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

Chulalongkorn University

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Contraception

Treatments: Drug: Drospirenone

Study type: Interventional

Funder types: Other

Identifiers

NCT06345560

077766

Details and patient eligibility

About

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

Full 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.

Enrollment: 16 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No 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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

Drospirenone

Experimental group

Description:

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

Treatment:

Drug: Drospirenone