Pharmacokinetics of Drospirenone Only Pills: A Pre- and Post-Bariatric Surgery Study
NCT ID: NCT06345560
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
RECRUITING
Clinical Phase
PHASE1/PHASE2
Total Enrollment
16 participants
Study Classification
INTERVENTIONAL
Study Start Date
2024-04-18
Study Completion Date
2025-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The purpose of this study is to investigate whether bariatric surgery affects Drospirenone only pills absorption
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Drospirenone Only Pills and Cervical Mucus Changes: A Pre- and Post-Bariatric Surgery Study
NCT06345586
Contraception
RECRUITING
NA
Low Dose OC Therapy in Women With Polycystic Ovary Syndrome (PCOS): Impact of BMI on Hyperandrogenism
NCT01360996
Polycystic Ovary Syndrome
COMPLETED
PHASE4
Study of Pharmacodynamics of LIK066 in Overweight and Obese Women With Polycystic Ovary Syndrome
NCT03152591
Polycystic Ovary Syndrome
COMPLETED
PHASE2
Role of Insulin Action and Free Fatty Acids in Hyperandrogenism of Women With Polycystic Ovary Syndrome
NCT01019356
Polycystic Ovary Syndrome
COMPLETED
NA
The Effect of Weight Loss on Anti-Müllerian Hormone Levels in Women With Polycystic Ovary Syndrome (PCOS)
NCT01475019
Obesity
Polycystic Ovaries Syndrome
UNKNOWN
PHASE4
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Contraception
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
NA
Intervention Model
SINGLE_GROUP
Pre-bariatric surgery pharmacokinetics study of Drospirenone compare with post-bariatric surgery
Primary Study Purpose
BASIC_SCIENCE
Blinding Strategy
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Drospirenone
4 mg tablet once daily
Intervention Type
DRUG
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
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
Meet the organizations funding or collaborating on the study and learn about their roles.
Chulalongkorn University
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Responsibility Role
SPONSOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Punyawee Utaipatanacheep
Role: PRINCIPAL_INVESTIGATOR
Chulalongkorn University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Chulalongkorn University
Bangkok, , Thailand
Site Status
RECRUITING
Countries
Review the countries where the study has at least one active or historical site.
Thailand
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Punyawee Utaipatanacheep
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
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.
Reference Type
RESULT
UK Medical Eligibility Criteria For Contraceptive Use UKMEC 2016 (amended September 2019). UK: the Faculty of Sexual and Reproductive Healthcare; 2019.
Reference Type
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
RESULT
Schlatter J. Oral Contraceptives after Bariatric Surgery. Obes Facts. 2017;10(2):118-126. doi: 10.1159/000449508. Epub 2017 Apr 22.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
077766
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Reproductive Hormonal Alterations in Obesity
NCT01457703
COMPLETED
NA
Evaluation of Anti-mullerian Hormone(AMH) Levels as a Predictive Factor of Response to Weight Loss Treatment in Obese Infertile Women With Poly Cystic Ovary(PCOS)
NCT01792362
COMPLETED
PHASE3
Studying the Starvation Effect on Androgen Metabolism in 20 Healthy Young Women and Comparison to Women With PCOS.
NCT03573063
COMPLETED
NA
Ovarian Hyperstimulation Syndrome and Cabergoline
NCT01569256
COMPLETED
NA
Dietary Reversal of the Reprometabolic Syndrome
NCT07227766
ACTIVE_NOT_RECRUITING
NA
A 6-month Observational Study on Combined Oral Contraceptives and Body Weight in Pre-Menopausal Women With Overweight or Obesity
NCT05061472
COMPLETED
The Gut Microbiome in Women With Polycystic Ovary Syndrome
NCT03642600
COMPLETED
PHASE4
Lifestyle Factors Study
NCT00989183
COMPLETED
The Effect of Dipeptidyl Peptidase 4 Inhibition on Growth Hormone Secretion in Women With Polycystic Ovarian Syndrome
NCT02122380
COMPLETED
PHASE4
Role of Nesfatin-1 and Nicotinamide in Infertile Women With Polycystic Ovary Syndrome
NCT03870035
UNKNOWN
Body Fat as Determinant of Female Gonadal Dysfunction
NCT03841981
RECRUITING
Subcutaneous Adipose Tissue in Cases With Polycystic Ovarian Syndrome
NCT01310569
COMPLETED
Oral Contraceptive and Cardiovascular Risk in PCOS
NCT00593294
COMPLETED
PHASE4
Phlebotomy and Polycystic Ovary Syndrome
NCT02460445
COMPLETED
NA
OVERWEIGHT AND OBESITY ADVERSELY AFFECT IVF OUTCOMES IN WOMEN WITH PCOS
NCT03120286
COMPLETED
Dampening the Reproductive Axis With Continuous Kisspeptin
NCT05971849
COMPLETED
PHASE1
The Effects of the Mediterranean Diet and Synbiotics in Polycystic Ovary Syndrome
NCT07342946
NOT_YET_RECRUITING
NA
Absorption and Tolerability Studies of an Emulsion Containing the Coconut Oil-derived Glycerol Tridecanoate in Healthy Men
NCT03255889
WITHDRAWN
PHASE1
Effects of Interleukin-1 Receptor Antagonism on Hyperandrogenemia in Women With Polycystic Ovary Syndrome
NCT03578497
COMPLETED
PHASE2
The Efficacy of Progestins in Treatment of Functional Ovarian Cyst
NCT03456570
UNKNOWN
EARLY_PHASE1
Advanced Glycation End Products and Dietary Intervention in Polycystic Ovary Patients
NCT05830487
UNKNOWN
NA
Evaluation of Serum Prostatic Specific Antigen (PSA) After Cyproterone Compound Treatment Compared With Oral Contraceptives Pill in Hirsute Polycystic Ovary Syndrome Patients
NCT00955058
UNKNOWN
PHASE2/PHASE3
Effects of Alpha-acid Lipoic in PCOS Women
NCT02666170
UNKNOWN
NA
Epicardial Adipose Tissue Thickness in Polycystic Ovary Syndrome (PCOS)
NCT01258946
COMPLETED
A Study of Safety and Efficacy of Tildacerfont in Females With Polycystic Ovary Syndrome and Elevated Adrenal Androgens
NCT05370521
TERMINATED
PHASE2