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NCT Number: NCT06345586

Drospirenone Only Pills and Cervical Mucus Changes: A Pre- and Post-Bariatric Surgery Study

The purpose of this study is to study the effect of Drospirenone on cervical mucus change by modified Insler score, pre-bariatric surgery and post-bariatric surgery

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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

Not applicable

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). Cervical mucus by modified Insler score will be evaluated on Day 4-7 of Drospirenone taking. Pre-bariatric surgery results will be compared with post-bariatric surgery results.

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. Cervical mucus by modified Insler score

    Time frame: 1 month before and 1 month after bariatric surgery

    Modified Insler score (ferning, spinnbarkeit, viscosity, cellularity) according to the World Health Organization (WHO) guidelines 2010 used for prediction and detection of ovulation.

    Score ≥9 favoring fertility, 5-8 intermediate, and ≤4 unfavorable to fertility Comparing pre-bariatric surgery with post-bariatric surgery

Secondary outcomes

  1. Estrogen and progesterone levels versus time

    Time frame: 1 month before and 1 month after bariatric surgery

    Serum estrogen and progesterone levels will be measured to evaluate change over time (pattern and value) and assess ovulation

  2. 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

Drospirenone Only Pills and Cervical Mucus Changes 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 18, 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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