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 - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00800618

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 I

MedlinePlus related topics: Endometriosis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Pharmacokinetics/Dynamics Study
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.

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 ]

Estimated Enrollment:	40
Study Start Date:	November 2008
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
PF-02413873: Experimental 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: Placebo Comparator 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

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

Contacts

Contact: LeKeesha Miller-Jackson	001 203-401-0208	lekeesha.miller-jackson@pfizer.com
Contact: Pfizer CT.gov Call Center	1-800-718-1021

Locations

United States, Connecticut
Pfizer Investigational Site	Recruiting
New Haven, Connecticut, United States, 06511

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

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

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	B0461002
Study First Received:	December 1, 2008
Last Updated:	January 5, 2009
ClinicalTrials.gov Identifier:	NCT00800618
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Genital Diseases, Female
Endometriosis
Healthy

ClinicalTrials.gov processed this record on January 16, 2009