The Effect of Hormonal Contraceptives on Androgens and Glucose Metabolism

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01087879

Enrollment

Registered

2010-03-16

Start date

2007-10-31

Completion date

2011-01-31

Last updated

2011-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Contraception

Keywords

oral glucose tolerance test, hormonal contraception, androgens, crp

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.

Interventions

DRUGDesogestrel-Ethinyl Estradiol contraceptive pill

150 microg Desogestrel and 20 microg Ethinyl Estradiol combination. One pill once a day for 9 weeks, continual administration.

DRUGEtonogestrel-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.

DRUGNorelgestromin-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.

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 35 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026