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).

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00482664

Enrollment

Registered

2007-06-05

Start date

2007-07-31

Completion date

2008-10-31

Last updated

2010-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sexual Dysfunction, Physiological

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.

Interventions

DRUGCP-866,087

Tablets for oral administration

DRUGPlacebo

Tablets for oral administration

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 45 Years

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

Australia, Denmark, Norway, South Africa, Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026