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

NCT03443089 | Completed Phase 1

• 1 other identifier: GDN 022/16
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Contraception

Keywords

medroxyprogesterone acetate; estradiol cypionate; bioavailability; monthly contraceptive

Outcome Measures

Primary Outcomes (2)

• Measurement of medroxyprogesterone acetate and estradiol cypionate plasma levels

  Blood sampling for the determination of plasma levels of medroxyprogesterone acetate and estradiol cypionate in participants of each treatment group.

  0-1008 hours after drug administration

• Measurement of estradiol cypionate plasma levels

  Blood sampling for the determination of plasma levels of estradiol cypionate in participants of each treatment group.

  -48 to 1008 hours after drug administration

Secondary Outcomes (5)

• Maximum Plasma Concentration (Cmax) of medroxyprogesterone acetate

  0 - 1008 hours after drug administration

• Maximum Plasma Concentration (Cmax) of estradiol cypionate

  0 - 1008 hours after drug administration

• Area Under the Curve (AUC) of medroxyprogesterone acetate

  0 - 1008 hours after drug administration

• Area Under the Curve (AUC) of estradiol cypionate

  0 - 1008 hours after drug administration

• Number of adverse events per participant

  Up to 1008 hours after drug administration

Study Arms (2)

Test formulation

EXPERIMENTAL

Single intramuscular dose administration (1 ampoule) of medroxyprogesterone acetate 25 mg/mL+ estradiol cypionate 5 mg/mL (Depomês®, Biolab Sanus Farmacêutica Ltda.)

Drug: Test formulation

Reference formulation

ACTIVE COMPARATOR

Single intramuscular dose administration (1 ampoule) of medroxyprogesterone acetate 25 mg/ampole + estradiol cypionate 5 mg/ampole (Cyclofemina®, Millet Roux Ltda.)

Drug: Reference formulation

Interventions

Test formulation DRUG

Administration of a single intramuscular dose of an injectable formulation containing medroxyprogesterone acetate 25 mg/mL + estradiol cypionate 5 mg/mL after an overnight fast.

Test formulation

Reference formulation DRUG

Administration of a single intramuscular dose of an injectable formulation containing medroxyprogesterone acetate 25 mg/ampole + estradiol cypionate 5 mg/ampole after an overnight fast.

Reference formulation

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Galeno Desenvolvimento de Pesquisas Clínicas: lead
• Biolab Sanus Farmaceutica: collaborator

Study Sites (1)

Galeno Desenvolvimento de Pesquisas Clinicas Ltda. - ME

Campinas, São Paulo, Brazil

Location

Study Officials

• Gilberto De Nucci, Doctor

  Galeno Desenvolvimento de Pesquisas Clinicas Ltda

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: February 16, 2018
• First Posted: February 22, 2018
• Study Start: March 31, 2017
• Primary Completion: April 2, 2017
• Study Completion: August 1, 2017
• Last Updated: February 23, 2018

Record last verified: 2018-02

Locations

BR (1)