Study Evaluating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PRA-027 in Japanese Postmenopausal Women
NCT00826436
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Descriptive Information | ||||
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Brief Title | Study Evaluating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PRA-027 in Japanese Postmenopausal Women | |||
Official Title | A Randomized, Placebo-Controlled, Double-Blind, Multiple-Dose Study of the Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of PRA-027 Administered Orally to Japanese Postmenopausal Women | |||
Brief Summary | The primary purpose of this study is to assess the safety and tolerability of ascending, multiple, oral doses of PRA-027 in Japanese postmenopausal women. The secondary purpose is to evaluate the PK and PD profile of multiple oral doses of PRA-027 in Japanese postmenopausal women. | |||
Detailed Description | Not Provided | |||
Study Type | Observational | |||
Study Design | Observational Model: Cohort Time Perspective: Prospective | |||
Target Follow-Up Duration | Not Provided | |||
Biospecimen | Retention: Samples With DNA Description: whole blood | |||
Sampling Method | Non-Probability Sample | |||
Study Population | community sample | |||
Condition | Uterine Leiomyomata (Fibroids) | |||
Intervention | Not Provided | |||
Study Groups/Cohorts |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status | Completed | |||
Estimated Enrollment | 16 | |||
Original Estimated Enrollment | Same as current | |||
Actual Study Completion Date | March 2009 | |||
Actual Primary Completion Date | March 2009 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | INCLUSION CRITERIA:
EXCLUSION CRITERIA:
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Sex/Gender |
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Ages | 35 Years to 65 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers | Yes | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | Japan | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT00826436 | |||
Other Study ID Numbers | 3208A1-1008 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth | |||
Study Sponsor | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Collaborators | Not Provided | |||
Investigators |
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PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Verification Date | March 2009 |