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

• Status: Completed
• Trial end date: 2017-08-01
• Target enrollment: 0
• Participant gender: Female

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
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

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

Criteria

Inclusion Criteria:

• Body-mass index (BMI) ≥19.0 kg/m² and ≤ 27.5 kg/m²

• With regular cycles, without use of hormonal contraceptives (pills at least 3 months and injectables at least 1 year) and not using hormone replacement therapy

• Not pregnant or breastfeeding

• Good state of health

• Non-smoker or ex-smoker for at least 6 month

• Written informed consent, after having been informed about benefits and potential risks of the clinical trial, as well as details of the insurance taken out to cover the subjects participating in the clinical trial

Exclusion Criteria:

• Existing cardiac, hepatic and/or haematological diseases or pathological findings, which might interfere with the safety or tolerability and/or pharmacokinetics and/or pharmacodynamics of the active ingredient

• History of relevant central nervous system (CNS) and/or psychiatric disorders and/or currently treated CNS and/or psychiatric disorders

• Known allergic reactions to the active ingredients used or to constituents of the pharmaceutical preparations

• Subjects with severe allergies or multiple drug allergies, unless it is judged as not relevant for the clinical trial by the investigator

• Positive anti-HIV-test (if positive to be verified by western blot), HBs-AGtest (if positive to be verified by test for HBc-IgM) or anti-HCV-test

• Admitted for any reason up to 8 weeks before the start of the first treatment period of this study

• History of or current drug or alcohol dependence

• Subjects who are on a diet which could affect the pharmacokinetics of the active ingredient

• Regular intake of caffeine containing food or beverages of ≥ 500 mg caffeine per day

• Blood donation or other blood loss of more than 400 ml within the last 3 months prior to individual enrolment of the subject

• Participation in a clinical trial during the last 6 months prior to individual enrolment of the subject

• Positive pregnancy test, delivery or abortion in the 12 weeks prior to the planned hospitalization date.

• Subjects who are unable to understand the written and verbal instructions, in particular regarding the risks and inconveniences they will be exposed to during their participation in the clinical trial