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

History of Changes

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 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.

Resource links provided by NLM:

MedlinePlus related topics: Endometriosis

U.S. FDA Resources

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 ]
PF-02413873 pharmacokinetics [ Time Frame: 1 month ]
Endometrial thickness, Ovarian follicular estradiol secretion, Pre-ovulatory LH surge, Corpus Luteum progesterone secretion. [ Time Frame: 14 days ]


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 (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

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:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site


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

Additional relevant MeSH terms:


Endometriosis Genital Diseases, Female

ClinicalTrials.gov processed this record on August 18, 2017

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