ContraceptionPhase 1NCT03443089
Comparative Bioavailability of Two Injectable Suspension Formulations of Medroxyprogesterone Acetate+Estradiol Cypionate
A Phase 1 study testing Test formulation and Reference formulation in people with Contraception, run by Galeno Desenvolvimento de Pesquisas Clínicas at 1 site in Brazil.
Trial 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®… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- Test formulation and Reference formulation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteBrazil
- Study dates
- 31 Mar 2017to 1 Aug 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Galeno Desenvolvimento de Pesquisas Clinicas Ltda. - ME
Campinas, São Paulo
About this study
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)
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.
Read the 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 + 5 mg/mL estradiol cypionate, Biolab Sanus Farmacêutica Ltda.) and twelve subjects received the reference product (Cyclofemina®, 25 mg/0.5 mL medroxyprogesterone acetate + 5 mg/0.5 mL estradiol cypionate, Millet Roux Ltda.). The formulations (test or reference) were administered in a single intramuscular dose (1 ampoule) after an overnight fast (approximately 8 h). Blood samples (9 mL) were collected via a venous catheter into heparinized tubes at times pre-dose (0 h) and 6, 12, 24, 48, 72, 96, 120, 168, 240, 288, 336, 432, 504, 672, 840, 1008, 1176, 1344, 1512, 1680, 1848, and 2016 h after drug administration to measure medroxyprogesterone; and pre-dose (-48, -24 and 0 h) e 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 168, 240, 288, 336, 432, 504, 672, 840, and 1008 h after drug administration to measure estradiol cypionate.
The safety assessment was based on recording adverse events throughout the study duration. The subjects systolic and diastolic pressures, heart rate and temperature were determined prior and at approximately 4, 8 and 12 h after drug administration. The clinical evaluation and the laboratory tests were also performed at the end of the study.
- Conditions
- Contraception
- Being tested
- Test formulation, Reference formulation
- Keywords
- medroxyprogesterone acetate, estradiol cypionate, bioavailability, monthly contraceptive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test formulationDrug
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.
Reference formulationDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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.) Receives: 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.) Receives: Drug: Reference formulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: -48 to 1008 hours after drug administration
Secondary outcomes (5)
Maximum Plasma Concentration (Cmax) of medroxyprogesterone acetate
Determination of maximum plasma concentration of medroxyprogesterone acetate on plasma concentrations of samples obtained.
Measured: 0 - 1008 hours after drug administration
Maximum Plasma Concentration (Cmax) of estradiol cypionate
Determination of maximum plasma concentration of estradiol cypionate on plasma concentrations of samples obtained.
Measured: 0 - 1008 hours after drug administration
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.
Measured: 0 - 1008 hours after drug administration
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.
Measured: 0 - 1008 hours after drug administration
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.
Measured: Up to 1008 hours after drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2018
- Study start31 Mar 2017
- Primary completion2 Apr 2017
- Study completion1 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galeno Desenvolvimento de Pesquisas Clínicas
- Sponsor type
- Other government
- Collaborators
- Biolab Sanus Farmaceutica
- Responsible party
- Principal investigator, Gilberto De Nucci, Galeno Desenvolvimento de Pesquisas Clínicas
- Investigators
- Gilberto De Nucci, Doctor, Principal investigator, Galeno Desenvolvimento de Pesquisas Clinicas Ltda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03443089
- Sponsor's protocol ID
- GDN 022/16
- Status last verified
- Feb 2018
- First submitted
- 16 Feb 2018
- Last updated
- 23 Feb 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03443089
- Acronym / sponsor ID
- GDN 022/16
- Conditions
- Contraception
- Keywords
- medroxyprogesterone acetate, estradiol cypionate, bioavailability, monthly contraceptive
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Galeno Desenvolvimento de Pesquisas ClínicasOther government
- Collaborators
- Biolab Sanus Farmaceutica
- Study start
- 31 Mar 2017 (actual)
- Primary completion
- 2 Apr 2017 (actual)
- Study completion
- 1 Aug 2017 (actual)
- First posted
- 22 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 + 5 mg/mL estradiol cypionate, Biolab Sanus Farmacêutica Ltda.) and twelve subjects received the reference product (Cyclofemina®, 25 mg/0.5 mL medroxyprogesterone acetate + 5 mg/0.5 mL estradiol cypionate, Millet Roux Ltda.). The formulations (test or reference) were administered in a single intramuscular dose (1 ampoule) after an overnight fast (approximately 8 h). Blood samples (9 mL) were collected via a venous catheter into heparinized tubes at times pre-dose (0 h) and 6, 12, 24, 48, 72, 96, 120, 168, 240, 288, 336, 432, 504, 672, 840, 1008, 1176, 1344, 1512, 1680, 1848, and 2016 h after drug administration to measure medroxyprogesterone; and pre-dose (-48, -24 and 0 h) e 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 168, 240, 288, 336, 432, 504, 672, 840, and 1008 h after drug administration to measure estradiol cypionate.
The safety assessment was based on recording adverse events throughout the study duration. The subjects systolic and diastolic pressures, heart rate and temperature were determined prior and at approximately 4, 8 and 12 h after drug administration. The clinical evaluation and the laboratory tests were also performed at the end of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test formulation | Experimental | Drug: Test formulationSingle intramuscular dose administration (1 ampoule) of medroxyprogesterone acetate 25 mg/mL+ estradiol cypionate 5 mg/mL (Depomês®, Biolab Sanus Farmacêutica Ltda.) |
| Reference formulation | Active comparator | Drug: Reference formulationSingle intramuscular dose administration (1 ampoule) of medroxyprogesterone acetate 25 mg/ampole + estradiol cypionate 5 mg/ampole (Cyclofemina®, Millet Roux Ltda.) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Test formulationAdministration of a single intramuscular dose of an injectable formulation containing medroxyprogesterone acetate 25 mg/mL + estradiol cypionate 5 mg/mL after an overnight fast. | Drug | Test formulation |
| Reference formulationAdministration of a single intramuscular dose of an injectable formulation containing medroxyprogesterone acetate 25 mg/ampole + estradiol cypionate 5 mg/ampole after an overnight fast. | Drug | Reference formulation |
Primary outcome
Measurement of medroxyprogesterone acetate and estradiol cypionate plasma levels
Time frame: 0-1008 hours after drug administration
Blood sampling for the determination of plasma levels of medroxyprogesterone acetate and estradiol cypionate in participants of each treatment group.
Measurement of estradiol cypionate plasma levels
Time frame: -48 to 1008 hours after drug administration
Blood sampling for the determination of plasma levels of estradiol cypionate in participants of each treatment group.
5 secondary outcomes
Maximum Plasma Concentration (Cmax) of medroxyprogesterone acetate
Time frame: 0 - 1008 hours after drug administration
Maximum Plasma Concentration (Cmax) of estradiol cypionate
Time frame: 0 - 1008 hours after drug administration
Area Under the Curve (AUC) of medroxyprogesterone acetate
Time frame: 0 - 1008 hours after drug administration
Area Under the Curve (AUC) of estradiol cypionate
Time frame: 0 - 1008 hours after drug administration
Number of adverse events per participant
Time frame: Up to 1008 hours after drug administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilberto De Nucci, Doctor principal investigator
Galeno Desenvolvimento de Pesquisas Clinicas Ltda
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Test formulation and Reference formulation in people with Contraception, run by Galeno Desenvolvimento de Pesquisas Clínicas at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of medroxyprogesterone acetate and estradiol cypionate plasma levels (time frame: 0-1008 hours after drug administration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2018.