Back to resultsA Study To Investigate How The Body Handles Multiple Doses Of PF-0243873 And To Investigate The Effect Of PF-02413873 On Sex Hormone Levels In Healthy Young Women
Primary Purpose
Endometriosis
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
PF-02413873 100 mg QD
PF-02413873 1500 mg QD
PF-02413873 20 mg QD
PF-02413873 500 mg QD
PF-02413873 Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Endometriosis
Eligibility Criteria
Inclusion Criteria:
- Healthy women of childbearing potential with a regular menstrual cycle
Exclusion Criteria:
- Evidence or history of any major disease
- Pregnant or nursing women
- Requirement for chronic medication
Sites / Locations
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
PF-02413873
Placebo
Arm Description
PF-2413873 active treatment
Placebo
Outcomes
Primary Outcome Measures
Adverse events, vital signs measurements, 12-lead ECGs, physical examination findings, blood safety tests.
PF-02413873 pharmacokinetics
Endometrial thickness, Ovarian follicular estradiol secretion, Pre-ovulatory LH surge, Corpus Luteum progesterone secretion.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00800618
Brief Title
A Study To Investigate How The Body Handles Multiple Doses Of PF-0243873 And To Investigate The Effect Of PF-02413873 On Sex Hormone Levels In Healthy Young Women
Official Title
A Double Blind (3rd Party Open), Randomised, Placebo Controlled, Dose Escalating, Parallel Group Study To Investigate The Safety, Toleration, Pharmacology And Pharmacokinetics, Of Multiple Doses Of PF-02413873 In Healthy Female Subjects.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2010
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study will investigate how well multiple doses of PF-02413873 are tolerated by healthy young women, how the body handles multiple doses of PF-02413873 and which effect PF-02413873 has on sex hormones in healthy young women
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PF-02413873
Arm Type
Experimental
Arm Description
PF-2413873 active treatment
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
PF-02413873 100 mg QD
Intervention Description
100 mg of PF-02413873 oral suspension once daily for 14 days
Intervention Type
Drug
Intervention Name(s)
PF-02413873 1500 mg QD
Intervention Description
1500 mg of PF-02413873 oral suspension once daily for 14 days
Intervention Type
Drug
Intervention Name(s)
PF-02413873 20 mg QD
Intervention Description
20 mg of PF-02413873 oral suspension once daily for 14 days
Intervention Type
Drug
Intervention Name(s)
PF-02413873 500 mg QD
Intervention Description
500 mg of PF-02413873 oral suspension once daily for 14 days
Intervention Type
Drug
Intervention Name(s)
PF-02413873 Placebo
Intervention Description
PF-0241383 Placebo once daily for 14 days
Primary Outcome Measure Information:
Title
Adverse events, vital signs measurements, 12-lead ECGs, physical examination findings, blood safety tests.
Time Frame
1 month
Title
PF-02413873 pharmacokinetics
Time Frame
1 month
Title
Endometrial thickness, Ovarian follicular estradiol secretion, Pre-ovulatory LH surge, Corpus Luteum progesterone secretion.
Time Frame
14 days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy women of childbearing potential with a regular menstrual cycle
Exclusion Criteria:
Evidence or history of any major disease
Pregnant or nursing women
Requirement for chronic medication
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
Facility Name
Pfizer Investigational Site
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
Facility Name
Pfizer Investigational Site
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66212
Country
United States
Facility Name
Pfizer Investigational Site
City
Bruxelles
ZIP/Postal Code
1070
Country
Belgium
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B0461002&StudyName=A%20Study%20To%20Investigate%20How%20The%20Body%20Handles%20Multiple%20Doses%20Of%20PF-0243873%20And%20To%20Investigate%20The%20Effect%20Of%20PF-02413873%20On%20Sex%20Hormone
Description
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A Study To Investigate How The Body Handles Multiple Doses Of PF-0243873 And To Investigate The Effect Of PF-02413873 On Sex Hormone Levels In Healthy Young Women
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