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:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00800618
First received: December 1, 2008
Last updated: February 9, 2010
Last verified: February 2010
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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 Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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:
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 ]
| 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 |
| 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
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:
No publications provided
| 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 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Endometriosis Genital Diseases, Female |
ClinicalTrials.gov processed this record on May 21, 2013