Medroxyprogesterone Acetate Injection 150 mg/1 mL in Postmenopausal Women (NCT00830414) | Clinical Trial Compass
CompletedPhase 1
Medroxyprogesterone Acetate Injection 150 mg/1 mL in Postmenopausal Women
Germany124 participantsStarted 2002-04
Plain-language summary
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.
Who can participate
Age range45 Years
SexFEMALE
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Inclusion Criteria
* Screening Demographics: All volunteers selected for this study will be healthy postmenopausal women 45 years of age or older at the time of dosing. The weight range will not exceed ±20% for height and body frame as per Desirable Weights for Women - 1983 Metropolitan Height and Weight Table.
* Screening Procedures: Each volunteer will complete the screening process within 28 days prior to period I dosing. Consent documents for both the screening evaluation and HIV antibody determination will be reviewed, discussed and signed by each potential participant before full implementation of screening procedures.
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:
* HEMATOLOGY: hematocrit, hemoglobin, WBC count with differential, RBC count, platelet count
* CLINICAL CHEMISTRY: serum creatinine, BUN, glucose, AST(GOT), ALT(GPT), albumin, total bilirubin, total protein, and alkaline phospha…