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

Contraception Clinical Trial

Official title:

Drospirenone Only Pills and Cervical Mucus Changes in Obese Thai Women: A Pre- and Post-Bariatric Surgery Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06345586
• Other study ID #: 078066
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: April 2025

Study information

• Verified date: March 2024
• Source: Chulalongkorn University
• Contact: Punyawee Utaipatanacheep
• Phone: +668-7515-4003
• Email: punyawee[@]docchula.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 16
• Est. completion date: April 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Contraception

Intervention

Drug:
• Drospirenone
4 mg tablet once daily

Locations

Country	Name	City	State
Thailand	Chulalongkorn University	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

References & Publications (33)

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Duijkers IJ, Heger-Mahn D, Drouin D, Skouby S. A randomised study comparing the effect on ovarian activity of a progestogen-only pill (POP) containing desogestrel and a new POP containing drospirenone in a 24/4 regimen. Eur J Contracept Reprod Health Care — View Citation

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Han L, Creinin MD, Hemon A, Glasier A, Chen MJ, Edelman A. Mechanism of action of a 0.075 mg norgestrel progestogen-only pill 2. Effect on cervical mucus and theoretical risk of conception. Contraception. 2022 Aug;112:43-47. doi: 10.1016/j.contraception.2 — View Citation

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Palacios S, Colli E, Regidor PA. Efficacy and cardiovascular safety of the new estrogen-free contraceptive pill containing 4 mg drospirenone alone in a 24/4 regime. BMC Womens Health. 2020 Oct 2;20(1):218. doi: 10.1186/s12905-020-01080-9. — View Citation

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* Note: There are 33 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cervical mucus by modified Insler score	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	1 month before and 1 month after bariatric surgery
Secondary	Estrogen and progesterone levels versus time	Serum estrogen and progesterone levels will be measured to evaluate change over time (pattern and value) and assess ovulation	1 month before and 1 month after bariatric surgery
Secondary	Number of Participants With Treatment-Related Adverse Events		1 month