The Effect of Hormonal Contraceptives on Androgens and Glucose Metabolism

University of Oulu

Status: Completed

Conditions: Contraception

Treatments: Drug: Norelgestromin-Ethinyl Estradiol contraceptive patch; Drug: Etonogestrel-Ethinyl Estradiol vaginal ring; Drug: Desogestrel-Ethinyl Estradiol contraceptive pill

Study type: Interventional

Funder types: Other

Identifiers

NCT01087879

191/2006

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 estimated patients

Sex: Female

Ages: 20 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 3 patient groups

Oral contraceptive pill

Active Comparator group

Description:

9 weeks treatment with contraceptive pill.

Treatment:

Drug: Desogestrel-Ethinyl Estradiol contraceptive pill

Contraception vaginal ring

Active Comparator group

Description:

9 weeks treatment with vaginal ring.

Treatment:

Drug: Etonogestrel-Ethinyl Estradiol vaginal ring

Transdermal contraceptive patch

Active Comparator group

Description:

9 weeks treatment with a transdermal contraceptive patch.

Treatment:

Drug: Norelgestromin-Ethinyl Estradiol contraceptive patch