The Effect of Hormonal Contraceptives on Androgens and Glucose Metabolism
NCT ID: NCT01087879
Last Updated: 2011-09-07
Study Results
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.
COMPLETED
NA
45 participants
INTERVENTIONAL
2007-10-31
2011-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The investigators assume, that transdermal or transvaginal hormonal contraception would have less effects on androgen levels, glucose metabolism and inflammatory markers than oral contraceptives.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Synthetic vs Natural Estrogen in Combined Oral Contraception
NCT02352090
Transdermal Contraceptive Patch - Endometrial Effects Study
NCT00896571
Investigation of Three Contraceptive Hormone Patches in Regard to Inhibition of Ovulation Following Application Over 3 Treatment Cycles in Healthy, Young Women.
NCT01204190
Oral Versus Patch Hormonal Contraceptive Effects on Metabolism, Clotting, Inflammatory Factors and Vascular Reactivity
NCT00439972
FC Patch Low: Metabolism Study
NCT00933179
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The measurements for serum sampling and OGTT will be performed before and after 9 weeks of medication.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Oral contraceptive pill
9 weeks treatment with contraceptive pill.
Desogestrel-Ethinyl Estradiol contraceptive pill
150 microg Desogestrel and 20 microg Ethinyl Estradiol combination. One pill once a day for 9 weeks, continual administration.
Contraception vaginal ring
9 weeks treatment with vaginal ring.
Etonogestrel-Ethinyl Estradiol vaginal ring
Etonogestrel-Ethinyl Estradiol vaginal ring, which consists of 11,7 mg etonogestrel and 2,7 mg ethinyl estradiol. It delivers 0,120 mg etonogestrel and 0,015 mg ethinyl estradiol per day. Treatment continues continual for 9 weeks and the vaginal ring is changed every three weeks.
Transdermal contraceptive patch
9 weeks treatment with a transdermal contraceptive patch.
Norelgestromin-Ethinyl Estradiol contraceptive patch
A combination transdermal contraceptive patch with 6 mg of norelgestromin and 600 microg of ethinyl estradiol. It delivers 203 microg of norelgestromin and 33,9 microg ethinyl estradiol per day. A continual use of patch for 9 weeks and the patch is changed every week.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Desogestrel-Ethinyl Estradiol contraceptive pill
150 microg Desogestrel and 20 microg Ethinyl Estradiol combination. One pill once a day for 9 weeks, continual administration.
Etonogestrel-Ethinyl Estradiol vaginal ring
Etonogestrel-Ethinyl Estradiol vaginal ring, which consists of 11,7 mg etonogestrel and 2,7 mg ethinyl estradiol. It delivers 0,120 mg etonogestrel and 0,015 mg ethinyl estradiol per day. Treatment continues continual for 9 weeks and the vaginal ring is changed every three weeks.
Norelgestromin-Ethinyl Estradiol contraceptive patch
A combination transdermal contraceptive patch with 6 mg of norelgestromin and 600 microg of ethinyl estradiol. It delivers 203 microg of norelgestromin and 33,9 microg ethinyl estradiol per day. A continual use of patch for 9 weeks and the patch is changed every week.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* regular menstruation
* no use of hormonal contraception or two months wash-out period
* no contraindications for using hormonal contraception
Exclusion Criteria
* smoking
* alcohol addiction
* pregnancy or nursing
* hypersensitivity to any components of the products
* headaches with focal neurological symptoms
* serious or multiple risk factors for artery disease
* undiagnosed abnormal genital bleeding
* impaired glucose tolerance or DM-T2
20 Years
35 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Oulu
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Dept Ob-Gyn, University of Oulu
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Juha S. Tapanainen, Professor
Role: STUDY_CHAIR
Dept Ob-Gyn, University of Oulu
Terhi T. Piltonen, MD
Role: STUDY_DIRECTOR
Dept Ob-Gyn, University of Oulu
Johanna M. Puurunen, MD
Role: PRINCIPAL_INVESTIGATOR
Dept Ob-Gyn, Univeristy of Oulu
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Department of Obstetrics and Gynaecology, University of Oulu
Oulu, , Finland
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Kallio S, Puurunen J, Ruokonen A, Vaskivuo T, Piltonen T, Tapanainen JS. Antimullerian hormone levels decrease in women using combined contraception independently of administration route. Fertil Steril. 2013 Apr;99(5):1305-10. doi: 10.1016/j.fertnstert.2012.11.034. Epub 2012 Dec 20.
Piltonen T, Puurunen J, Hedberg P, Ruokonen A, Mutt SJ, Herzig KH, Nissinen A, Morin-Papunen L, Tapanainen JS. Oral, transdermal and vaginal combined contraceptives induce an increase in markers of chronic inflammation and impair insulin sensitivity in young healthy normal-weight women: a randomized study. Hum Reprod. 2012 Oct;27(10):3046-56. doi: 10.1093/humrep/des225. Epub 2012 Jul 18.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
191/2006
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.