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The Effect of Hormonal Contraceptives on Androgens and Glucose Metabolism

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ClinicalTrials.gov Identifier: NCT01087879
Recruitment Status : Completed
First Posted : March 16, 2010
Last Update Posted : September 7, 2011
Sponsor:
Information provided by:
University of Oulu

Study Description
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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.


Condition or disease Intervention/treatment Phase
Contraception Drug: Desogestrel-Ethinyl Estradiol contraceptive pill Drug: Etonogestrel-Ethinyl Estradiol vaginal ring Drug: Norelgestromin-Ethinyl Estradiol contraceptive patch Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (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.
Study Start Date : October 2007
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01087879


Locations
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Finland
Department of Obstetrics and Gynaecology, University of Oulu
Oulu, Finland, 90014
Sponsors and Collaborators
University of Oulu
Investigators
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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
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Terhi Piltonen/M.D., Ph.D., Dept Ob-Gyn, University of Oulu
ClinicalTrials.gov Identifier: NCT01087879    
Other Study ID Numbers: 191/2006
First Posted: March 16, 2010    Key Record Dates
Last Update Posted: September 7, 2011
Last Verified: September 2011
Keywords provided by University of Oulu:
oral glucose tolerance test
hormonal contraception
androgens
crp
Additional relevant MeSH terms:
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Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Contraceptive Agents
Etonogestrel
Desogestrel
Norelgestromin
Estradiol
Polyestradiol phosphate
Ethinyl Estradiol
Estrogens
 Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Reproductive Control Agents
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Progestins
Contraceptives, Oral, Combined