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Study To Investigate Effect Of A New Drug (PF-00446687) In Post-Menopausal Women Who Suffer From Sexual Dysfunction.

Last updated on November 15, 2019

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Study Location
Pfizer Investigational Site
Kobenhavn OE, , 2100 Denmark
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Female Sexual Dysfunction
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
45-65 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Women who have evidence of Female Sexual Arousal Disorder.

- Women who experience personal distress due to Female Sexual Dysfunction.

- Post menopausal women aged between 45 and 65 years.

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

- Women whose sexual dysfunction is limited to certain types of stimulation, situation
or specific partners.

- Women who experience pain with sexual intercourse or who have a sexual aversion
disorder.

- Women suffering from female sexual dysfunction where the cause is treatable, for
example inadequately controlled diabetes or thyroid dysfunction.

NCT00479570
Pfizer
Completed
Study To Investigate Effect Of A New Drug (PF-00446687) In Post-Menopausal Women Who Suffer From Sexual Dysfunction.

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Descriptive Information
Brief Title  ICMJE Study To Investigate Effect Of A New Drug (PF-00446687) In Post-Menopausal Women Who Suffer From Sexual Dysfunction.
Official Title  ICMJE Phase 2A Multi-Centre, Double Blind, Placebo Controlled 3-Way Cross-Over Study To Investigate The Effect Of Single Doses Of PF-00446687 On Sexual Arousal And Sexual Desire In Women Suffering From Female Sexual Dysfunction (FSD).
Brief SummaryThe purpose of this study is to investigate the effect of up to 200 mg of PF-00446687 on acute sexual arousal and sexual interest in post menopausal females, as well as examining the safety and toleration of the drug.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Female Sexual Dysfunction
Intervention  ICMJE
  • Drug: PF-00446687
    Single 200mg dose
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: Study period 1, 2 or 3
    Intervention: Drug: PF-00446687
  • Placebo Comparator: Placebo Study period 1, 2 or 3
    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
Actual Enrollment  ICMJE
 (submitted: April 4, 2008)
23
Original Enrollment  ICMJE
 (submitted: May 25, 2007)
24
Actual Study Completion Date  ICMJE February 2008
Actual Primary Completion DateFebruary 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Women who have evidence of Female Sexual Arousal Disorder.
  • Women who experience personal distress due to Female Sexual Dysfunction.
  • Post menopausal women aged between 45 and 65 years.

Exclusion Criteria:

  • Women whose sexual dysfunction is limited to certain types of stimulation, situation or specific partners.
  • Women who experience pain with sexual intercourse or who have a sexual aversion disorder.
  • Women suffering from female sexual dysfunction where the cause is treatable, for example inadequately controlled diabetes or thyroid dysfunction.
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
Ages  ICMJE 45 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark,   Norway,   Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00479570
Other Study ID Numbers  ICMJE A8361015
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyDirector, Clinical Trial Disclosure Group, Pfizer Inc
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateJanuary 2019

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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