Food-effectPhase 1NCT03798197
Effect of Food on the Bioavailability of 30 mg Estetrol (E4) Tablet in Healthy Postmenopausal Female Volunteers
A Phase 1 study testing 30 mg estetrol (E4) in people with Food-effect, run by Donesta Bioscience at 1 site in Bulgaria.
Trial summary
Assessment of the effect of a high fat meal on the quantity in blood of a female sex hormone called estetrol (E4). The study also aims at determining how subject tolerate the study drug and how safe it is for them. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Food-effect
- What is being tested?
- 30 mg estetrol (E4)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteBulgaria
- Study dates
- 30 Jan 2019to 6 Apr 2019
- 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 40 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Overtly healthy postmenopausal females as determined by medical history, physical examination including breast examination, gynecological examination, cervical smear (Pap smear) if subject has cervix, vital signs, and laboratory tests performed within 28 days before first study drug intake.
- Between the ages of 40 and 65 years inclusive at the time of signing the informed consent (IC).
- Between the Body Mass Index (BMI) of 18 and 30 kg/m2 inclusive and body weight ≥ 45 kg.
- For non-hysterectomized women: intact uterus with bi-layer endometrial thickness ≤ 5 mm on transvaginal ultrasound (TVUS).
- Non-smokers.
- Negative test results for selected drugs of abuse and cotinine.
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- Venous access sufficient to allow blood sampling as per the protocol.
- Subject is able to understand and comply with the protocol requirements, instructions, and protocol-stated restrictions.
- Subject has provided signed and dated written IC before participation in the study.
Who cannot join
- For non-hysterectomized women: uterine disease or medical condition including:
- Bi-layer endometrial thickness >5mm as determined by TVUS;
- Presence of fibroid(s) that obscure(s) evaluation of endometrium by TVUS;
- History or presence of uterine cancer;
- Presence of any significant uterine, ovarian or other adnexa related abnormality as determined by TVUS;
- Presence of an endometrial polyp.
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- Undiagnosed vaginal bleeding in the last 12 months.
- Any history of malignancy.
- History of venous or arterial thromboembolic disease
- Abnormal blood pressure.
- Use of :
- Any prescription drugs within 28 days prior to the first study dose administration.
- Any over-the-counter (OTC) medication or dietary supplements (vitamins included) within 14 days prior to the first study dose administration.
- Users of progestin implants or oestrogen alone injectable drug therapy are not allowed to participate unless treatment was stopped more than 3 months prior to screening.
- Users of oestrogen pellet or progestin injectable drug therapy are not allowed to participate unless treatment was stopped more than 6 months prior to screening.
- Subjects who are not in euthyroid condition.
- History of hypersensitivity or existing contraindication to E4 or intolerance to any component of the formulations or test meal.
- Presence or history of gallbladder disease, unless cholecystectomy has been performed.
- Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the subject in case of participation in the study.
- History or presence of immunodeficiency diseases including a positive human immunodeficiency virus (HIV) test result, positive hepatitis B surface antigen (HBsAg) or hepatitis C test result.
- History of illicit drug or alcohol abuse within 12 months prior to first study dose or evidence of such abuse as indicated by laboratory values within 28 days prior to first study dose.
- Consumption of foods or beverages containing the following products during the specified timeframes prior to study drug administration in Period 1: caffeine or xanthine - 48 hours; alcohol - 48 hours; grapefruit/seville orange/citrus fruit and/or star fruit - 7 days. Others Fruit juices: 72 hours prior to study drug administration.
- Donation or loss of
- ≥ 450 mL blood within 1 month prior to initial study drug administration.
- ≥ 250 mL blood within 2 weeks prior to initial study drug administration.
- Sponsor, Contract Research Organization (CRO) or Investigator's site personnel or their relatives directly affiliated with this study.
- History or presence of clinically relevant disease of any major system organ class (SOC) (e.g. cardiovascular, pulmonary, renal, hepatic, gastrointestinal, reproductive, endocrinological, neurological, psychiatric or orthopedic disease) as judged by the Investigator.
- Previous completion or withdrawal from this study.
- Participation in another investigational drug clinical study within 1 month (30 days) or have received an investigational drug within the last 3 months (90 days) prior to study entry.
- Is judged by the Investigator to be unsuitable for any reason.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Single-center, Randomized, Two Period, Two Sequence Crossover Study to Characterize the Effect of Food on the Bioavailability of 30 mg Estetrol (E4) Tablet in Healthy Postmenopausal Female Volunteers
Assessment of the effect of a high fat meal on the quantity in blood of a female sex hormone called estetrol (E4).
The study also aims at determining how subject tolerate the study drug and how safe it is for them.
