ContraceptionPhase 1NCT02852681
Effect of Food on the Bioavailability of 15 mg Estetrol/3 mg Drospirenone Tablets in Healthy Female Volunteers
A Phase 1 study testing 15 mg E4/3 mg DRSP in people with Contraception, run by Estetra.
Trial summary
This single-center, open-label, randomized, balanced, single-dose, two-treatment, two-period, two-sequence crossover study was conducted under medical supervision in 28 healthy female volunteers. 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?
- 15 mg E4/3 mg DRSP
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- Aug 2015to Apr 2016
- 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
- Overtly healthy females.
- Between the ages of 18 and 45 years, inclusive.
- Non-smokers who have not used tobacco or nicotine in any form during the 3 months prior to the screening visit.
- Between the body mass index (BMI) of 18 and 30 kg/m2, inclusive, and body weight 45kg.
- Negative serum pregnancy test results at screening and negative urine pregnancy test results before dosing.
- Willing to use double-barrier methods of non-hormonal contraception during the entire study period.
Who cannot join
- Potential study subjects were not entered into and/or may have been discontinued from the study if any of the following applied:
- Use of
- progestogen-only contraceptive methods [e.g., minipill, implant or, intrauterine system (IUS)] during the last 3 months prior to the first dose or,
- depot progestogen preparations or an injectable hormonal method of contraception (e.g., Depo-Provera) during the last 6 months prior to the first dose.
- Use (within 28 days prior to first dose) of other hormonal contraceptive method.
- Use of
- any prescription drugs (except thyroid hormone supplements) or herbal supplements acting on CYP3A4 functions (e.g., St. John's Wort), within 28 days prior to the first dose until study completion,
- any over-the-counter (OTC) medication (including paracetamol) or dietary supplements (vitamins included) within 14 days prior to the first study dose until study completion.
About this study
Official title: A Study to Characterize the Effect of Food on the Bioavailability of 15 mg Estetrol (E4)/3 mg Drospirenone (DRSP) Tablets in Healthy Female Volunteers
This single-center, open-label, randomized, balanced, single-dose, two-treatment, two-period, two-sequence crossover study was conducted under medical supervision in 28 healthy female volunteers.
Read the detailed description
Food effect bioavailability studies are usually conducted for new drugs and drug products to assess the effect of food on the rate and extent of absorption of a drug when the drug product is administered shortly after a meal (fed conditions), as compared to administration under fasting conditions. Therefore, this study was designed to characterize the effect of a high fat meal on the bioavailability of E4 and DRSP after administration of a single tablet containing 15 mg E4 and 3 mg DRSP.
All subjects entered the study site at least 12 hours before each dosing and fasted for at least 10 hours prior to each dose.
All subjects were to receive both Treatment A (Reference; a single 15 mg E4/3 mg DRSP tablet without food (fasted)) and Treatment B (Test; a single 15 mg E4/3 mg DRSP tablet with food (fed)) either at the first treatment period (Period 1) or the second treatment period (Period 2). Approximately half of the subjects were randomized to receive either Treatment A followed by Treatment B (Sequence AB), or Treatment B followed by Treatment A (Sequence BA).
- Conditions
- Contraception
- Being tested
- 15 mg E4/3 mg DRSP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
15 mg E4/3 mg DRSPDrug
Also called 15 mg Estetrol/3 mg Drospirenone
All subjects received both Treatment A and Treatment B either at the first treatment period (Period 1) or the second treatment period (Period 2). Approximately half of the subjects was randomized to receive either Treatment A followed by Treatment B (Sequence AB), or Treatment B followed by Treatment A (Sequence BA)
| Study group | Role | What they receive |
|---|---|---|
| 15 mg E4/3 mg DRSP without food | Other | Treatment A (Reference): a single 15 mg E4/3 mg DRSP tablet without food (fasted). Receives: Drug: 15 mg E4/3 mg DRSP |
| 15 mg E4l/3 mg DRSP with food | Other | Treatment B (Test): a single 15 mg E4/3 mg DRSP tablet with food (fed) Receives: Drug: 15 mg E4/3 mg DRSP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum concentration (Cmax) of estetrol in plasma
PK sampling
Measured: From day 1 to 4 during both period 1 and period 2
Cmax of drospirenone in plasma
PK sampling
Measured: From day 1 to 4 during both period 1 and period 2
Area under the plasma concentration versus time curve from time 0 to the last determined concentration (AUC0-tdlc) of estetrol
Measured: From day 1 to 4 during both period 1 and period 2
AUC0-tdlc of drospirenone
Measured: From day 1 to 4 during both period 1 and period 2
AUC0-inf of estetrol
PK sampling
Measured: Day 1 to 4 during both period 1 and period 2
AUC0-inf of drospirenone
PK sampling
Measured: Day 1 to 4 during both period 1 and period 2
Secondary outcomes (1)
Number of subjects with adverse events as a measure of safety and tolerability
Measured: From up to day 28 before randomization (28 day screening/run-in period) to day 4 of the Period 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2016 (estimated)
- Study startAug 2015
- Primary completionOct 2015
- Study completionApr 2016
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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Estetra
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dobrin Sviranov, MD, Principal investigator, Comac Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02852681
- Sponsor's protocol ID
- Es0001-C101
- Other IDs
- 2015-001764-19, 2015
- Status last verified
- Jun 2016
- First submitted
- 15 Apr 2016
- Last updated
- 2 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Characterize the Effect of Food on the Bioavailability of 15 mg Estetrol (E4)/3 mg Drospirenone (DRSP) Tablets in Healthy Female Volunteers
- ClinicalTrials.gov ID
- NCT02852681
- Acronym / sponsor ID
- Es0001-C101
- Conditions
- Contraception
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- EstetraIndustry (pharma, biotech, devices)
- Study start
- Aug 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 2 Aug 2016 (estimated)
- 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 single-center, open-label, randomized, balanced, single-dose, two-treatment, two-period, two-sequence crossover study was conducted under medical supervision in 28 healthy female volunteers.
