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

Sponsor
Chulalongkorn University
Study ID
NCT06345560
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Contraception

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 45 Years
Healthy Volunteers
Not accepted

Interventions

  • Drospirenone — DRUG
    4 mg tablet once daily

Study Details

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

Key Dates

First listed
Apr 3, 2024
Start date
Apr 18, 2024
Status verified
Mar 2026
Primary completion
Jul 31, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
16 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

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

Primary Outcome Measure

Plasma concentration versus Time of Drospirenone [ Time Frame: 1 month before and 1 month after bariatric surgery ]

Central Contacts

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