Overview

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

Status:
Completed
Trial end date:
2017-08-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 1
Details
Lead Sponsor:
Galeno Desenvolvimento de Pesquisas Clínicas
Collaborator:
Biolab Sanus Farmaceutica
Treatments:
Estradiol
Estradiol 17 beta-cypionate
Estradiol 3-benzoate
Estradiol valerate
Medroxyprogesterone
Medroxyprogesterone Acetate
Polyestradiol phosphate