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

ConditionContraception

Trial statusRecruiting

Trial phasePhase 1, Phase 2

Trial typeInterventional

Biological sexFemale

Age18-45

SponsorChulalongkorn University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

Drospirenone
Drug
4 mg tablet once daily

Treatment groups

16 Participants

are divided into 1 treatment group

Group A: DrospirenoneExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Plasma concentration versus Time of Drospirenone

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

Time frame

1 month before and 1 month after bariatric surgery

Secondary outcomes

Number of Participants With Treatment-Related Adverse Events

Time frame

1 month

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chulalongkorn University

Lead sponsor

Source ClinicalTrials.gov

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