The Effect of Hormonal Contraceptives on Androgens and Glucose Metabolism
Information source: University of Oulu
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Contraception
Intervention: Desogestrel-Ethinyl Estradiol contraceptive pill (Drug); Etonogestrel-Ethinyl Estradiol vaginal ring (Drug); Norelgestromin-Ethinyl Estradiol contraceptive patch (Drug)
Phase: N/A
Status: Completed
Sponsored by: University of Oulu Official(s) and/or principal investigator(s): Juha S. Tapanainen, Professor, Study Chair, Affiliation: Dept Ob-Gyn, University of Oulu Terhi T. Piltonen, MD, Study Director, Affiliation: Dept Ob-Gyn, University of Oulu Johanna M. Puurunen, MD, Principal Investigator, Affiliation: Dept Ob-Gyn, Univeristy of Oulu
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.
Clinical Details
Official title: The Impact of Different Administration Routes of Hormonal Contraceptives on Androgen Synthesis, Glucose Metabolism and Inflammation. A Prospective Randomized Trial.
Study design: Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Androgen secretionProtein secretion from liver
Secondary outcome: Glucose metabolism
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.
Eligibility
Minimum age: 20 Years.
Maximum age: 35 Years.
Gender(s): Female.
Criteria:
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
Locations and Contacts
Department of Obstetrics and Gynaecology, University of Oulu, Oulu 90014, Finland
Additional Information
Starting date: October 2007
Last updated: September 6, 2011
|