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

History of Changes

Tracking Information

First Received Date ^ICMJE

March 15, 2010

Last Updated Date

September 6, 2011

Start Date ^ICMJE

October 2007

Primary Completion Date

January 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01087879 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

The Effect of Hormonal Contraceptives on Androgens and Glucose Metabolism

Official Title ^ICMJE

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

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.

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 ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Contraception

Intervention ^ICMJE

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
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
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

Study Arm (s)

Active Comparator: Oral contraceptive pill
9 weeks treatment with contraceptive pill.

Intervention: Drug: Desogestrel-Ethinyl Estradiol contraceptive pill
Active Comparator: Contraception vaginal ring
9 weeks treatment with vaginal ring.

Intervention: Drug: Etonogestrel-Ethinyl Estradiol vaginal ring
Active Comparator: Transdermal contraceptive patch
9 weeks treatment with a transdermal contraceptive patch.

Intervention: Drug: Norelgestromin-Ethinyl Estradiol contraceptive patch

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

January 2011

Primary Completion Date

January 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

20 Years to 35 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Finland

Administrative Information

NCT Number ^ICMJE

NCT01087879

Other Study ID Numbers ^ICMJE

191/2006

Has Data Monitoring Committee

Responsible Party

Terhi Piltonen/M.D., Ph.D., Dept Ob-Gyn, University of Oulu

Study Sponsor ^ICMJE

University of Oulu

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

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

Information Provided By

University of Oulu

Verification Date

September 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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