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The Effect of Hormonal Contraceptives on Androgens and Glucose Metabolism

This study has been completed.
Information provided by:
University of Oulu Identifier:
First received: March 15, 2010
Last updated: September 6, 2011
Last verified: September 2011

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.

Condition Intervention
Drug: Desogestrel-Ethinyl Estradiol contraceptive pill
Drug: Etonogestrel-Ethinyl Estradiol vaginal ring
Drug: Norelgestromin-Ethinyl Estradiol contraceptive patch

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Impact of Different Administration Routes of Hormonal Contraceptives on Androgen Synthesis, Glucose Metabolism and Inflammation. A Prospective Randomized Trial.

Resource links provided by NLM:

Further study details as provided by University of Oulu:

Primary Outcome Measures:
  • Androgen secretion [ Time Frame: 0, 5, 9, 10 weeks ]
    Analysis of androstenedione, testosterone and DHEAS from fasting serum samples.

  • Protein secretion from liver [ Time Frame: 0, 5, 9, 10 weeks ]
    Analysis of SHBG and high sensitivy CRP from fasting serum samples.

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 45
Study Start Date: October 2007
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Oral contraceptive pill
9 weeks treatment with contraceptive pill.
Drug: Desogestrel-Ethinyl Estradiol contraceptive pill
150 microg Desogestrel and 20 microg Ethinyl Estradiol combination. One pill once a day for 9 weeks, continual administration.
Other Name: Mercilon
Active Comparator: Contraception vaginal ring
9 weeks treatment with vaginal ring.
Drug: Etonogestrel-Ethinyl Estradiol vaginal ring
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 Name: NuvaRing
Active Comparator: Transdermal contraceptive patch
9 weeks treatment with a transdermal contraceptive patch.
Drug: Norelgestromin-Ethinyl Estradiol contraceptive patch
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 Name: Evra

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.


Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01087879

Department of Obstetrics and Gynaecology, University of Oulu
Oulu, Finland, 90014
Sponsors and Collaborators
University of Oulu
Study Chair: Juha S. Tapanainen, Professor Dept Ob-Gyn, University of Oulu
Study Director: Terhi T. Piltonen, MD Dept Ob-Gyn, University of Oulu
Principal Investigator: Johanna M. Puurunen, MD Dept Ob-Gyn, Univeristy of Oulu
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Terhi Piltonen/M.D., Ph.D., Dept Ob-Gyn, University of Oulu Identifier: NCT01087879     History of Changes
Other Study ID Numbers: 191/2006
Study First Received: March 15, 2010
Last Updated: September 6, 2011

Keywords provided by University of Oulu:
oral glucose tolerance test
hormonal contraception

Additional relevant MeSH terms:
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol valerate
Contraceptive Agents
Ethinyl Estradiol
Polyestradiol phosphate
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Hormones, Hormone Substitutes, and Hormone Antagonists
Progestins processed this record on April 28, 2017