The Efficacy, Safety And Toleration Of CP-866,087 In Pre-Menopausal Women With Female Sexual Arousal Disorder.

Phase 2

Completed

• Conditions: Sexual Dysfunction, Physiological
• Interventions: Drug: CP-866,087; Drug: Placebo

• Registration Number: NCT00482664
• Lead Sponsor: Pfizer

Brief Summary

CP-866,087 is a non-hormonal compound, acting on the central nervous system, which has been shown in animal models to restore sexual function.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-06-01
• Study First Submitted QC: 2007-06-01
• Study First Posted: 2007-06-05
• Study Start: 2007-07
• Primary Completion: 2008-09
• Study Completion: 2008-10
• Disposition First Submitted: 2009-03-24
• Status Verified: 2010-10
• Disposition First Submitted QC: 2010-10-27
• Last Update Submitted: 2010-10-27
• Disposition First Posted: 2010-11-01
• Last Update Posted: 2010-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 84

Inclusion Criteria

• healthy pre-menopausal women
• primary female sexual arousal disorder causing distress
• on stable use of oral contraceptives

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Exclusion Criteria

• any other significant disease causing Female Sexual Dysfunction including psychiatric disease
• subjects on drugs known to cause Female Sexual Dysfunction
• subjects who have given birth in the last 12 months or who are planning to become pregnant during the study

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1 mg	CP-866,087	-
10 mg	CP-866,087	-
3 mg	CP-866,087	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Diary events, including Satisfactory Sexual Experiences (SSEs) over 6 weeks.	6 weeks
Score in Abbreviated Sexual Function Questionnaire after 6 weeks of treatment.	6 weeks

Secondary Outcome Measures

Name	Time	Method
Exit interview at end of study. Meaningful Benefit Question at end of study.	End of study
Measure of Female Sexual Distress questionnaire after 6 weeks of treatment.	6 weeks

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇸🇪 Stockholm, Sweden