Effects of bariatric surgery on Drospirenone pill absorption
Pharmacokinetics of Drospirenone Only Pills in Obese Thai Women: A Pre- and Post-Bariatric Surgery Study
This study is testing how bariatric surgery affects how well Drospirenone birth control pills work in obese women.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 16 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Chulalongkorn University Academic / other |
| Locations | 1 site (Bangkok) |
| Trial ID | NCT06345560 on ClinicalTrials.gov |
What this trial studies
This study investigates how bariatric surgery impacts the absorption of Drospirenone-only pills in obese women. Participants will take the pills daily, and their pharmacokinetics will be measured before and after the surgery. The goal is to understand any changes in how the body processes the medication due to surgical weight loss. This could provide important insights into contraceptive effectiveness in this population.
Who should consider this trial
Good fit: Ideal candidates are Thai women aged 18-45 who are obese and scheduled for bariatric surgery, requiring contraception.
Not a fit: Patients who are pregnant, breastfeeding, or have contraindications to Drospirenone will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve contraceptive options and effectiveness for women undergoing bariatric surgery.
How similar studies have performed: While studies on pharmacokinetics in bariatric surgery patients exist, this specific focus on Drospirenone is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Bangkok
- Chulalongkorn University — Bangkok, Thailand (Recruiting)
Study contacts
- Principal investigator: Punyawee Utaipatanacheep — Chulalongkorn University
- Study coordinator: Punyawee Utaipatanacheep
- Email: punyawee@docchula.com
- Phone: +668-7515-4003
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.