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

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

Status

Recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06345560

Enrollment

Registered

2024-04-03

Start date

2024-04-18

Completion date

2026-07-01

Last updated

2026-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Contraception

Keywords

Drospirenone only pills, Obesity, Bariatric surgery, Roux-en-Y gastric bypass, Pharmacokinetics, Absorption

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.

Interventions

DRUGDrospirenone

4 mg tablet once daily

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Intervention model description

Pre-bariatric surgery pharmacokinetics study of Drospirenone compare with post-bariatric surgery

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame
Number of Participants With Treatment-Related Adverse Events	1 month

Countries

Thailand

Contacts

CONTACTPunyawee Utaipatanacheep

punyawee@docchula.com+668-7515-4003

CONTACTSomsook Santibenchakul

dr.somsook@gmail.com+669-2265-7273

PRINCIPAL_INVESTIGATORPunyawee Utaipatanacheep

Chulalongkorn University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 20, 2026