Contraception Clinical Trial
Official title:
Comparative Bioavailability Study of Two Injectable Suspension Formulations, a Test (Medroxyprogesterone Acetate 25 mg/mL + Estradiol Cypionate 5 mg/mL) vs. a Reference (Medroxyprogesterone Acetate 25 mg/AMP + Estradiol Cypionate 5 mg/AMP)
This clinical trial evaluated the comparative bioavailability of two injectable suspension formulations of medroxyprogesterone acetate + estradiol cypionate, a test (Depomês®, 25 mg/mL medroxyprogesterone acetate + 5 mg/mL estradiol cypionate, Biolab Sanus Farmacêutica Ltda.) and a reference formulation (Cyclofemina®, 25 mg/0.5 mL medroxyprogesterone acetate + 5 mg/0.5 mL estradiol cypionate, Millet Roux Ltda.) in healthy female volunteers after a single intramuscular dose administration. In addition, this study also evaluated the safety and tolerability of these drugs.
This study was performed in a monocentric, open label, parallel design, with 2 treatments, 1
period, in which twelve subjects received the test product (Depomês®, 25 mg/mL
medroxyprogesterone acetate + 5 mg/mL estradiol cypionate, Biolab Sanus Farmacêutica Ltda.)
and twelve subjects received the reference product (Cyclofemina®, 25 mg/0.5 mL
medroxyprogesterone acetate + 5 mg/0.5 mL estradiol cypionate, Millet Roux Ltda.). The
formulations (test or reference) were administered in a single intramuscular dose (1 ampoule)
after an overnight fast (approximately 8 h). Blood samples (9 mL) were collected via a venous
catheter into heparinized tubes at times pre-dose (0 h) and 6, 12, 24, 48, 72, 96, 120, 168,
240, 288, 336, 432, 504, 672, 840, 1008, 1176, 1344, 1512, 1680, 1848, and 2016 h after drug
administration to measure medroxyprogesterone; and pre-dose (-48, -24 and 0 h) e 2, 4, 6, 8,
10, 12, 24, 48, 72, 96, 120, 168, 240, 288, 336, 432, 504, 672, 840, and 1008 h after drug
administration to measure estradiol cypionate.
The safety assessment was based on recording adverse events throughout the study duration.
The subjects systolic and diastolic pressures, heart rate and temperature were determined
prior and at approximately 4, 8 and 12 h after drug administration. The clinical evaluation
and the laboratory tests were also performed at the end of the study.
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