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

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00482664

Purpose

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.

Condition	Intervention	Phase
Sexual Dysfunction, Physiological	Drug: CP-866,087 Drug: Placebo	Phase II

MedlinePlus related topics: Menopause

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Crossover Assignment, Safety/Efficacy Study
Official Title:	A Phase 2a Multi-Centre, Double Blind, Placebo Controlled Cross-Over Trial To Investigate The Efficacy, Safety And Toleration Of CP-866,087 In Pre-Menopausal Women Diagnosed With Female Sexual Arousal Disorder (FSAD).

Further study details as provided by Pfizer:

Primary Outcome Measures:

Diary events, including Satisfactory Sexual Experiences (SSEs) over 6 weeks. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Score in Abbreviated Sexual Function Questionnaire after 6 weeks of treatment. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Exit interview at end of study. Meaningful Benefit Question at end of study. [ Time Frame: End of study ] [ Designated as safety issue: No ]
Measure of Female Sexual Distress questionnaire after 6 weeks of treatment. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	84
Study Start Date:	July 2007
Study Completion Date:	October 2008
Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 mg: Experimental	Drug: CP-866,087 Tablets for oral administration
10 mg: Experimental	Drug: CP-866,087 Tablets for oral administration
3 mg: Experimental	Drug: CP-866,087 Tablets for oral administration
Placebo: Placebo Comparator	Drug: Placebo Tablets for oral administration

Eligibility

Criteria

Inclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00482664

Locations

Australia, South Australia
Pfizer Investigational Site
Dulwich, South Australia, Australia, 5065
Australia, Western Australia
Pfizer Investigational Site
NEDLANDS, Western Australia, Australia, 6009
Denmark
Pfizer Investigational Site
Kobenhavn OE, Denmark, 2100
Pfizer Investigational Site
Aarhus C, Denmark, 8000
Pfizer Investigational Site
Odense C, Denmark, 5000
Norway
Pfizer Investigational Site
Oslo, Norway, 0277
South Africa
Pfizer Investigational Site
Pretoria, South Africa, 0132
South Africa, Kwa-Zulu Natal
Pfizer Investigational Site
Westville, Kwa-Zulu Natal, South Africa, 3629
Sweden
Pfizer Investigational Site
Stockholm, Sweden, 141 86
Pfizer Investigational Site
Stockholm, Sweden, S-182 88
Pfizer Investigational Site
Skovde, Sweden, 541 30
Pfizer Investigational Site
Lund, Sweden, 221 85

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Responsible Party:	Pfizer Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A5051017
Study First Received:	June 1, 2007
Last Updated:	November 3, 2008
ClinicalTrials.gov Identifier:	NCT00482664
Health Authority:	Sweden: Regional Ethical Review Board

Study placed in the following topic categories:

Genital Diseases, Female
Sexual Dysfunctions, Psychological
Sexual Dysfunction, Physiological

Mental Disorders
Genital Diseases, Male
Menopause

Additional relevant MeSH terms:

Sexual and Gender Disorders

ClinicalTrials.gov processed this record on January 14, 2009