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 range40 Years – 65 Years

SexFEMALE

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…

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 range40 Years – 65 Years

SexFEMALE

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