The Impact of Different Administration Routes of Hormonal Contraceptives on Androgen Synthesis, Glucose Metabolism and Inflammation. A Prospective Randomized Trial.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Oulu
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Androgen secretion
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 35 Years (Adult)
- Sex
- Female
- Accepts 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
- •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
Arms & Interventions
Oral contraceptive pill
9 weeks treatment with contraceptive pill.
Intervention: Desogestrel-Ethinyl Estradiol contraceptive pill (Drug)
Contraception vaginal ring
9 weeks treatment with vaginal ring.
Intervention: Etonogestrel-Ethinyl Estradiol vaginal ring (Drug)
Transdermal contraceptive patch
9 weeks treatment with a transdermal contraceptive patch.
Intervention: Norelgestromin-Ethinyl Estradiol contraceptive patch (Drug)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Glucose metabolism(0, (5), 9, (10) weeks)