The Effect of Hormonal Contraceptives on Androgens and Glucose Metabolism

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Contraception

Intervention / Treatment
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* Drug: Desogestrel-Ethinyl Estradiol contraceptive pill
* Drug: Etonogestrel-Ethinyl Estradiol vaginal ring
* Drug: Norelgestromin-Ethinyl Estradiol contraceptive patch


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Oral contraceptive pill<br>9 weeks treatment with contraceptive pill. | Drug: Desogestrel-Ethinyl Estradiol contraceptive pill<br>* 150 microg Desogestrel and 20 microg Ethinyl Estradiol combination. One pill once a day for 9 weeks, continual administration.<br>* Other names: Mercilon;|
| Active Comparator: Contraception vaginal ring<br>9 weeks treatment with vaginal ring. | Drug: Etonogestrel-Ethinyl Estradiol vaginal ring<br>* 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.<br>* Other names: NuvaRing;|
| Active Comparator: Transdermal contraceptive patch<br>9 weeks treatment with a transdermal contraceptive patch. | Drug: Norelgestromin-Ethinyl Estradiol contraceptive patch<br>* 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.<br>* Other names: Evra;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Androgen secretion | Analysis of androstenedione, testosterone and DHEAS from fasting serum samples. | 0, 5, 9, 10 weeks | 
| Protein secretion from liver | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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crp, oral glucose tolerance test, hormonal contraception, androgens