Pharmacokinetic and Pharmacodynamic Study of Cyclofem
Completed
Sun Pharmaceutical Industries Limited
Phase 1/Phase 2
2010-06-01
Cyclofem® is a monthly injectable contraceptive containing 25 mg of medroxyprogesterone
acetate (MPA) and 5 mg of estradiol cypionate (E2C), a long-acting ester of estradiol. The
current study will assess the steady-state pharmacokinetics and pharmacodynamics of
medroxyprogesterone acetate (MPA) and estradiol (E2) after administration of Cyclofem® and
will provide critical information to determine similar bioavailability of Cyclofem to Lunelle
in women residing in the United States of America.
Comparative Bioavailability of Two Injectable Suspension Formulations of Medroxyprogesterone Acetate+Estradiol Cypionate
Completed
Biolab Sanus Farmaceutica
Phase 1
2017-03-31
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.
Comparative Bioavailability of Two Injectable Suspension Formulations of Medroxyprogesterone Acetate+Estradiol Cypionate
Completed
Galeno Desenvolvimento de Pesquisas Clínicas
Phase 1
2017-03-31
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.
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