Detailed description
Food effect bioavailability studies are usually conducted for new drugs and drug products to assess the effect of food on the rate and extent of absorption of a drug when the drug product is administered shortly after a meal (fed conditions), as compared to administration under fasting conditions. Therefore, this study was designed to characterize the effect of a high fat meal on the bioavailability of E4 and DRSP after administration of a single tablet containing 15 mg E4 and 3 mg DRSP.
All subjects entered the study site at least 12 hours before each dosing and fasted for at least 10 hours prior to each dose.
All subjects were to receive both Treatment A (Reference; a single 15 mg E4/3 mg DRSP tablet without food (fasted)) and Treatment B (Test; a single 15 mg E4/3 mg DRSP tablet with food (fed)) either at the first treatment period (Period 1) or the second treatment period (Period 2). Approximately half of the subjects were randomized to receive either Treatment A followed by Treatment B (Sequence AB), or Treatment B followed by Treatment A (Sequence BA).
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 15 mg E4/3 mg DRSP without food | Other | Drug: 15 mg E4/3 mg DRSPTreatment A (Reference): a single 15 mg E4/3 mg DRSP tablet without food (fasted). |
| 15 mg E4l/3 mg DRSP with food | Other | Drug: 15 mg E4/3 mg DRSPTreatment B (Test): a single 15 mg E4/3 mg DRSP tablet with food (fed) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Overtly healthy females.
- Between the ages of 18 and 45 years, inclusive.
- Non-smokers who have not used tobacco or nicotine in any form during the 3 months prior to the screening visit.
- Between the body mass index (BMI) of 18 and 30 kg/m2, inclusive, and body weight 45kg.
- Negative serum pregnancy test results at screening and negative urine pregnancy test results before dosing.
Key exclusion criteria (8 listed)
- Potential study subjects were not entered into and/or may have been discontinued from the study if any of the following applied:
- Use of
- Use (within 28 days prior to first dose) of other hormonal contraceptive method.
- Use of
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 |
|---|---|---|
| 15 mg E4/3 mg DRSPAlso: 15 mg Estetrol/3 mg DrospirenoneAll subjects received both Treatment A and Treatment B either at the first treatment period (Period 1) or the second treatment period (Period 2). Approximately half of the subjects was randomized to receive either Treatment A followed by Treatment B (Sequence AB), or Treatment B followed by Treatment A (Sequence BA) | Drug | 15 mg E4/3 mg DRSP without food, 15 mg E4l/3 mg DRSP with food |
Primary outcome
Maximum concentration (Cmax) of estetrol in plasma
Time frame: From day 1 to 4 during both period 1 and period 2
PK sampling
Cmax of drospirenone in plasma
Time frame: From day 1 to 4 during both period 1 and period 2
PK sampling
Area under the plasma concentration versus time curve from time 0 to the last determined concentration (AUC0-tdlc) of estetrol
Time frame: From day 1 to 4 during both period 1 and period 2
AUC0-tdlc of drospirenone
Time frame: From day 1 to 4 during both period 1 and period 2
AUC0-inf of estetrol
Time frame: Day 1 to 4 during both period 1 and period 2
PK sampling
AUC0-inf of drospirenone
Time frame: Day 1 to 4 during both period 1 and period 2
PK sampling
1 secondary outcome
Number of subjects with adverse events as a measure of safety and tolerability
Time frame: From up to day 28 before randomization (28 day screening/run-in period) to day 4 of the Period 2
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 2 Aug 2016.
- Individual participant dataSharing planned: No
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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.
Dobrin Sviranov, MD principal investigator
Comac Medical
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 15 mg E4/3 mg DRSP in people with Contraception, run by Estetra.
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 8 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 2 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Maximum concentration (Cmax) of estetrol in plasma (time frame: From day 1 to 4 during both period 1 and period 2). The study lists 6 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 2 Aug 2016.