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

Chulalongkorn University

Status: Enrolling

Conditions: Contraception

Treatments: Drug: Drospirenone

Study type: Interventional

Funder types: Other

Identifiers

NCT06345586

078066

Details and patient eligibility

About

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

Full 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.

Enrollment: 16 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

Drospirenone

Experimental group

Description:

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

Treatment:

Drug: Drospirenone