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Oral Contraceptive DDI Study

NCT02494609 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2016-03-02

No results posted yet for this study

Summary

A Two-way Study to Evaluate the Potential Pharmacokinetic Interactions Between Sotagliflozin (LX4211) and an Oral Contraceptive Containing Norgestimate and Ethinyl Estradiol, in Healthy Premenopausal Women.

Conditions

  • Healthy

Interventions

DRUG

sotagliflozin

400 mg sotagliflozin

DRUG

oral contraceptive

0.25 mg norgestimate/0.035 mg ethinyl estradiol

DRUG

oral contraceptive + sotagliflozin

0.25 mg norgestimate/0.035 mg ethinyl estradiol + 400 mg sotagliflozin

Sponsors & Collaborators

  • Lexicon Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Suman Wason, MD · Lexicon Pharmaceuticals, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2015-11-30

Countries

  • United States

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 NCT02494609 on ClinicalTrials.gov