DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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 secretion

Protein 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

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017