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Sponsored by: |
Wyeth |
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Information provided by: | Wyeth |
ClinicalTrials.gov Identifier: | NCT00826436 |
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.
Condition |
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Uterine Leiomyomata (Fibroids) |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
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 |
whole blood
Estimated Enrollment: | 16 |
Study Start Date: | November 2008 |
Study Completion Date: | March 2009 |
Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
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8 subjects for Cohort 1 |
8 subjects for Cohort 2 |
Ages Eligible for Study: | 35 Years to 65 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
community sample
INCLUSION CRITERIA:
Aged 35 to 65 years inclusive on study day 1 of the treatment period. Menopause may be spontaneous or due to surgery.
Postmenopausal women are defined as follows:
Body mass index (BMI) in the range of 17.6 to 26.4 kg/m2 and bodyweight ≥ 45 kg.
BMI is calculated by taking the subject's weight, in kilograms, divided by the square of the subject's average height, in meters, at screening:BMI = weight (kg)/[Height (m)]2
EXCLUSION CRITERIA:
Any significant cardiovascular, hepatic, renal, respiratory,gynecologic, gastrointestinal, endocrine, immunologic,dermatologic, hematologic, neurologic, or psychiatric disease.
Responsible Party: | Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) ) |
Study ID Numbers: | 3208A1-1008 |
Study First Received: | January 20, 2009 |
Last Updated: | March 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00826436 History of Changes |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Neoplasms, Connective and Soft Tissue Myofibroma Connective Tissue Diseases Leiomyoma |
Neoplasms, Connective and Soft Tissue Neoplasms, Muscle Tissue Neoplasms Myofibroma |
Neoplasms by Histologic Type Connective Tissue Diseases Neoplasms, Connective Tissue Leiomyoma |