Status:
COMPLETED
Comparative Bioavailability of Two Injectable Suspension Formulations of Medroxyprogesterone Acetate+Estradiol Cypionate
Lead Sponsor:
Galeno Desenvolvimento de Pesquisas Clínicas
Collaborating Sponsors:
Biolab Sanus Farmaceutica
Conditions:
Contraception
Eligibility:
FEMALE
18-45 years
Phase:
PHASE1
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 medroxyprogeste...
Detailed Description
This study was performed in a monocentric, open label, parallel design, with 2 treatments, 1 period, in which twelve subjects received the test product (Depomês®, 25 mg/mL medroxyprogesterone acetate ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 31 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2017
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03443089
Start Date
March 31 2017
End Date
August 1 2017
Last Update
February 23 2018
Active Locations (1)
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1
Galeno Desenvolvimento de Pesquisas Clinicas Ltda. - ME
Campinas, São Paulo, Brazil