Completed
PHASE1
INTERVENTIONAL
NCT03798197
Effect of Food on the Bioavailability of 30 mg Estetrol (E4) Tablet in Healthy Postmenopausal Female Volunteers
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief 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.
Interventions
Name:
30 mg estetrol (E4)
Type:
DRUG
Description:
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).
Primary Outcomes
Measure:
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
Description:
PK sampling
Measure:
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
Description:
PK sampling
Measure:
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
Description:
PK sampling
Trial Information
NCT ID
NCT03798197
Status
Completed
Study Type
INTERVENTIONAL
Phases
PHASE1
Sponsor
Donesta Bioscience
Last Updated
December 15, 2025