NCT00479570

Brief Summary

The 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2007

Shorter than P25 for phase_2

Geographic Reach
3 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 24, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 28, 2007

Completed
4 days until next milestone

Study Start

First participant enrolled

June 1, 2007

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
Last Updated

January 31, 2019

Status Verified

January 1, 2019

Enrollment Period

8 months

First QC Date

May 24, 2007

Last Update Submit

January 29, 2019

Conditions

Female Sexual Dysfunction

Outcome Measures

Primary Outcomes (1)

  • Assess effect of single doses of PF-00446687 on acute sexual arousal and sexual interest, using questionnaires, in post menopausal women suffering from Female Sexual Dysfunction. A diary will be completed for 7 days following the 3 dosing days.

    From day of dosing until 7 days post-dose

Secondary Outcomes (4)

  • Assess effect of single doses on medium term (1 week) sexual arousal and interest.

    Until 7 days post-dose

  • Assess variability of response and repeatability of design between 2 similar doses.

    Comparison of response to be assessed until 7 days post dose

  • If possible assess the effect of PF-00446687 on vaginal blood flow on day 1 of each study period.

    Day of dosing

  • Assess PK , safety and toleration on day 1 of each study period.

    Day of dosing

Study Arms (2)

Study period 1, 2 or 3

EXPERIMENTAL
Drug: PF-00446687

Placebo Study period 1, 2 or 3

PLACEBO COMPARATOR
Drug: Placebo

Interventions

PF-00446687DRUG

Single 200mg dose

Study period 1, 2 or 3
PlaceboDRUG
Placebo Study period 1, 2 or 3

Eligibility Criteria

Age45 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Pfizer Investigational Site

Kobenhavn OE, 2100, Denmark

Location

Pfizer Investigational Site

Oslo, Norway

Location

Pfizer Investigational Site

Danderyd, S-182 88, Sweden

Location

Related Links

MeSH Terms

Interventions

1-((1-tert-butyl-4-(2,4-difluorophenyl)pyrrolidin-3-yl)carbonyl)-3,5-dimethyl-4-phenylpiperidin-4-ol

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 24, 2007

First Posted

May 28, 2007

Study Start

June 1, 2007

Primary Completion

February 1, 2008

Study Completion

February 1, 2008

Last Updated

January 31, 2019

Record last verified: 2019-01

Locations

DK(1)SE(1)NO(1)