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OpenTrials
Completed

NCT Number: NCT00482664

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

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.

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Key information

Conditions

Sexual Dysfunction, Physiological Genital Diseases Urogenital Diseases

Age range

20 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Pfizer Investigational Site, Dulwich, South Australia, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CP-866,087

Drug

Tablets for oral administration

Placebo

Drug

Tablets for oral administration

Primary outcomes

  1. Diary events, including Satisfactory Sexual Experiences (SSEs) over 6 weeks.

    Time frame: 6 weeks

  2. Score in Abbreviated Sexual Function Questionnaire after 6 weeks of treatment.

    Time frame: 6 weeks

Secondary outcomes

  1. Exit interview at end of study. Meaningful Benefit Question at end of study.

    Time frame: End of study

  2. Measure of Female Sexual Distress questionnaire after 6 weeks of treatment.

    Time frame: 6 weeks

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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).

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jun 5, 2007
Registry last updated
Nov 1, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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