Oral Contraceptive DDI Study
Status unconfirmed · Phase 1
Conditions studied: Healthy
In brief
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.
Key facts
- Study ID
- NCT02494609
- Run by
- Lexicon Pharmaceuticals
- People needed
- 30
- Starts
- 2015-07-01
- Last updated by the study team
- 2016-03-02
Who can join
Age: 18 and older, up to 45. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- Premenopausal females with a body mass index (BMI) between 18 and 32 kg/m2 (inclusive)
- Have not received any oral contraceptives during the Screening period or for at least 15 days prior to the first dose of Period 1
You may not qualify if…
- History of any contraindications to the combined oral contraceptive tablet including thrombosis and the history of any thromboembolic disease, recurrent jaundice, acute or chronic liver disease, hormonally-induced migraines, undiagnosed vaginal bleeding, significant hyperlipidemia, and mammary, endometrial, or hepatic carcinoma (known or suspected)
- Prior exposure to sotagliflozin (LX4211)
- History of any clinically relevant psychiatric, renal, hepatic, pancreatic, endocrine, cardiovascular, neurological, hematological, or GI abnormality
- Concurrent conditions that could interfere with safety and/or tolerability measurements
- Women who are breastfeeding or are planning to become pregnant during the study
- Positive serum pregnancy test
- Have taken injectable contraceptives or hormonal intrauterine devices within 12 months prior to the first dose of Period 1 or topical controlled delivery contraceptives (patch) for 3 months prior to the first dose of Period 1
Where it is running
- Lexicon Investigational Site — Evansville, Indiana, United States
- Lexicon Investigational Site — Dallas, Texas, United States
Full record on ClinicalTrials.gov
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