Pharmacokinetics of Drospirenone Only Pills in Obese Thai Women: A Pre- and Post-Bariatric Surgery Study

077766

The purpose of this study is to investigate whether bariatric surgery affects Drospirenone only pills absorption

2024-04-01

2025-04-01

2025-04-01

Not yet recruiting

Early phase I

16

Inclusion Criteria: * Thai women aged 18-45 years who are obese and had an appointment for Bariatric surgery at Chulalongkorn Hospital * Need contraception * Able to use non-hormonal contraception during the study * Giving consent Exclusion Criteria: * Pregnancy or history of giving birth within 3 months * Breastfeeding within the 6 months * History of using DMPA within 12 months * History of using other types of hormonal birth control pills within 4 weeks * History of bilateral oophorectomy or hysterectomy * Suspected ovarian tumor or pathological ovarian cyst * Regular cigarette smoking * Contraindications to Drospirenone

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Pre-bariatric surgery pharmacokinetics study of Drospirenone compare with post-bariatric surgery', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 16, 'type': 'ESTIMATED'}}

2024-04-03