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Completed

NCT Number: NCT01087879

The Effect of Hormonal Contraceptives on Androgens and Glucose Metabolism

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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Key information

Conditions

Contraception

Age range

20 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Obstetrics and Gynaecology, University of Oulu

Oulu, 90014, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Mercilon

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.

Other names: NuvaRing

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.

Other names: Evra

Primary outcomes

  1. Androgen secretion

    Time frame: 0, 5, 9, 10 weeks

    Analysis of androstenedione, testosterone and DHEAS from fasting serum samples.

  2. Protein secretion from liver

    Time frame: 0, 5, 9, 10 weeks

    Analysis of SHBG and high sensitivy CRP from fasting serum samples.

Secondary outcomes

  1. Glucose metabolism

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Oulu

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Mar 16, 2010
Registry last updated
Sep 7, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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