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

Not Applicable

Recruiting

• Conditions: Contraception
• Interventions: Drug: Drospirenone

• Registration Number: NCT06345586
• Lead Sponsor: Chulalongkorn University

Brief Summary

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

Detailed 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). 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.

Study Timeline

• Status Verified: 2024-03
• Study First Submitted: 2024-03-28
• Study First Submitted QC: 2024-03-28
• Study First Posted: 2024-04-03
• Study Start: 2024-04-18
• Last Update Submitted: 2024-08-12
• Last Update Posted: 2024-08-14
• Primary Completion: 2025-04
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 16

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Cervical mucus by modified Insler score	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 Outcome Measures

Name	Time	Method
Number of Participants With Treatment-Related Adverse Events	1 month
Estrogen and progesterone levels versus time	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

Trial Locations

Locations (1)

Chulalongkorn University; 🇹🇭 Bangkok, Thailand