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Effect of Food on the Bioavailability of 15 mg Estetrol/3 mg Drospirenone Tablets in Healthy Female Volunteers

NCT02852681 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2016-08-02

No results posted yet for this study

Summary

This single-center, open-label, randomized, balanced, single-dose, two-treatment, two-period, two-sequence crossover study was conducted under medical supervision in 28 healthy female volunteers.

Conditions

  • Contraception

Interventions

DRUG

15 mg E4/3 mg DRSP

All subjects received both Treatment A and Treatment B either at the first treatment period (Period 1) or 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

  • Estetra

    lead INDUSTRY

Principal Investigators

  • Dobrin Sviranov, MD · Comac Medical

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2015-10-31
Completion
2016-04-30

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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 NCT02852681 on ClinicalTrials.gov