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NCT00482664 Clinical Trial

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

Sexual Dysfunction, Physiological Clinical Trial

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).

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00482664
Other study ID # A5051017
Secondary ID
Status Completed
Phase Phase 2
First received June 1, 2007
Last updated October 27, 2010
Start date July 2007
Est. completion date October 2008

Study information
Verified date October 2010
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority Sweden: Regional Ethical Review Board
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 84
Est. completion date October 2008
Est. primary completion date September 2008
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 45 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

  • Sexual Dysfunction, Physiological
  • Sexual Dysfunctions, Psychological

Intervention

Drug:
• CP-866,087
Tablets for oral administration
• CP-866,087
Tablets for oral administration
• CP-866,087
Tablets for oral administration
• Placebo
Tablets for oral administration

Locations
Country Name City State
Australia Pfizer Investigational Site Dulwich South Australia
Australia Pfizer Investigational Site Nedlands Western Australia
Denmark Pfizer Investigational Site Aarhus C
Denmark Pfizer Investigational Site Kobenhavn OE
Denmark Pfizer Investigational Site Odense C
Norway Pfizer Investigational Site Oslo
South Africa Pfizer Investigational Site Pretoria
South Africa Pfizer Investigational Site Westville Kwa-Zulu Natal
Sweden Pfizer Investigational Site Lund
Sweden Pfizer Investigational Site Skovde
Sweden Pfizer Investigational Site Stockholm
Sweden Pfizer Investigational Site Stockholm

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

Australia,  Denmark,  Norway,  South Africa,  Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary Diary events, including Satisfactory Sexual Experiences (SSEs) over 6 weeks. 6 weeks No
Primary Score in Abbreviated Sexual Function Questionnaire after 6 weeks of treatment. 6 weeks No
Secondary Exit interview at end of study. Meaningful Benefit Question at end of study. End of study No
Secondary Measure of Female Sexual Distress questionnaire after 6 weeks of treatment. 6 weeks No
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