drugset
drugset / Trial / NCT03443089

Comparative Bioavailability of Two Injectable Suspension Formulations of Medroxyprogesterone Acetate+Estradiol Cypionate

NCT03443089 ↗

Phase 1 Completed 24 enrolled Galeno Desenvolvimento de Pesquisas Clínicas Biolab Sanus Farmaceutica · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2017-03-31
Primary completion
2017-04-02
Completion
2017-08-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Estradiol Cypionate Small molecule 5 mg/ml Intramuscular
Subject Estradiol Cypionate Small molecule 5 unknown Intramuscular
Subject medroxyprogesterone acetate Other / unclassified 25 mg/ml Intramuscular
Subject medroxyprogesterone acetate Other / unclassified 25 unknown Intramuscular

Indications

No indication recorded.