Clinical trial NCT01087879: The Effect of Hormonal Contraceptives on Androgens and Glucose Metabolism
Official title: The Impact of Different Administration Routes of Hormonal Contraceptives on Androgen Synthesis, Glucose Metabolism and Inflammation. A Prospective Randomized Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contraception
Keywords: oral glucose tolerance test
hormonal contraception
androgens
crp
Lead sponsor: University of Oulu
Sponsor class: OTHER
First posted: 2010-03-16
Enrollment: 45
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Androgen secretion
timeFrame: 0, 5, 9, 10 weeks
measure: Protein secretion from liver
timeFrame: 0, 5, 9, 10 weeks
Secondary outcomes:
measure: Glucose metabolism
timeFrame: 0, (5), 9, (10) weeks
Other outcomes:
Locations:
city: Oulu
country: Finland
facility: Department of Obstetrics and Gynaecology, University of Oulu
Study officials:
affiliation: Dept Ob-Gyn, University of Oulu
name: Juha S. Tapanainen, Professor
role: STUDY_CHAIR
affiliation: Dept Ob-Gyn, University of Oulu
name: Terhi T. Piltonen, MD
role: STUDY_DIRECTOR
affiliation: Dept Ob-Gyn, Univeristy of Oulu
name: Johanna M. Puurunen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.