Clinical trial NCT06345586: Drospirenone Only Pills and Cervical Mucus Changes: A Pre- and Post-Bariatric Surgery Study
Official title: Drospirenone Only Pills and Cervical Mucus Changes in Obese Thai Women: A Pre- and Post-Bariatric Surgery Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Contraception
Keywords: Drospirenone only pills
Obesity
Bariatric surgery
Roux-en-Y gastric bypass
Cervical mucus
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2024-04-03
Enrollment: 16
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Participants received Drospirenone will be assess for cervical mucus change by modified Insler score
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cervical mucus by modified Insler score
timeFrame: 1 month before and 1 month after bariatric surgery
Secondary outcomes:
measure: Estrogen and progesterone levels versus time
timeFrame: 1 month before and 1 month after bariatric surgery
measure: Number of Participants With Treatment-Related Adverse Events
timeFrame: 1 month
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Chulalongkorn University
Study officials:
affiliation: Chulalongkorn University
name: Punyawee Utaipatanacheep
role: PRINCIPAL_INVESTIGATOR
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