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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00482664
• Date of registration: 01/06/2007
• Prospective Registration: Yes
• Primary sponsor: Pfizer
• Public title: The Efficacy, Safety And Toleration Of CP-866,087 In Pre-Menopausal Women With Female Sexual Arousal Disorder.
• Scientific 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).
• Date of first enrolment: July 2007
• Target sample size: 84
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00482664
• 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
• Phase: Phase 2

Countries of recruitment

Australia, Denmark, Norway, South Africa, Sweden

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion 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



Age minimum: 20 Years
Age maximum: 45 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Sexual Dysfunction, Physiological

Intervention(s)

Drug: Placebo

Drug: CP-866,087

Primary Outcome(s)

Score in Abbreviated Sexual Function Questionnaire after 6 weeks of treatment. [Time Frame: 6 weeks]

Diary events, including Satisfactory Sexual Experiences (SSEs) over 6 weeks. [Time Frame: 6 weeks]

Secondary Outcome(s)

Exit interview at end of study. Meaningful Benefit Question at end of study. [Time Frame: End of study]

Measure of Female Sexual Distress questionnaire after 6 weeks of treatment. [Time Frame: 6 weeks]

Secondary ID(s)

A5051017

Source(s) of Monetary Support

Please refer to primary and secondary sponsors