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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00482664
First received: June 1, 2007
Last updated: October 27, 2010
Last verified: October 2010
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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).

Resource links provided by NLM:


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
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

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders 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
  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: 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
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier: NCT00482664     History of Changes
Other Study ID Numbers: A5051017
Study First Received: June 1, 2007
Last Updated: October 27, 2010
Health Authority: Sweden: Regional Ethical Review Board

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

ClinicalTrials.gov processed this record on September 18, 2014