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

Primary Purpose

Sexual Dysfunction, Physiological

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
CP-866,087
CP-866,087
CP-866,087
Placebo
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sexual Dysfunction, Physiological

Eligibility Criteria

20 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

1 mg

10 mg

3 mg

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Exit interview at end of study. Meaningful Benefit Question at end of study.
Measure of Female Sexual Distress questionnaire after 6 weeks of treatment.

Full Information

First Posted
June 1, 2007
Last Updated
October 27, 2010
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00482664
Brief Title
The Efficacy, Safety And Toleration Of CP-866,087 In Pre-Menopausal Women With Female Sexual Arousal Disorder.
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 Type
Interventional

2. Study Status

Record Verification Date
October 2010
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
October 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sexual Dysfunction, Physiological

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1 mg
Arm Type
Experimental
Arm Title
10 mg
Arm Type
Experimental
Arm Title
3 mg
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
CP-866,087
Intervention Description
Tablets for oral administration
Intervention Type
Drug
Intervention Name(s)
CP-866,087
Intervention Description
Tablets for oral administration
Intervention Type
Drug
Intervention Name(s)
CP-866,087
Intervention Description
Tablets for oral administration
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Tablets for oral administration
Primary Outcome Measure Information:
Title
Diary events, including Satisfactory Sexual Experiences (SSEs) over 6 weeks.
Time Frame
6 weeks
Title
Score in Abbreviated Sexual Function Questionnaire after 6 weeks of treatment.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Exit interview at end of study. Meaningful Benefit Question at end of study.
Time Frame
End of study
Title
Measure of Female Sexual Distress questionnaire after 6 weeks of treatment.
Time Frame
6 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Dulwich
State/Province
South Australia
ZIP/Postal Code
5065
Country
Australia
Facility Name
Pfizer Investigational Site
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Pfizer Investigational Site
City
Aarhus C
ZIP/Postal Code
8000
Country
Denmark
Facility Name
Pfizer Investigational Site
City
Kobenhavn OE
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Pfizer Investigational Site
City
Odense C
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Pfizer Investigational Site
City
Oslo
ZIP/Postal Code
0277
Country
Norway
Facility Name
Pfizer Investigational Site
City
Westville
State/Province
Kwa-Zulu Natal
ZIP/Postal Code
3629
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Pretoria
ZIP/Postal Code
0132
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Lund
ZIP/Postal Code
221 85
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Skovde
ZIP/Postal Code
541 30
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Stockholm
ZIP/Postal Code
141 86
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Stockholm
ZIP/Postal Code
S-182 88
Country
Sweden

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A5051017&StudyName=The%20Efficacy%2C%20Safety%20And%20Toleration%20Of%20CP-866%2C087%20In%20Pre-Menopausal%20Women%20With%20Female%20Sexual%20Arousal%20Disorder.
Description
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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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