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The Effect of Hormonal Contraceptives on Androgens and Glucose Metabolism

This study has been completed.
Sponsor:
Information provided by:
University of Oulu
ClinicalTrials.gov Identifier:
NCT01087879
First received: March 15, 2010
Last updated: September 6, 2011
Last verified: September 2011
  Purpose

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
Contraception
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 ] [ Designated as safety issue: No ]
    Analysis of androstenedione, testosterone and DHEAS from fasting serum samples.

  • Protein secretion from liver [ Time Frame: 0, 5, 9, 10 weeks ] [ Designated as safety issue: No ]
    Analysis of SHBG and high sensitivy CRP from fasting serum samples.


Secondary Outcome Measures:
  • Glucose metabolism [ Time Frame: 0, (5), 9, (10) weeks ] [ Designated as safety issue: No ]
    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.

  Eligibility

Ages Eligible for Study:   20 Years to 35 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01087879

Locations
Finland
Department of Obstetrics and Gynaecology, University of Oulu
Oulu, Finland, 90014
Sponsors and Collaborators
University of Oulu
Investigators
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

No publications provided by University of Oulu

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

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

Additional relevant MeSH terms:
3-keto-desogestrel
Androgens
Contraceptive Agents
Desogestrel
Estradiol
Estradiol 17 beta-cypionate
Estradiol 3-benzoate
Estradiol valerate
Ethinyl Estradiol
Norelgestromin
Polyestradiol phosphate
Contraceptive Agents, Female
Contraceptives, Oral
Contraceptives, Oral, Combined
Contraceptives, Oral, Synthetic
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Progestins
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 23, 2014