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
Phase 1
Completed
- Conditions
- Endometriosis
- Interventions
- Drug: PF-02413873 100 mg QDDrug: PF-02413873 PlaceboDrug: PF-02413873 1500 mg QDDrug: PF-02413873 20 mg QDDrug: PF-02413873 500 mg QD
- Registration Number
- NCT00800618
- Lead Sponsor
- Pfizer
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 42
Inclusion Criteria
- Healthy women of childbearing potential with a regular menstrual cycle
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Exclusion Criteria
- Evidence or history of any major disease
- Pregnant or nursing women
- Requirement for chronic medication
Read More
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PF-02413873 PF-02413873 100 mg QD PF-2413873 active treatment PF-02413873 PF-02413873 20 mg QD PF-2413873 active treatment PF-02413873 PF-02413873 1500 mg QD PF-2413873 active treatment PF-02413873 PF-02413873 500 mg QD PF-2413873 active treatment Placebo PF-02413873 Placebo Placebo
- Primary Outcome Measures
Name Time Method Adverse events, vital signs measurements, 12-lead ECGs, physical examination findings, blood safety tests. 1 month PF-02413873 pharmacokinetics 1 month Endometrial thickness, Ovarian follicular estradiol secretion, Pre-ovulatory LH surge, Corpus Luteum progesterone secretion. 14 days
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇧🇪Bruxelles, Belgium