The Effect of Hormonal Contraceptives on Androgens and Glucose Metabolism

Contraception Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01087879
• Other study ID #: 191/2006
• Status: Completed
• Phase: N/A
• First received: March 15, 2010
• Last updated: September 6, 2011
• Start date: October 2007
• Est. completion date: January 2011

Study information

• Verified date: September 2011
• Source: University of Oulu
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 35 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Contraception

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Finland	Department of Obstetrics and Gynaecology, University of Oulu	Oulu

Sponsors (1)

Lead Sponsor	Collaborator
University of Oulu

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Androgen secretion	Analysis of androstenedione, testosterone and DHEAS from fasting serum samples.	0, 5, 9, 10 weeks	No
Primary	Protein secretion from liver	Analysis of SHBG and high sensitivy CRP from fasting serum samples.	0, 5, 9, 10 weeks	No
Secondary	Glucose metabolism	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	No