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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drospirenone | Experimental | Participants received Drospirenone 4 mg tablet orally once daily for 21-28 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Drospirenone | Drug | 4 mg tablet once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Number of Participants With Treatment-Related Adverse Events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Punyawee Utaipatanacheep | Contact | +668-7515-4003 | punyawee@docchula.com | |
| Somsook Santibenchakul | Contact | +669-2265-7273 | dr.somsook@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Punyawee Utaipatanacheep | Chulalongkorn University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chulalongkorn University | Recruiting | Bangkok | 10330 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | 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. | ||
| Result | Simmons K, Edelman A. Contraception in the setting of obesity and bariatric surgery. In: Allen RH, Cwiak CA, editors. Contraception for the medically challenging patient. New York: Springer; 2014. P. 157-80. | ||
| 19461456 | Result | 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. | |
| 31493139 |
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Currently have no recruited participant.
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C035144 | drospirenone |
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Participants received Drospirenone will be assess for cervical mucus change by modified Insler score
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| 1 month |
| Result |
| Ciangura C, Coupaye M, Deruelle P, Gascoin G, Calabrese D, Cosson E, Ducarme G, Gaborit B, Lelievre B, Mandelbrot L, Petrucciani N, Quilliot D, Ritz P, Robin G, Salle A, Gugenheim J, Nizard J; BARIA-MAT Group. Clinical Practice Guidelines for Childbearing Female Candidates for Bariatric Surgery, Pregnancy, and Post-partum Management After Bariatric Surgery. Obes Surg. 2019 Nov;29(11):3722-3734. doi: 10.1007/s11695-019-04093-y. |
| 32202076 | Result | Mechanick JI, Apovian C, Brethauer S, Timothy Garvey W, Joffe AM, Kim J, Kushner RF, Lindquist R, Pessah-Pollack R, Seger J, Urman RD, Adams S, Cleek JB, Correa R, Figaro MK, Flanders K, Grams J, Hurley DL, Kothari S, Seger MV, Still CD. Clinical Practice Guidelines for the Perioperative Nutrition, Metabolic, and Nonsurgical Support of Patients Undergoing Bariatric Procedures - 2019 Update: Cosponsored by American Association of Clinical Endocrinologists/American College of Endocrinology, The Obesity Society, American Society for Metabolic and Bariatric Surgery, Obesity Medicine Association, and American Society of Anesthesiologists. Obesity (Silver Spring). 2020 Apr;28(4):O1-O58. doi: 10.1002/oby.22719. |
| 29634911 | Result | Mengesha BM, Carter JT, Dehlendorf CE, Rodriguez AJ, Steinauer JE. Perioperative pregnancy interval, contraceptive counseling experiences, and contraceptive use in women undergoing bariatric surgery. Am J Obstet Gynecol. 2018 Jul;219(1):81.e1-81.e9. doi: 10.1016/j.ajog.2018.04.008. Epub 2018 Apr 7. |
| Result | 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. |
| 11245554 | Result | Nightingale AL, Lawrenson RA, Simpson EL, Williams TJ, MacRae KD, Farmer RD. The effects of age, body mass index, smoking and general health on the risk of venous thromboembolism in users of combined oral contraceptives. Eur J Contracept Reprod Health Care. 2000 Dec;5(4):265-74. doi: 10.1080/13625180008500402. |
| 7500750 | Result | Jick H, Jick SS, Gurewich V, Myers MW, Vasilakis C. Risk of idiopathic cardiovascular death and nonfatal venous thromboembolism in women using oral contraceptives with differing progestagen components. Lancet. 1995 Dec 16;346(8990):1589-93. doi: 10.1016/s0140-6736(95)91928-7. |
| 7500749 | Result | Effect of different progestagens in low oestrogen oral contraceptives on venous thromboembolic disease. World Health Organization Collaborative Study of Cardiovascular Disease and Steroid Hormone Contraception. Lancet. 1995 Dec 16;346(8990):1582-8. |
