The Effect of Hormonal Contraceptives on Androgens and Glucose Metabolism
|ClinicalTrials.gov Identifier: NCT01087879|
Recruitment Status : Completed
First Posted : March 16, 2010
Last Update Posted : September 7, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Contraception||Drug: Desogestrel-Ethinyl Estradiol contraceptive pill Drug: Etonogestrel-Ethinyl Estradiol vaginal ring Drug: Norelgestromin-Ethinyl Estradiol contraceptive patch||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||45 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Impact of Different Administration Routes of Hormonal Contraceptives on Androgen Synthesis, Glucose Metabolism and Inflammation. A Prospective Randomized Trial.|
|Study Start Date :||October 2007|
|Actual Primary Completion Date :||January 2011|
|Actual Study Completion Date :||January 2011|
Active Comparator: Oral contraceptive pill
9 weeks treatment with contraceptive pill.
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
Active Comparator: Contraception vaginal ring
9 weeks treatment with vaginal ring.
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
Active Comparator: Transdermal contraceptive patch
9 weeks treatment with a transdermal contraceptive patch.
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
- Androgen secretion [ Time Frame: 0, 5, 9, 10 weeks ]Analysis of androstenedione, testosterone and DHEAS from fasting serum samples.
- Protein secretion from liver [ Time Frame: 0, 5, 9, 10 weeks ]Analysis of SHBG and high sensitivy CRP from fasting serum samples.
- Glucose metabolism [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01087879
|Department of Obstetrics and Gynaecology, University of Oulu|
|Oulu, Finland, 90014|
|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|