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NCT Number: NCT06345560

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

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

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Key information

Conditions

Contraception Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Chulalongkorn University

Bangkok, 10330, Thailand

Location status: Recruiting

Location contact

Punyawee Utaipatanacheep

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Drospirenone

Drug

4 mg tablet once daily

Primary outcomes

  1. Plasma concentration versus Time of Drospirenone

    Time frame: 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 outcomes

  1. Number of Participants With Treatment-Related Adverse Events

    Time frame: 1 month

Study contacts

Contact information is provided by the study sponsor or research team.

Punyawee Utaipatanacheep

CONTACT

[email protected]

+668-7515-4003

Somsook Santibenchakul

CONTACT

[email protected]

+669-2265-7273

Sponsors and collaborators

Lead sponsor

Chulalongkorn University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 3, 2024
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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