| 36103980 | Result | Rosano GMC, Rodriguez-Martinez MA, Spoletini I, Regidor PA. Obesity and contraceptive use: impact on cardiovascular risk. ESC Heart Fail. 2022 Dec;9(6):3761-3767. doi: 10.1002/ehf2.14104. Epub 2022 Sep 14. |
| 9673838 | 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. |
| 10560680 | 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. |
| 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. |
| 27467196 | 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. |
| 33008401 | 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. |
| 32312141 | 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. |
| 37544572 | 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. |
| 26232513 | Result | Archer DF, Ahrendt HJ, Drouin D. Drospirenone-only oral contraceptive: results from a multicenter noncomparative trial of efficacy, safety and tolerability. Contraception. 2015 Nov;92(5):439-44. doi: 10.1016/j.contraception.2015.07.014. Epub 2015 Jul 29. |
| 28433989 | Result | Schlatter J. Oral Contraceptives after Bariatric Surgery. Obes Facts. 2017;10(2):118-126. doi: 10.1159/000449508. Epub 2017 Apr 22. |
| 33562977 | Result | Krepelka P. New estrogen-free oral hormonal contraceptive (Estrogene free ill-EFP). Ceska Gynekol. 2020 Winter;85(3):222-225. |
| 26073333 | Result | 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. |
| 35367204 | 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. |
| 5104921 | Result | Moghissi KS, Marks C. Effects of microdose norgestrel on endogenous gonadotropic and steroid hormones, cervical mucus properties, vaginal cytology, and endometrium. Fertil Steril. 1971 Jul;22(7):424-34. doi: 10.1016/s0015-0282(16)38342-x. No abstract available. |
| 36316023 | Result | FSRH Guideline (August 2022) Progestogen-only Pills. BMJ Sex Reprod Health. 2022 Aug;48(Suppl 1):1-75. doi: 10.1136/bmjsrh-2022-PoP. No abstract available. |
| 26405263 | Result | Brache V, Cochon L, Duijkers IJ, Levy DP, Kapp N, Monteil C, Abitbol JL, Klipping C. A prospective, randomized, pharmacodynamic study of quick-starting a desogestrel progestin-only pill following ulipristal acetate for emergency contraception. Hum Reprod. 2015 Dec;30(12):2785-93. doi: 10.1093/humrep/dev241. Epub 2015 Sep 23. |
| 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. |
| 16985015 | Result | Tworoger SS, Hankinson SE. Collection, processing, and storage of biological samples in epidemiologic studies: sex hormones, carotenoids, inflammatory markers, and proteomics as examples. Cancer Epidemiol Biomarkers Prev. 2006 Sep;15(9):1578-81. doi: 10.1158/1055-9965.EPI-06-0629. |
| 11056261 | Result | Taieb J, Benattar C, Birr AS, Lindenbaum A, Frydman R, Olivennes F. Delayed assessment of serum and whole blood estradiol, progesterone, follicle-stimulating hormone, and luteinizing hormone kept at room temperature or refrigerated. Fertil Steril. 2000 Nov;74(5):1053-4. doi: 10.1016/s0015-0282(00)01546-6. No abstract available. |
| 12633759 | Result | Jane Ellis M, Livesey JH, Evans MJ. Hormone stability in human whole blood. Clin Biochem. 2003 Mar;36(2):109-12. doi: 10.1016/s0009-9120(02)00440-x. |
| 35351445 | Result | Glasier A, Edelman A, Creinin MD, Han L, Matulich MC, Brache V, Westhoff CL, Hemon A. Mechanism of action of norgestrel 0.075 mg a progestogen-only pill. I. Effect on ovarian activity. Contraception. 2022 Aug;112:37-42. doi: 10.1016/j.contraception.2022.03.022. Epub 2022 Mar 26. |
| 6418326 | Result | Wathen NC, Perry L, Lilford RJ, Chard T. Interpretation of single progesterone measurement in diagnosis of anovulation and defective luteal phase: observations on analysis of the normal range. Br Med J (Clin Res Ed). 1984 Jan 7;288(6410):7-9. doi: 10.1136/bmj.288.6410.7. |
| 6770571 | Result | Landgren BM, Unden AL, Diczfalusy E. Hormonal profile of the cycle in 68 normally menstruating women. Acta Endocrinol (Copenh). 1980 May;94(1):89-98. doi: 10.1530/acta.0.0940089. No abstract available. |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |