The Effect of Hormonal Contraceptives on Androgens and Glucose Metabolism

September 6, 2011 updated by: University of Oulu

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Oulu, Finland, 90014
        • Department of Obstetrics and Gynaecology, University of Oulu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • 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 Names:
  • Evra

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Androgen secretion
Time Frame: 0, 5, 9, 10 weeks
Analysis of androstenedione, testosterone and DHEAS from fasting serum samples.
0, 5, 9, 10 weeks
Protein secretion from liver
Time Frame: 0, 5, 9, 10 weeks
Analysis of SHBG and high sensitivy CRP from fasting serum samples.
0, 5, 9, 10 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
0, (5), 9, (10) weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

March 15, 2010

First Submitted That Met QC Criteria

March 15, 2010

First Posted (Estimate)

March 16, 2010

Study Record Updates

Last Update Posted (Estimate)

September 7, 2011

Last Update Submitted That Met QC Criteria

September 6, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 191/2006

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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