Evaluate the Safety and Efficacy of Bremelanotide in Women With Female Sexual Arousal Disorder (FSAD)

This study has been completed.

Sponsor:

Collaborator:

King Pharmaceuticals is now a wholly owned subsidiary of Pfizer

Information provided by:

Palatin Technologies

ClinicalTrials.gov Identifier:

NCT00425256

First received: January 18, 2007

Last updated: February 22, 2011

Last verified: February 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	January 18, 2007
Last Updated Date	February 22, 2011
Start Date ^ICMJE	February 2006
Primary Completion Date	May 2007 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00425256 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Evaluate the Safety and Efficacy of Bremelanotide in Women With Female Sexual Arousal Disorder (FSAD)
Official Title ^ICMJE	Not Provided
Brief Summary	This 8 week at home study is designed to explore efficacy endpoints and evaluate the safety of intranasal Bremelanotide in women with Female Sexual Arousal Disorder. Efficacy will be assessed vs. a parallel placebo group.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double-Blind
Condition ^ICMJE	Sexual Arousal Disorder
Intervention ^ICMJE	Drug: Bremelanotide
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	Not Provided
Completion Date	May 2007
Primary Completion Date	May 2007 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Post menopausal and in general good health In a stable relationship with a male partner for at least 6 months Willing to attempt sexual activity once a week with your partner
Gender	Female
Ages	21 Years to 70 Years
Accepts Healthy Volunteers	Not Provided
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00425256
Other Study ID Numbers ^ICMJE	PT-141-2005-53
Has Data Monitoring Committee	Not Provided
Responsible Party	Robert Jordan, Palatin Technologies, Inc.
Study Sponsor ^ICMJE	Palatin Technologies
Collaborators ^ICMJE	King Pharmaceuticals is now a wholly owned subsidiary of Pfizer
Investigators ^ICMJE	Not Provided
Information Provided By	Palatin Technologies
Verification Date	February 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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