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

October 27, 2010 updated by: Pfizer

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).

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

84

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • South Australia
      • Dulwich, South Australia, Australia, 5065
        • Pfizer Investigational Site
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Pfizer Investigational Site
  • Denmark
      • Aarhus C, Denmark, 8000
        • Pfizer Investigational Site
      • Kobenhavn OE, Denmark, 2100
        • Pfizer Investigational Site
      • Odense C, Denmark, 5000
        • Pfizer Investigational Site
  • Norway
      • Oslo, Norway, 0277
        • Pfizer Investigational Site
  • South Africa
      • Pretoria, South Africa, 0132
        • Pfizer Investigational Site
    • Kwa-Zulu Natal
      • Westville, Kwa-Zulu Natal, South Africa, 3629
        • Pfizer Investigational Site
  • Sweden
      • 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
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Tablets for oral administration
Experimental: 10 mg
Drug: CP-866,087
Tablets for oral administration
Experimental: 1 mg
Drug: CP-866,087
Tablets for oral administration
Experimental: 3 mg
Drug: CP-866,087
Tablets for oral administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Diary events, including Satisfactory Sexual Experiences (SSEs) over 6 weeks.
Time Frame: 6 weeks
6 weeks
Score in Abbreviated Sexual Function Questionnaire after 6 weeks of treatment.
Time Frame: 6 weeks
6 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

October 1, 2008

Study Registration Dates

First Submitted

June 1, 2007

First Submitted That Met QC Criteria

June 1, 2007

First Posted (Estimate)

June 5, 2007

Study Record Updates

Last Update Posted (Estimate)

November 1, 2010

Last Update Submitted That Met QC Criteria

October 27, 2010

Last Verified

October 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A5051017

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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