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

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ClinicalTrials.gov Identifier: NCT00482664
Recruitment Status : Completed
First Posted : June 5, 2007
Last Update Posted : November 1, 2010
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Sexual Dysfunction, Physiological Drug: CP-866,087 Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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).
Study Start Date : July 2007
Actual Primary Completion Date : September 2008
Actual Study Completion Date : October 2008

Arm Intervention/treatment
Experimental: 1 mg Drug: CP-866,087
Tablets for oral administration

Experimental: 10 mg Drug: CP-866,087
Tablets for oral administration

Experimental: 3 mg Drug: CP-866,087
Tablets for oral administration

Placebo Comparator: Placebo Drug: Placebo
Tablets for oral administration




Primary Outcome Measures :
  1. Diary events, including Satisfactory Sexual Experiences (SSEs) over 6 weeks. [ Time Frame: 6 weeks ]
  2. Score in Abbreviated Sexual Function Questionnaire after 6 weeks of treatment. [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. Exit interview at end of study. Meaningful Benefit Question at end of study. [ Time Frame: End of study ]
  2. Measure of Female Sexual Distress questionnaire after 6 weeks of treatment. [ Time Frame: 6 weeks ]


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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Aarhus C, Denmark, 8000
Pfizer Investigational Site
Kobenhavn OE, Denmark, 2100
Pfizer Investigational Site
Odense C, Denmark, 5000
Norway
Pfizer Investigational Site
Oslo, Norway, 0277
South Africa
Pfizer Investigational Site
Westville, Kwa-Zulu Natal, South Africa, 3629
Pfizer Investigational Site
Pretoria, South Africa, 0132
Sweden
Pfizer Investigational Site
Lund, Sweden, 221 85
Pfizer Investigational Site
Skovde, Sweden, 541 30
Pfizer Investigational Site
Stockholm, Sweden, 141 86
Pfizer Investigational Site
Stockholm, Sweden, S-182 88
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier: NCT00482664     History of Changes
Other Study ID Numbers: A5051017
First Posted: June 5, 2007    Key Record Dates
Last Update Posted: November 1, 2010
Last Verified: October 2010

Additional relevant MeSH terms:
Sexual Dysfunctions, Psychological
Sexual Dysfunction, Physiological
Mental Disorders
Genital Diseases, Male
Genital Diseases, Female