Contraception Clinical Trial
Official title:
Comparative Bioavailability Study of Two Injectable Suspension Formulations, a Test (Medroxyprogesterone Acetate 25 mg/mL + Estradiol Cypionate 5 mg/mL) vs. a Reference (Medroxyprogesterone Acetate 25 mg/AMP + Estradiol Cypionate 5 mg/AMP)
Verified date | February 2018 |
Source | Galeno Desenvolvimento de Pesquisas Clínicas |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 24 |
Est. completion date | August 1, 2017 |
Est. primary completion date | April 2, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Brazil | Galeno Desenvolvimento de Pesquisas Clinicas Ltda. - ME | Campinas | SP |
Lead Sponsor | Collaborator |
---|---|
Galeno Desenvolvimento de Pesquisas Clínicas | Biolab Sanus Farmaceutica |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | Maximum Plasma Concentration (Cmax) of medroxyprogesterone acetate | Determination of maximum plasma concentration of medroxyprogesterone acetate on plasma concentrations of samples obtained. | 0 - 1008 hours after drug administration | |
Secondary | Maximum Plasma Concentration (Cmax) of estradiol cypionate | Determination of maximum plasma concentration of estradiol cypionate on plasma concentrations of samples obtained. | 0 - 1008 hours after drug administration | |
Secondary | Area Under the Curve (AUC) of medroxyprogesterone acetate | Determination of area Under the Curve of medroxyprogesterone acetate from plasma concentrations versus time curve of samples obtained. | 0 - 1008 hours after drug administration | |
Secondary | Area Under the Curve (AUC) of estradiol cypionate | Determination of area Under the Curve of estradiol cypionate from plasma concentrations versus time curves of samples obtained. | 0 - 1008 hours after drug administration | |
Secondary | Number of adverse events per participant | Number of adverse events, in each treatment group, including clinically relevant alterations of vital signs and laboratory tests results. | Up to 1008 hours after drug administration |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02577601 -
Impact of Combined Hormonal Contraceptives on UPA
|
Phase 4 | |
Completed |
NCT03153644 -
Improving Contraceptive Care for Women With Medical Conditions
|
||
Completed |
NCT04112095 -
Adherence With Continuous-dose Oral Contraceptive: Evaluation of Self-Selection and Use
|
Phase 3 | |
Recruiting |
NCT05521646 -
Implementing Best Practice Postpartum Contraceptive Services Through a Quality Improvement Initiative
|
N/A | |
Active, not recruiting |
NCT04291001 -
Ovarian Function With ENG Implant and UPA Use
|
Early Phase 1 | |
Completed |
NCT04568980 -
Assessment of Contraceptive Safety and Effectiveness in Cystic Fibrosis
|
||
Completed |
NCT03438682 -
Real World Effectiveness and Safety of Hysteroscopic (Essure®) Compared to Laparoscopic Sterilization
|
||
Active, not recruiting |
NCT01948882 -
Evaluation of Safety and Effectiveness of the Essure (Model ESS505) Device to Prevent Pregnancy in Women
|
N/A | |
Enrolling by invitation |
NCT04997499 -
Adolescent Subcutaneous (SQ) Injection Video Validation
|
N/A | |
Recruiting |
NCT03589040 -
Darunavir and Rilpivirine Interactions With Etonogestrel Contraceptive Implant
|
Phase 2 | |
Completed |
NCT04463680 -
Rifampin and the Contraceptive Implant
|
Phase 4 | |
Completed |
NCT03154125 -
Sayana® Press Extension Study
|
Phase 3 | |
Withdrawn |
NCT03725358 -
A Cluster-RCT to Increase the Uptake of LARCs Among Adolescent Females and Young Women in Cameroon.
|
N/A | |
Completed |
NCT02957630 -
"E4/DRSP Endocrine Function, Metabolic Control and Hemostasis Study"
|
Phase 1/Phase 2 | |
Completed |
NCT02456584 -
Pharmacodynamics and Pharmacokinetics Study of Existing DMPA Contraceptive Methods
|
Phase 1 | |
Completed |
NCT02718222 -
Impact and Performance of Institutionalizing Immediate Post-partum IUD Services
|
N/A | |
Recruiting |
NCT02121067 -
LNG-IUS at 2 Weeks Postpartum
|
Phase 4 | |
Terminated |
NCT02169869 -
Immediate Postplacental IUD Insertion
|
N/A | |
Recruiting |
NCT02292056 -
Medication Safety and Contraceptive Counseling for Reproductive Aged Women With Psychiatric Conditions
|
N/A | |
Withdrawn |
NCT01930994 -
Kenya Sino-implant (II) PK Study
|
N/A |