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Sponsored by: |
Teva Pharmaceuticals USA |
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Information provided by: | Teva Pharmaceuticals USA |
ClinicalTrials.gov Identifier: | NCT00830414 |
This study compared the rates and extents of medroxyprogesterone absorption from two medroxyprogesterone acetate injection formulations following single 150 mg intramuscular (IM) injections to healthy postmenopausal women.
Condition | Intervention | Phase |
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Healthy |
Drug: medroxyprogesterone acetate |
Phase I |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Parallel Assignment, Bio-equivalence Study |
Official Title: | A Pivotal Study to Evaluate the Bioequivalence of 150 mg/1 mL Medroxyprogesterone Acetate Injection in Postmenopausal Women |
Enrollment: | 124 |
Study Start Date: | April 2002 |
Study Completion Date: | September 2002 |
Primary Completion Date: | September 2002 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: medroxyprogesterone acetate
IM Injection
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2: Active Comparator
DEPO-PROVERA®
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Drug: medroxyprogesterone acetate
IM injection
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Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
Ages Eligible for Study: | 45 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria
Screening will include general observations, physical examination, demographics, medical and medication history, an electrocardiogram, sitting blood pressure and pulse, respiratory rate and temperature. The physical examination will include, but may not be limited to, an evaluation of the cardiovascular, gastrointestinal, respiratory and central nervous systems. Screening will include a Gynecological examination (PAP smear, breast) which does not show clinically relevant findings, e.g. a cytological smear classified according to Papanicolau (PAP) higher than grade II.
The screening clinical laboratory procedures will include:
Is female and:
Exclusion Criteria
Study ID Numbers: | LA486 |
Study First Received: | January 26, 2009 |
Last Updated: | January 26, 2009 |
ClinicalTrials.gov Identifier: | NCT00830414 History of Changes |
Health Authority: | United States: Institutional Review Board |
Bioequivalence Healthy Subjects |
Medroxyprogesterone 17-Acetate Antineoplastic Agents, Hormonal Contraceptive Agents Contraceptives, Oral |
Contraceptive Agents, Female Medroxyprogesterone Healthy Contraceptive Agents, Male |
Medroxyprogesterone 17-Acetate Antineoplastic Agents, Hormonal Contraceptive Agents Antineoplastic Agents Contraceptives, Oral Physiological Effects of Drugs Contraceptive Agents, Female |
Reproductive Control Agents Contraceptive Agents, Male Pharmacologic Actions Therapeutic Uses Contraceptives, Oral, Synthetic Medroxyprogesterone |