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

Endometriosis Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00800618
• Other study ID #: B0461002
• Status: Completed
• Phase: Phase 1
• First received: December 1, 2008
• Last updated: February 9, 2010
• Start date: November 2008
• Est. completion date: June 2009

Study information

• Verified date: February 2010
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Endometriosis

Intervention

Drug:
• PF-02413873 100 mg QD
100 mg of PF-02413873 oral suspension once daily for 14 days
• PF-02413873 1500 mg QD
1500 mg of PF-02413873 oral suspension once daily for 14 days
• PF-02413873 20 mg QD
20 mg of PF-02413873 oral suspension once daily for 14 days
• PF-02413873 500 mg QD
500 mg of PF-02413873 oral suspension once daily for 14 days
• PF-02413873 Placebo
PF-0241383 Placebo once daily for 14 days

Locations

Country	Name	City	State
Belgium	Pfizer Investigational Site	Bruxelles
United States	Pfizer Investigational Site	New Haven	Connecticut
United States	Pfizer Investigational Site	Overland Park	Kansas
United States	Pfizer Investigational Site	Overland Park	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events, vital signs measurements, 12-lead ECGs, physical examination findings, blood safety tests.		1 month	Yes
Primary	PF-02413873 pharmacokinetics		1 month	No
Primary	Endometrial thickness, Ovarian follicular estradiol secretion, Pre-ovulatory LH surge, Corpus Luteum progesterone secretion.		14 days	No

External Links

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