The Effect of Hormonal Contraceptives on Androgens and Glucose Metabolism

Condition(s) targeted: Contraception

Intervention: Desogestrel-Ethinyl Estradiol contraceptive pill (Drug); Etonogestrel-Ethinyl Estradiol vaginal ring (Drug); Norelgestromin-Ethinyl Estradiol contraceptive patch (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: University of Oulu

Official(s) and/or principal investigator(s):
Juha S. Tapanainen, Professor, Study Chair, Affiliation: Dept Ob-Gyn, University of Oulu
Terhi T. Piltonen, MD, Study Director, Affiliation: Dept Ob-Gyn, University of Oulu
Johanna M. Puurunen, MD, Principal Investigator, Affiliation: Dept Ob-Gyn, Univeristy of Oulu

Overall contact:
Juha S. Tapanainen, Professor, Phone: +358-8-3153172, Email: juha.tapanainen@oulu.fi

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.

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

Study design: Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Androgen secretion

Protein secretion from liver

Secondary outcome: Glucose metabolism

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.

Minimum age: 20 Years. Maximum age: 35 Years. Gender(s): Female.

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

Juha S. Tapanainen, Professor, Phone: +358-8-3153172, Email: juha.tapanainen@oulu.fi

Department of Obstetrics and Gynaecology, University of Oulu, Oulu 90014, Finland; Recruiting
Juha S. Tapanainen, Professor, Phone: +358-8-3153172, Email: juha.tapanainen@oulu.fi
Terhi T. Piltonen, M.D., Ph.D., Principal Investigator
Johanna Puurunen, M.D., Principal Investigator
Laure Morin-Papunen, Docent, Sub-Investigator

Starting date: October 2007
Last updated: March 25, 2010