CClinicalTrials.gg
CompletedNCT00482664Updated Nov 1, 2010

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

A Phase 2 interventional study of CP-866,087 and CP-866,087 in Sexual Dysfunction, Physiological, sponsored by Pfizer. Completed at 12 sites in 5 countries. Open to female participants aged 20 Years to 45 Years. Per ClinicalTrials.gov, last updated 2010-11-01.

Sponsored by Pfizer · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
84
Allocation
Randomized
Ages
20 Years to 45 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Sexual Dysfunction, Physiological
03

In context

Sexual Dysfunction, Physiological

115 studies on the registry are indexed under Sexual Dysfunction, Physiological; 46 are open to participants now.

This study's planned enrollment of 84 is above the median of 60 across 80 interventional studies indexed under Sexual Dysfunction, Physiological.

Browse Sexual Dysfunction, Physiological studies →

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • healthy pre-menopausal women
  • primary female sexual arousal disorder causing distress
  • on stable use of oral contraceptives

Exclusion criteria

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
84 participants (estimated)

Study arms

  • Experimental
    1 mg

    Drug: CP-866,087

  • Experimental
    10 mg

    Drug: CP-866,087

  • Experimental
    3 mg

    Drug: CP-866,087

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • DrugCP-866,087

    Tablets for oral administration

  • DrugCP-866,087

    Tablets for oral administration

  • DrugCP-866,087

    Tablets for oral administration

  • DrugPlacebo

    Tablets for oral administration

06

What researchers measure

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

07

Study locations

12 sites
  • 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, Kwa-Zulu Natal 3629, South Africa
  • Pfizer Investigational Site
    Pretoria, 0132, South Africa
  • Pfizer Investigational Site
    Lund, 221 85, Sweden
  • Pfizer Investigational Site
    Skovde, 541 30, Sweden
  • Pfizer Investigational Site
    Stockholm, 141 86, Sweden
  • Pfizer Investigational Site
    Stockholm, S-182 88, Sweden
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 1, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00482664
Lead sponsor
Pfizer
First posted
Jun 5, 2007
Start date
Jul 2007
Primary completion
Sep 2008
Completion
Oct 2008
Last update
Nov 1, 2010

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2010. You cannot join it, but the record below documents what was studied.

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