The Effect of Hormonal Contraceptives on Androgens and Glucose Metabolism

NCT01087879 — Not applicable, Completed, 45 participants, University of Oulu

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The Impact of Different Administration Routes of Hormonal Contraceptives on Androgen Synthesis, Glucose Metabolism and Inflammation. A Prospective Randomized Trial.

Registry	NCT01087879
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, single group, masking: none, treatment
Enrollment	45 (Estimated)
Sponsor	University of Oulu (Other)
Conditions	Contraception
Interventions	Desogestrel-Ethinyl Estradiol contraceptive pill, Etonogestrel-Ethinyl Estradiol vaginal ring, Norelgestromin-Ethinyl Estradiol contraceptive patch (Drug)
Dates	start 2007-10-01, primary completion 2011-01-01, completion 2011-01-01, first posted 2010-03-16, last updated 2011-09-07
Locations	1 site in Finland

-Summary

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.

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+Detailed description

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.

+Arms and interventions

Arm	Type	Interventions	Description
Oral contraceptive pill	Active comparator	Drug: Desogestrel-Ethinyl Estradiol contraceptive pill	9 weeks treatment with contraceptive pill.
Contraception vaginal ring	Active comparator	Drug: Etonogestrel-Ethinyl Estradiol vaginal ring	9 weeks treatment with vaginal ring.
Transdermal contraceptive patch	Active comparator	Drug: Norelgestromin-Ethinyl Estradiol contraceptive patch	9 weeks treatment with a transdermal contraceptive patch.

Desogestrel-Ethinyl Estradiol contraceptive pill (Drug), also known as Mercilon: 150 microg Desogestrel and 20 microg Ethinyl Estradiol combination. One pill once a day for 9 weeks, continual administration.
Etonogestrel-Ethinyl Estradiol vaginal ring (Drug), also known as NuvaRing: 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 (Drug), also known as Evra: 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.

+Outcome measures

Primary outcomes

Androgen secretion [0, 5, 9, 10 weeks]: Analysis of androstenedione, testosterone and DHEAS from fasting serum samples.
Protein secretion from liver [0, 5, 9, 10 weeks]: Analysis of SHBG and high sensitivy CRP from fasting serum samples.

Secondary outcomes

Glucose metabolism [0, (5), 9, (10) weeks]: Oral glucose tolerance test at 0 and 9 weeks. Fasting glucose, insulin and c-peptid at 5 and 10 weeks.

+Eligibility

Sex: Female, ages: 20 Years to 35 Years, accepts healthy volunteers

Inclusion Criteria:

* healthy women aged from 20 to 35 years
* regular menstruation
* no use of hormonal contraception or two months wash-out period
* no contraindications for using hormonal contraception

Exclusion Criteria:

* irregular menstruation
* 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

+Locations (1)

Facility	City	Country	Status
Department of Obstetrics and Gynaecology, University of Oulu	Oulu	Finland

+Publications

Results publication: 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. PMID 23260855
Results publication: 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. PMID 22811306

+Investigators

Juha S. Tapanainen, Professor, Study chair, Dept Ob-Gyn, University of Oulu
Terhi T. Piltonen, MD, Study director, Dept Ob-Gyn, University of Oulu
Johanna M. Puurunen, MD, Principal investigator, Dept Ob-Gyn, Univeristy of Oulu