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

NCT00482664

Last updated date
Study Location
Pfizer Investigational Site
Dulwich, South Australia, 5065, Australia
Contact
1-800-718-1021

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Physiological Sexual Dysfunction
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
20-45 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- healthy pre-menopausal women

- primary female sexual arousal disorder causing distress

- on stable use of oral contraceptives

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

Physiological Sexual DysfunctionEffect Of Menstrual Cycle On Vaginal Blood Flow In Pre-Menopausal Healthy Women. NCT00443027
  1. Dulwich, South Australia
  2. Nedlands, Western Australia
Female
18 Years+
years
MULTIPLE SITES
Physiological Sexual DysfunctionThe Efficacy, Safety And Toleration Of CP-866,087 In Pre-Menopausal Women With Female Sexual Arousal Disorder. NCT00482664
  1. Dulwich, South Australia
  2. Nedlands, Western Australia
  3. Aarhus C,
  4. Kobenhavn OE,
  5. Odense C,
  6. Oslo,
  7. Westville, Kwa-Zulu Natal
  8. Pretoria,
  9. Lund,
  10. Skovde,
  11. Stockholm,
  12. Stockholm,
Female
20 Years+
years
MULTIPLE SITES
Physiological Sexual DysfunctionVaginal Heat Wash-out (HWO) in 4 Groups of Women (Pre- and Postmenopausal With and Without Female Sexual Arousal Disorder (FSAD)). NCT00443248
  1. Dulwich, South Australia
  2. Nedlands, Western Australia
Female
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE The Efficacy, Safety And Toleration Of CP-866,087 In Pre-Menopausal Women With Female Sexual Arousal Disorder.
Official Title  ICMJE 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).
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Sexual Dysfunction, Physiological
Intervention  ICMJE
  • Drug: CP-866,087
    Tablets for oral administration
  • Drug: Placebo
    Tablets for oral administration
Study Arms  ICMJE
  • Experimental: 1 mg
    Intervention: Drug: CP-866,087
  • Experimental: 10 mg
    Intervention: Drug: CP-866,087
  • Experimental: 3 mg
    Intervention: Drug: CP-866,087
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: June 1, 2007)
84
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2008
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
Ages  ICMJE 20 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Denmark,   Norway,   South Africa,   Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00482664
Other Study ID Numbers  ICMJE A5051017
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer Inc
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP