Synthetic vs Natural Estrogen in Combined Oral Contraception
NCT ID: NCT02352090
Last Updated: 2023-06-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
59 participants
INTERVENTIONAL
2015-04-01
2018-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Synthetic estrogen + progestin
Ethinyl estradiol / dienogest
Ethinyl estradiol / dienogest
One tablet orally for 9 weeks, continuous use
Natural estrogen + progestin
Estradiol valerate / dienogest
Estradiol valerate / dienogest
One tablet orally for 9 weeks, continuous use
Progestin-Only
Dienogest
Dienogest
One tablet orally for 9 weeks, continuous use
Interventions
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Ethinyl estradiol / dienogest
One tablet orally for 9 weeks, continuous use
Estradiol valerate / dienogest
One tablet orally for 9 weeks, continuous use
Dienogest
One tablet orally for 9 weeks, continuous use
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
35 Years
FEMALE
Yes
Sponsors
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Oulu University Hospital
OTHER
Helsinki University Central Hospital
OTHER
Responsible Party
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Annina Haverinen
MD
Principal Investigators
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Oskari Heikinheimo, Prof., PhD., MD.
Role: STUDY_CHAIR
Helsinki University Central Hospital, Department of Gynecology and Obstetrics. Helsinki Univeristy, Medical Faculty
Juha Tapanainen, Prof., PhD, MD.
Role: STUDY_CHAIR
Helsinki University Central Hospital, Department of Gynecology and Obstetrics. Helsinki Univeristy, Medical Faculty
Terhi Piltonen, PhD, MD
Role: PRINCIPAL_INVESTIGATOR
Oulu University Hospital, Department of Gynecology and Obstetrics
Annina Haverinen, MD, PhD student
Role: PRINCIPAL_INVESTIGATOR
Helsinki University Central Hospital, Department of Gynecology and Obstetrics. Helsinki University, Faculty of Medicine
Locations
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Helsinki University Central Hospital, Kätilöopisto Maternity Hospital
Helsinki, , Finland
Oulu University Hospital, Department of Gynecology and Obstetrics
Oulu, , Finland
Countries
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References
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Kangasniemi MH, Arffman RK, Joenvaara S, Haverinen A, Luiro K, Tohmola T, Renkonen R, Heikinheimo O, Tapanainen JS, Piltonen TT. Ethinylestradiol in combined hormonal contraceptive has a broader effect on serum proteome compared with estradiol valerate: a randomized controlled trial. Hum Reprod. 2023 Jan 5;38(1):89-102. doi: 10.1093/humrep/deac250.
Kangasniemi MH, Arffman RK, Haverinen A, Luiro K, Hustad S, Heikinheimo O, Tapanainen JS, Piltonen TT. Effects of estradiol- and ethinylestradiol-based contraceptives on adrenal steroids: A randomized trial. Contraception. 2022 Dec;116:59-65. doi: 10.1016/j.contraception.2022.08.009. Epub 2022 Sep 7.
Haverinen AH, Luiro KM, Szanto T, Kangasniemi MH, Hiltunen L, Sainio S, Piltonen TT, Lassila R, Tapanainen JS, Heikinheimo O. Combined oral contraceptives containing estradiol valerate vs ethinylestradiol on coagulation: A randomized clinical trial. Acta Obstet Gynecol Scand. 2022 Oct;101(10):1102-1111. doi: 10.1111/aogs.14428. Epub 2022 Jul 31.
Kangasniemi MH, Haverinen A, Luiro K, Hiltunen JK, Komsi EK, Arffman RK, Heikinheimo O, Tapanainen JS, Piltonen TT. Estradiol Valerate in COC Has More Favorable Inflammatory Profile Than Synthetic Ethinyl Estradiol: A Randomized Trial. J Clin Endocrinol Metab. 2020 Jul 1;105(7):dgaa186. doi: 10.1210/clinem/dgaa186.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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SYLVI030785
Identifier Type: -
Identifier Source: org_study_id
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