Drospirenone Only Pills and Cervical Mucus Changes: A Pre- and Post-Bariatric Surgery Study
NCT ID: NCT06345586
Last Updated: 2024-08-14
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
NA
Total Enrollment
16 participants
Study Classification
INTERVENTIONAL
Study Start Date
2024-04-18
Study Completion Date
2025-04-30
Brief Summary
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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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Detailed Description
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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.
Conditions
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Contraception
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Participants received Drospirenone will be assess for cervical mucus change by modified Insler score
Primary Study Purpose
BASIC_SCIENCE
Blinding Strategy
NONE
Study Groups
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Drospirenone
Participants received Drospirenone 4 mg tablet orally once daily for 21-28 days
Group Type
EXPERIMENTAL
Drospirenone
Intervention Type
DRUG
4 mg tablet once daily
Interventions
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Drospirenone
4 mg tablet once daily
Intervention Type
DRUG
Eligibility Criteria
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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
* 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
* 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
Minimum Eligible Age
18 Years
Maximum Eligible Age
45 Years
Eligible Sex
FEMALE
Accepts Healthy Volunteers
No
Sponsors
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Chulalongkorn University
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Punyawee Utaipatanacheep
Role: PRINCIPAL_INVESTIGATOR
Chulalongkorn University
Locations
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Chulalongkorn University
Bangkok, , Thailand
Site Status
RECRUITING
Countries
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Thailand
Central Contacts
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Facility Contacts
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Punyawee Utaipatanacheep
Role: primary
References
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Techagumpuch A, Pantanakul S, Chansaenroj P, Boonyagard N, Wittayapairoch J, Poonthananiwatkul T, et al. Thai Society for metabolic and bariatric surgery consensus guideline on bariatric surgery for the treatment of obese patient in Thailand. JAGST 2021;4:5-18.
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ACOG practice bulletin no. 105: bariatric surgery and pregnancy. Obstet Gynecol. 2009 Jun;113(6):1405-1413. doi: 10.1097/AOG.0b013e3181ac0544. No abstract available.
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United Nations Department of Economic and Social Affairs, Population Division (2022). World Contraceptive Use 2022 [Internet]. [cited 9 August 2023]. Available from: https://www.un.org/development/desa/pd/data/world-contraceptive-use.
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RESULT
Cardiovascular disease and use of oral and injectable progestogen-only contraceptives and combined injectable contraceptives. Results of an international, multicenter, case-control study. World Health Organization Collaborative Study of Cardiovascular Disease and Steroid Hormone Contraception. Contraception. 1998 May;57(5):315-24.
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RESULT
Vasilakis C, Jick H, del Mar Melero-Montes M. Risk of idiopathic venous thromboembolism in users of progestagens alone. Lancet. 1999 Nov 6;354(9190):1610-1. doi: 10.1016/S0140-6736(99)04394-9.
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RESULT
WHO Guidelines Approved by the Guidelines Review Committee. Medical Eligibility Criteria for Contraceptive Use. 5 ed. Geneva: World Health Organization Copyright © World Health Organization 2015.; 2015. p. 156-85.
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RESULT
Curtis KM, Tepper NK, Jatlaoui TC, Berry-Bibee E, Horton LG, Zapata LB, Simmons KB, Pagano HP, Jamieson DJ, Whiteman MK. U.S. Medical Eligibility Criteria for Contraceptive Use, 2016. MMWR Recomm Rep. 2016 Jul 29;65(3):1-103. doi: 10.15585/mmwr.rr6503a1.
Reference Type
RESULT
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.
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RESULT
Palacios S, Regidor PA, Colli E, Skouby SO, Apter D, Roemer T, Egarter C, Nappi RE, Skrivanek A, Jakimiuk AJ, Weyers S, Acs N, Elia D, Gemzell Danielsson K, Bitzer J. Oestrogen-free oral contraception with a 4 mg drospirenone-only pill: new data and a review of the literature. Eur J Contracept Reprod Health Care. 2020 Jun;25(3):221-227. doi: 10.1080/13625187.2020.1743828. Epub 2020 Apr 21.
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RESULT
Creinin MD, Angulo A, Colli E, Archer DF. The efficacy, safety, and tolerability of an estrogen-free oral contraceptive drospirenone 4 mg (24/4-day regimen) in obese users. Contraception. 2023 Dec;128:110136. doi: 10.1016/j.contraception.2023.110136. Epub 2023 Aug 5.
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RESULT
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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. 2015;20(6):419-27. doi: 10.3109/13625187.2015.1044082. Epub 2015 Jun 15.
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RESULT
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.2022.03.016. Epub 2022 Mar 31.
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RESULT
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RESULT
Trevor G Cooper. WHO laboratory manual for the Examination and processing of human semen.5th ed. Switzerland: WHO; 2010. Appendix 5, Cervical mucus; p. 245-53.
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Reference Type
RESULT
Other Identifiers
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078066
Identifier Type: -
Identifier Source: org_study_id
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