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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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00800618
First received: December 1, 2008
Last updated: February 9, 2010
Last verified: February 2010
  Purpose

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 Intervention 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 Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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.

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Adverse events, vital signs measurements, 12-lead ECGs, physical examination findings, blood safety tests. [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  • PF-02413873 pharmacokinetics [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Endometrial thickness, Ovarian follicular estradiol secretion, Pre-ovulatory LH surge, Corpus Luteum progesterone secretion. [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Enrollment: 42
Study Start Date: November 2008
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00800618

Locations
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
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00800618     History of Changes
Other Study ID Numbers: B0461002
Study First Received: December 1, 2008
Last Updated: February 9, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Endometriosis
Genital Diseases, Female

ClinicalTrials.gov processed this record on November 24, 2014