Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Lexicon Pharmaceuticals
Age
18–45
Sex
FEMALE
Healthy volunteers
Accepted
You may be eligible 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 be 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
