Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2026-03-05 @ 1:00 PM
Study NCT ID:
NCT06345560
Status:
RECRUITING
Last Update Posted:
2024-08-14
First Post:
2024-03-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetics of Drospirenone Only Pills: A Pre- and Post-Bariatric Surgery Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C035144', 'term': 'drospirenone'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Pre-bariatric surgery pharmacokinetics study of Drospirenone compare with post-bariatric surgery'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 16}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2025-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-13', 'studyFirstSubmitDate': '2024-03-28', 'studyFirstSubmitQcDate': '2024-03-28', 'lastUpdatePostDateStruct': {'date': '2024-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasma concentration versus Time of Drospirenone', 'timeFrame': '1 month before and 1 month after bariatric surgery', 'description': 'Plasma concentration of Drospirenone will be measured at 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8 hours post-dose'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Treatment-Related Adverse Events', 'timeFrame': '1 month'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Drospirenone only pills', 'Obesity', 'Bariatric surgery', 'Roux-en-Y gastric bypass', 'Pharmacokinetics', 'Absorption'], 'conditions': ['Contraception']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': '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.'}, {'type': 'RESULT', 'citation': '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.'}, {'pmid': '19461456', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '31493139', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '32202076', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '29634911', 'type': 'RESULT', 'citation': '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.'}, {'type': 'RESULT', 'citation': '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.'}, {'pmid': '11245554', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '7500750', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '7500749', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '36103980', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '9673838', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '10560680', 'type': 'RESULT', 'citation': '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.'}, {'type': 'RESULT', 'citation': '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.'}, {'pmid': '27467196', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '33008401', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '32312141', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '37544572', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '26232513', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '28433989', 'type': 'RESULT', 'citation': 'Schlatter J. Oral Contraceptives after Bariatric Surgery. Obes Facts. 2017;10(2):118-126. doi: 10.1159/000449508. Epub 2017 Apr 22.'}, {'pmid': '7068318', 'type': 'RESULT', 'citation': 'Andersen AN, Lebech PE, Sorensen TI, Borggaard B. Sex hormone levels and intestinal absorption of estradiol and D-norgestrel in women following bypass surgery for morbid obesity. Int J Obes. 1982;6(1):91-6.'}, {'pmid': '2449395', 'type': 'RESULT', 'citation': 'Victor A, Odlind V, Kral JG. Oral contraceptive absorption and sex hormone binding globulins in obese women: effects of jejunoileal bypass. Gastroenterol Clin North Am. 1987 Sep;16(3):483-91.'}, {'pmid': '11433905', 'type': 'RESULT', 'citation': 'Weiss HG, Nehoda H, Labeck B, Hourmont K, Marth C, Aigner F. Pregnancies after adjustable gastric banding. Obes Surg. 2001 Jun;11(3):303-6. doi: 10.1381/096089201321336647.'}, {'pmid': '12841897', 'type': 'RESULT', 'citation': 'Gerrits EG, Ceulemans R, van Hee R, Hendrickx L, Totte E. Contraceptive treatment after biliopancreatic diversion needs consensus. Obes Surg. 2003 Jun;13(3):378-82. doi: 10.1381/096089203765887697.'}, {'pmid': '30347490', 'type': 'RESULT', 'citation': 'Ginstman C, Frisk J, Carlsson B, Arlemalm A, Hagg S, Brynhildsen J. Plasma concentrations of etonogestrel in women using oral desogestrel before and after Roux-en-Y gastric bypass surgery: a pharmacokinetic study. BJOG. 2019 Mar;126(4):486-492. doi: 10.1111/1471-0528.15511. Epub 2018 Nov 16.'}, {'pmid': '33547015', 'type': 'RESULT', 'citation': 'Moreira de Brito C, de Melo ME, Mancini MC, Santo MA, Cercato C. Pharmacokinetics of oral levonorgestrel and ethinylestradiol in women after Roux-en-Y gastric bypass surgery. Surg Obes Relat Dis. 2021 Apr;17(4):673-681. doi: 10.1016/j.soard.2020.12.007. Epub 2020 Dec 16.'}, {'type': 'RESULT', 'citation': 'UK Medical Eligibility Criteria For Contraceptive Use UKMEC 2016 (amended September 2019). UK: the Faculty of Sexual and Reproductive Healthcare; 2019.'}, {'pmid': '36316023', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '31758920', 'type': 'RESULT', 'citation': 'Richter WH, Koytchev R, Kirkov V, Merki G, Colli E, Regidor PA. Comparative pharmacokinetic estimates of drospirenone alone and in combination with ethinyl estradiol after single and repeated oral administration in healthy females. Contraception. 2020 Feb;101(2):137-143. doi: 10.1016/j.contraception.2019.10.005. Epub 2019 Nov 21.'}, {'pmid': '3450848', 'type': 'RESULT', 'citation': 'Schuirmann DJ. A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. J Pharmacokinet Biopharm. 1987 Dec;15(6):657-80. doi: 10.1007/BF01068419.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate whether bariatric surgery affects Drospirenone only pills absorption', 'detailedDescription': '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). Between the 21st and 28th day of Drospirenone taking, pharmacokinetics will be measured. Pre-bariatric surgery pharmacokinetics study will be compared with post-bariatric surgery pharmacokinetics study.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Thai women aged 18-45 years who are obese and had an appointment for Bariatric surgery at Chulalongkorn Hospital\n* Need contraception\n* Able to use non-hormonal contraception during the study\n* Giving consent\n\nExclusion Criteria:\n\n* Pregnancy or history of giving birth within 3 months\n* Breastfeeding within the 6 months\n* History of using DMPA within 12 months\n* History of using other types of hormonal birth control pills within 4 weeks\n* History of bilateral oophorectomy or hysterectomy\n* Suspected ovarian tumor or pathological ovarian cyst\n* Regular cigarette smoking\n* Contraindications to Drospirenone'}, 'identificationModule': {'nctId': 'NCT06345560', 'briefTitle': 'Pharmacokinetics of Drospirenone Only Pills: A Pre- and Post-Bariatric Surgery Study', 'organization': {'class': 'OTHER', 'fullName': 'Chulalongkorn University'}, 'officialTitle': 'Pharmacokinetics of Drospirenone Only Pills in Obese Thai Women: A Pre- and Post-Bariatric Surgery Study', 'orgStudyIdInfo': {'id': '077766'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Drospirenone', 'description': 'Participants received Drospirenone 4 mg tablet orally once daily for 21-28 days', 'interventionNames': ['Drug: Drospirenone']}], 'interventions': [{'name': 'Drospirenone', 'type': 'DRUG', 'description': '4 mg tablet once daily', 'armGroupLabels': ['Drospirenone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10330', 'city': 'Bangkok', 'status': 'RECRUITING', 'country': 'Thailand', 'contacts': [{'name': 'Punyawee Utaipatanacheep', 'role': 'CONTACT'}], 'facility': 'Chulalongkorn University', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'centralContacts': [{'name': 'Punyawee Utaipatanacheep', 'role': 'CONTACT', 'email': 'punyawee@docchula.com', 'phone': '+668-7515-4003'}, {'name': 'Somsook Santibenchakul', 'role': 'CONTACT', 'email': 'dr.somsook@gmail.com', 'phone': '+669-2265-7273'}], 'overallOfficials': [{'name': 'Punyawee Utaipatanacheep', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chulalongkorn University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Currently have no recruited participants. You can ask for information directly from the investigators in future.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chulalongkorn University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}