Pharmacokinetics of Drospirenone Only Pills: A Pre- and Post-Bariatric Surgery Study

Phase 1

Recruiting

• Conditions: Contraception
• Interventions: Drug: Drospirenone

• Registration Number: NCT06345560
• Lead Sponsor: Chulalongkorn University

Brief Summary

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

Detailed Description

After being informed about the study and potential risks, all participants giving written informed consent who meet the eligibility requirements will take Drospirenone-only pills (4 mg, once daily). Between the 21st and 28th day of Drospirenone taking, pharmacokinetics will be measured. Pre-bariatric surgery pharmacokinetics study will be compared with post-bariatric surgery pharmacokinetics study.

Study Timeline

• Status Verified: 2024-03
• Study First Submitted: 2024-03-28
• Study First Submitted QC: 2024-03-28
• Study First Posted: 2024-04-03
• Study Start: 2024-04-18
• Last Update Submitted: 2024-08-13
• Last Update Posted: 2024-08-14
• Primary Completion: 2025-04
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Drospirenone	Drospirenone	Participants received Drospirenone 4 mg tablet orally once daily for 21-28 days

Primary Outcome Measures

Name	Time	Method
Plasma concentration versus Time of Drospirenone	1 month before and 1 month after bariatric surgery	Plasma concentration of Drospirenone will be measured at 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8 hours post-dose

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Treatment-Related Adverse Events	1 month

Trial Locations

Locations (1)

Chulalongkorn University; 🇹🇭 Bangkok, Thailand