CompletedPhase 1

Effect of Food on the Bioavailability of 30 mg Estetrol (E4) Tablet in Healthy Postmenopausal Female Volunteers

Bulgaria28 participantsStarted 2019-01-30

Plain-language 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.

Who can participate

Age range

40 Years – 65 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. * 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. Exclusion Criteria: * 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. * Undiagnosed vaginal bleeding in the last 12 months. * Any history of mali…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Maximum concentration (Cmax) of Estetrol in plasma

Timeframe: 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

Timeframe: 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

Timeframe: 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

Trial details

NCT IDNCT03798197

SponsorDonesta Bioscience

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-04-06

View on ClinicalTrials.gov More Food-effect trials

Who can participate

Age range

40 Years – 65 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Maximum concentration (Cmax) of Estetrol in plasma

Timeframe: 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

Timeframe: 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

Timeframe: 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