGel transdermal testosterone gel 1%

  Eligibility

Ages Eligible for Study:   30 Years to 66 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • must have completed a minimum of 22 weeks of the 24-week TESTW006 or TESTW008 clinical trial

Exclusion Criteria:

  • Any condition (including a change in sexual or relationship history) that would make the subject unsuitable for participation in the trial in the opinion 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: NCT01235754

  Show 102 Study Locations
Sponsors and Collaborators
BioSante Pharmaceuticals
Investigators
Study Director: Michael C Snabes, MD, PhD BioSante Pharmaceuticals
  More Information

No publications provided

Responsible Party: BioSante Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01235754     History of Changes
Other Study ID Numbers: TESTW009
Study First Received: November 4, 2010
Last Updated: January 4, 2013
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by BioSante Pharmaceuticals:
testosterone
hypoactive sexual desire disorder
menopause

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 24, 2014