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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00800618
Recruitment Status : Completed
First Posted : December 2, 2008
Last Update Posted : February 10, 2010
Sponsor:
Information provided by:
Pfizer

Study Description
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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

Condition or disease Intervention/treatment Phase
Endometriosis Drug: PF-02413873 100 mg QD Drug: PF-02413873 1500 mg QD Drug: PF-02413873 20 mg QD Drug: PF-02413873 500 mg QD Drug: PF-02413873 Placebo Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
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 Start Date : November 2008
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009
Arms and Interventions
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Arm Intervention/treatment
Experimental: PF-02413873
PF-2413873 active treatment
 Drug: PF-02413873 100 mg QD
100 mg of PF-02413873 oral suspension once daily for 14 days

Drug: PF-02413873 1500 mg QD
1500 mg of PF-02413873 oral suspension once daily for 14 days

Drug: PF-02413873 20 mg QD
20 mg of PF-02413873 oral suspension once daily for 14 days

Drug: PF-02413873 500 mg QD
500 mg of PF-02413873 oral suspension once daily for 14 days
Placebo Comparator: Placebo
Placebo
 Drug: PF-02413873 Placebo
PF-0241383 Placebo once daily for 14 days


Outcome Measures
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Primary Outcome Measures :
  1. Adverse events, vital signs measurements, 12-lead ECGs, physical examination findings, blood safety tests. [ Time Frame: 1 month ]
  2. PF-02413873 pharmacokinetics [ Time Frame: 1 month ]
  3. Endometrial thickness, Ovarian follicular estradiol secretion, Pre-ovulatory LH surge, Corpus Luteum progesterone secretion. [ Time Frame: 14 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00800618


Locations
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United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511
United States, Kansas
Pfizer Investigational Site
Overland Park, Kansas, United States, 66211
Pfizer Investigational Site
Overland Park, Kansas, United States, 66212
Belgium
Pfizer Investigational Site
Bruxelles, Belgium, 1070
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00800618    
Other Study ID Numbers: B0461002
First Posted: December 2, 2008    Key Record Dates
Last Update Posted: February 10, 2010
Last Verified: February 2010
Additional relevant MeSH terms:
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Endometriosis