The Effect of Hormonal Contraceptives on Androgens and Glucose Metabolism

Not Applicable

Completed

• Conditions: Contraception
• Interventions: Drug: Desogestrel-Ethinyl Estradiol contraceptive pill; Drug: Etonogestrel-Ethinyl Estradiol vaginal ring; Drug: Norelgestromin-Ethinyl Estradiol contraceptive patch

• Registration Number: NCT01087879
• Lead Sponsor: University of Oulu

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 Timeline

• Study Start: 2007-10
• Study First Submitted: 2010-03-15
• Study First Submitted QC: 2010-03-15
• Study First Posted: 2010-03-16
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Status Verified: 2011-09
• Last Update Submitted: 2011-09-06
• Last Update Posted: 2011-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 45

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Oral contraceptive pill	Desogestrel-Ethinyl Estradiol contraceptive pill	9 weeks treatment with contraceptive pill.
Contraception vaginal ring	Etonogestrel-Ethinyl Estradiol vaginal ring	9 weeks treatment with vaginal ring.
Transdermal contraceptive patch	Norelgestromin-Ethinyl Estradiol contraceptive patch	9 weeks treatment with a transdermal contraceptive patch.

Primary Outcome Measures

Name	Time	Method
Androgen secretion	0, 5, 9, 10 weeks	Analysis of androstenedione, testosterone and DHEAS from fasting serum samples.
Protein secretion from liver	0, 5, 9, 10 weeks	Analysis of SHBG and high sensitivy CRP from fasting serum samples.

Secondary Outcome Measures

Name	Time	Method
Glucose metabolism	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.

Trial Locations

Locations (1)

Department of Obstetrics and Gynaecology, University of Oulu; 🇫🇮 Oulu, Finland