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Estetrol (E4)/Drospirenone (DRSP) Drug-drug Interaction (DDI) Study

NCT03512860 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2018-12-14

No results posted yet for this study

Summary

The present study is designed to determine the effect of valproic acid (VAL), a UGT2B7 inhibiting drug, on the pharmacokinetics (PK) of estetrol (E4)

Conditions

  • Contraception

Interventions

DRUG

E4/DRSP

Administered as specified in the treatment arm.

DRUG

VAL

Administered as specified in the treatment arm.

Sponsors & Collaborators

  • Quotient Sciences

    collaborator INDUSTRY

  • Estetra

    lead INDUSTRY

Principal Investigators

  • Sharan Sidhu · Quotient Sciences

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2018-04-12
Primary Completion
2018-10-08
Completion
2018-10-08

Countries

  • United Kingdom

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 NCT03512860 on ClinicalTrials.gov