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

NCT03798197 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2019-05-07

No results posted yet for this study

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.

Conditions

  • Food-effect

Interventions

DRUG

30 mg estetrol (E4)

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).

Sponsors & Collaborators

  • Donesta Bioscience

    lead INDUSTRY

Principal Investigators

  • Dobrin Svinarov, MD · MC Comac Medical Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-01-30
Primary Completion
2019-04-06
Completion
2019-04-06

Countries

  • Bulgaria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03798197 on ClinicalTrials.gov