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The impact of different administration routes of hormonal contraceptives on androgen secretion, glucose metabolism and inflammation. A prospective randomized trial.
The investigators assume, that transdermal or transvaginal hormonal contraception would have less effects on androgen levels, glucose metabolism and inflammatory markers than oral contraceptives.
45 patients are recruited in the study. Each study group will consist of 15 women (aged 20-35 years) receiving oral, transdermal or transvaginal hormonal contraception continuously for 9 weeks. The subjects should have at least 2 months wash out period from all hormonal medication prior to the study.
The measurements for serum sampling and OGTT will be performed before and after 9 weeks of medication.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral contraceptive pill | Active Comparator | 9 weeks treatment with contraceptive pill. |
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| Contraception vaginal ring | Active Comparator | 9 weeks treatment with vaginal ring. |
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| Transdermal contraceptive patch | Active Comparator | 9 weeks treatment with a transdermal contraceptive patch. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Desogestrel-Ethinyl Estradiol contraceptive pill | Drug | 150 microg Desogestrel and 20 microg Ethinyl Estradiol combination. One pill once a day for 9 weeks, continual administration. |
| Measure | Description | Time Frame |
|---|---|---|
| Androgen secretion | Analysis of androstenedione, testosterone and DHEAS from fasting serum samples. | 0, 5, 9, 10 weeks |
| Protein secretion from liver | Analysis of SHBG and high sensitivy CRP from fasting serum samples. | 0, 5, 9, 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Glucose metabolism | Oral glucose tolerance test at 0 and 9 weeks. Fasting glucose, insulin and c-peptid at 5 and 10 weeks. | 0, (5), 9, (10) weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Juha S. Tapanainen, Professor | Dept Ob-Gyn, University of Oulu | Study Chair |
| Terhi T. Piltonen, MD | Dept Ob-Gyn, University of Oulu | Study Director |
| Johanna M. Puurunen, MD | Dept Ob-Gyn, Univeristy of Oulu | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Obstetrics and Gynaecology, University of Oulu | Oulu | 90014 | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23260855 | Derived | 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. | |
| 22811306 | Derived | 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. |
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| ID | Term |
|---|---|
| C442659 | ethinyl estradiol-desogestrel combination |
| C516519 | NuvaRing |
| C511292 | Ortho Evra |
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| Etonogestrel-Ethinyl Estradiol vaginal ring | Drug | 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. |
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| Norelgestromin-Ethinyl Estradiol contraceptive patch | Drug | 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. |
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