The Efficacy, Safety And Toleration Of CP-866,087 In Pre-Menopausal Women With Female Sexual Arousal Disorder.
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).
1 other identifier
interventional
84
5 countries
12
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jul 2007
Shorter than P25 for phase_2
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 1, 2007
CompletedFirst Posted
Study publicly available on registry
June 5, 2007
CompletedStudy Start
First participant enrolled
July 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2008
CompletedNovember 1, 2010
October 1, 2010
1.2 years
June 1, 2007
October 27, 2010
Conditions
Outcome Measures
Primary Outcomes (2)
Diary events, including Satisfactory Sexual Experiences (SSEs) over 6 weeks.
6 weeks
Score in Abbreviated Sexual Function Questionnaire after 6 weeks of treatment.
6 weeks
Secondary Outcomes (2)
Exit interview at end of study. Meaningful Benefit Question at end of study.
End of study
Measure of Female Sexual Distress questionnaire after 6 weeks of treatment.
6 weeks
Study Arms (4)
1 mg
EXPERIMENTAL10 mg
EXPERIMENTAL3 mg
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- healthy pre-menopausal women
- primary female sexual arousal disorder causing distress
- on stable use of oral contraceptives
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (12)
Pfizer Investigational Site
Dulwich, South Australia, 5065, Australia
Pfizer Investigational Site
Nedlands, Western Australia, 6009, Australia
Pfizer Investigational Site
Aarhus C, 8000, Denmark
Pfizer Investigational Site
Kobenhavn OE, 2100, Denmark
Pfizer Investigational Site
Odense C, 5000, Denmark
Pfizer Investigational Site
Oslo, 0277, Norway
Pfizer Investigational Site
Westville, KwaZulu-Natal, 3629, South Africa
Pfizer Investigational Site
Pretoria, 0132, South Africa
Pfizer Investigational Site
Lund, 221 85, Sweden
Pfizer Investigational Site
Skövde, 541 30, Sweden
Pfizer Investigational Site
Stockholm, 141 86, Sweden
Pfizer Investigational Site
Stockholm, S-182 88, Sweden
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 1, 2007
First Posted
June 5, 2007
Study Start
July 1, 2007
Primary Completion
September 1, 2008
Study Completion
October 1, 2008
Last Updated
November 1, 2010
Record last verified: 2010-10