- Conditions
- Food-effect
- Being tested
- 30 mg estetrol (E4)
- Keywords
- Estetrol, Menopausal hormone therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
30 mg estetrol (E4)Drug
Also called 30 mg E4 tablet
All subjects received both Treatment A and Treatment B either at the first treatment period (Period 1) or at 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 |
|---|---|---|
| 30 mg estetrol (E4) without food (fasted) | Active comparator | Treatment A (reference): One 30 mg E4 tablet administered orally following an overnight fast of at least 10 hours. Receives: Drug: 30 mg estetrol (E4) |
| 30 mg estetrol (E4) with food (fed) | Experimental | Treatment B (test): One 30 mg E4 tablet administered orally 30 min after the start of an FDA prescribed high-fat breakfast preceded by at least a 10 hours overnight fast. Receives: Drug: 30 mg estetrol (E4) |
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: Predose, 10, 20, 30, 45 min, 1, 1.25, 1.5, 1.75, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 hours post-dose
Area under the curve (AUC) from time zero to the last determinable concentration of Estetrol
PK sampling
Measured: Predose, 10, 20, 30, 45 min, 1, 1.25, 1.5, 1.75, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 hours post-dose
AUC0-inf of Estetrol
PK sampling
Measured: Predose, 10, 20, 30, 45 min, 1, 1.25, 1.5, 1.75, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 hours post-dose
Secondary outcomes (4)
Time of Cmax (Tmax)
PK sampling
Measured: Predose, 10, 20, 30, 45 min, 1, 1.25, 1.5, 1.75, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 hours post-dose
Terminal phase rate constant (ke)
PK sampling
Measured: Predose, 10, 20, 30, 45 min, 1, 1.25, 1.5, 1.75, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 hours post-dose
Terminal half-life (t1/2)
PK sampling
Measured: Predose, 10, 20, 30, 45 min, 1, 1.25, 1.5, 1.75, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 hours post-dose
Number of subjects with adverse events as measure of safety and tolerability
Measured: From Day 28 prior screening to end of study (Day 4 of Period 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2019
- Study start30 Jan 2019
- Primary completion6 Apr 2019
- Study completion6 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food-effectStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Donesta Bioscience
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dobrin Svinarov, MD, Principal investigator, MC Comac Medical Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03798197
- Sponsor's protocol ID
- MIT-Do001-C101
- Other IDs
- 2018-003761-34, 2018
- Status last verified
- May 2019
- First submitted
- 7 Jan 2019
- Last updated
- 7 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single-center, Randomized, Two Period, Two Sequence Crossover Study to Characterize the Effect of Food on the Bioavailability of 30 mg Estetrol (E4) Tablet in Healthy Postmenopausal Female Volunteers
- ClinicalTrials.gov ID
- NCT03798197
- Acronym / sponsor ID
- MIT-Do001-C101
- Conditions
- Food-effect
- Keywords
- Estetrol, Menopausal hormone therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Donesta BioscienceIndustry (pharma, biotech, devices)
- Study start
- 30 Jan 2019 (actual)
- Primary completion
- 6 Apr 2019 (actual)
- Study completion
- 6 Apr 2019 (actual)
- First posted
- 9 Jan 2019 (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.
Assessment of the effect of a high fat meal on the quantity in blood of a female sex hormone called estetrol (E4).
The study also aims at determining how subject tolerate the study drug and how safe it is for them.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 30 mg estetrol (E4) without food (fasted) | Active comparator | Drug: 30 mg estetrol (E4)Treatment A (reference): One 30 mg E4 tablet administered orally following an overnight fast of at least 10 hours. |
| 30 mg estetrol (E4) with food (fed) | Experimental | Drug: 30 mg estetrol (E4)Treatment B (test): One 30 mg E4 tablet administered orally 30 min after the start of an FDA prescribed high-fat breakfast preceded by at least a 10 hours overnight fast. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Overtly healthy postmenopausal females as determined by medical history, physical examination including breast examination, gynecological examination, cervical smear (Pap smear) if subject has cervix, vital signs, and laboratory tests performed within 28 days before first study drug intake.
- Between the ages of 40 and 65 years inclusive at the time of signing the informed consent (IC).
- Between the Body Mass Index (BMI) of 18 and 30 kg/m2 inclusive and body weight ≥ 45 kg.
- For non-hysterectomized women: intact uterus with bi-layer endometrial thickness ≤ 5 mm on transvaginal ultrasound (TVUS).
- Non-smokers.
Key exclusion criteria (30 listed)
- For non-hysterectomized women: uterine disease or medical condition including:
- Undiagnosed vaginal bleeding in the last 12 months.
- Any history of malignancy.
- History of venous or arterial thromboembolic disease
- Abnormal blood pressure.
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 |
|---|---|---|
| 30 mg estetrol (E4)Also: 30 mg E4 tabletAll subjects received both Treatment A and Treatment B either at the first treatment period (Period 1) or at 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 | 30 mg estetrol (E4) with food (fed), 30 mg estetrol (E4) without food (fasted) |
Primary outcome
Maximum concentration (Cmax) of Estetrol in plasma
Time frame: Predose, 10, 20, 30, 45 min, 1, 1.25, 1.5, 1.75, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 hours post-dose
PK sampling
Area under the curve (AUC) from time zero to the last determinable concentration of Estetrol
Time frame: Predose, 10, 20, 30, 45 min, 1, 1.25, 1.5, 1.75, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 hours post-dose
PK sampling
AUC0-inf of Estetrol
Time frame: Predose, 10, 20, 30, 45 min, 1, 1.25, 1.5, 1.75, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 hours post-dose
PK sampling
4 secondary outcomes
Time of Cmax (Tmax)
Time frame: Predose, 10, 20, 30, 45 min, 1, 1.25, 1.5, 1.75, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 hours post-dose
Terminal phase rate constant (ke)
Time frame: Predose, 10, 20, 30, 45 min, 1, 1.25, 1.5, 1.75, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 hours post-dose
Terminal half-life (t1/2)
Time frame: Predose, 10, 20, 30, 45 min, 1, 1.25, 1.5, 1.75, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 hours post-dose
Number of subjects with adverse events as measure of safety and tolerability
Time frame: From Day 28 prior screening to end of study (Day 4 of 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 7 May 2019.
- 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 Svinarov, MD principal investigator
MC Comac Medical Ltd.
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 30 mg estetrol (E4) in people with Food-effect, run by Donesta Bioscience at 1 site in Bulgaria.
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 9 inclusion and 30 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 7 May 2019. 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 Bulgaria. 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?
Maximum concentration (Cmax) of Estetrol in plasma (time frame: Predose, 10, 20, 30, 45 min, 1, 1.25, 1.5, 1.75, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 hours post-dose). The study lists 3 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 7 May 2019.