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
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ClinicalTrials.gov Identifier: NCT00800618 |
Recruitment Status :
Completed
First Posted : December 2, 2008
Last Update Posted : February 10, 2010
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Condition or disease | Intervention/treatment | Phase |
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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 (Clinical Trial) |
Actual Enrollment : | 42 participants |
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. |
Study Start Date : | November 2008 |
Actual Primary Completion Date : | June 2009 |
Actual Study Completion Date : | June 2009 |
Arm | Intervention/treatment |
---|---|
Experimental: PF-02413873
PF-2413873 active treatment
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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
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Drug: PF-02413873 Placebo
PF-0241383 Placebo once daily for 14 days |
- 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 ]

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Ages Eligible for Study: | 18 Years to 35 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00800618
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 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
ClinicalTrials.gov Identifier: | NCT00800618 |
Other Study ID Numbers: |
B0461002 |
First Posted: | December 2, 2008 Key Record Dates |
Last Update Posted: | February 10, 2010 |
Last Verified: | February 2010 |
Endometriosis |