Polycystic ovary syndrome (PCOS) is the most common hormonal aberration in women of fertile age, with a prevalence of 5-10%, and is associated with chronic anovulation, hyperandrogenism and PCO morphology. Insulin resistance and abdominal obesity are common. The best hormonal treatment for inhibition of excess androgen levels is oral contraceptives (OC) with anti-androgenic properties. A current drug of choice is Yasmin®, which contains etinylestradiol 30µg + drospirenone 3mg per tablet.
Conditions
Interventions
Trade Name: Yasmin
Pharmaceutical Form: Tablet
Sponsors
Karolinska Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Healthy control subjects (no chronic illnesses) - Women who have the PCOS- diagnosis according to Rotterdam criteria - At least 18 but not older than 39 years at the time of the study start - No smoking - BMI > 19 and =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Presence or history of venous or arterial thrombotic/thromboembolic events(e.g. deep venous thrombosis, pulmonary embolism, myocardial infarction) or of a cerebrovascular accident. The presence of a severe or multiple risk factors for venous or arterial thrombosis such as increasing age; smoking (with heavier smoking and increasing age the risk further increases, especially in women over 35 years of age; a positive family history (i.e. venous or arterial trombormbolism ever in sibling or parent at a relative early age); obesity (BMI > 30 kg/m2) dyslipoproteinaemia; hypertension, migraine, valvular heart disease, arterial fibrillation; prolonged immobilization, major surgery and surgery to the legs, or major trauma until two weeks after full remobilization; systemic lupus erythematosus (SLE), Mb Crohn or ulcerative colitis; sickle cell disease. Hereditary or acquired predisposition for APC-resistance, antitrombin-III deficiency, protein-C deficiency, hyperhomocysteinaemia and antiphospholipid antibodies. Pancreatitis or history ofhypertriglyceridaemia. Presence or history of liver tumors (benign or malignant). Known or suspected sex steroid-influenced malignancies (e.g. of the genital organs or the breasts). Contraindication for antimineralocorticoid medication (conditions that predispose to hyperkalemia). History of migraine with focal neurological symptoms. Diabetes mellitus with vascular involvement. Severe dyslipidemia Severe hypertension. Hepatic dysfunction. Adrenal insufficiency. Undiagnosed vaginal bleeding Known or suspected pregnancy. Before spontaneous menstruation has occurred following a delivery or abortion. Breastfeeding or within 2 months after stopping breastfeeding prior to the start of the study medication. An abnormal cervical smear. Use of an injectable hormonal method of contraception; within 6 months of an inj. with a 3-months duration, within 4 months of an inj. with a 2-month duration, within 2 months of an inj. with a 1-months duration.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective: To evaluate the effects of an antiandrogenic oral contraceptive (Yasmin®) on breast cell- turnover mammograhic density, growth factors and hormone receptors in women with polycystic ovary syndrome and healthy control subjects, before and after three months of treatment.;Secondary Objective: Secundary objective: To correlate endo- and exogenous female serum hormone levels with the abovementioned parameters. ;Primary end point(s): Breast cell- turnover mammograhic density, growth factors and hormone receptors in women with polycystic ovary syndrome before and after three months of treatment. Positive impacts from the proposed study: Androgen supplement to HT in menopausal women seem to have positive effects on epithelial cells, cell-proliferation and mammographic density in experimental studies with contradictory results in some epidemiological studies. The effects of androgens have not been not studied in fertile women. We will investigate women with PCOS who have disturbed hormonal balance with excess androgen production This is a study on women with PCOS (n=50) . The PCOS will be diagnosed according to Rotterdam criteria. All participants will be examined before and after three months of treatment with ethinyl estradiol in combination with drosperinone. Fine needle aspiration biopsies and mammograms will be obtained at baseline and after 3 months of treatment. venous blood samples will be drawn and serum levels of male and female sex steroid hormones, stress hormones, growth factors, lipids will be analyzed at baseline and during the last treatment week in the third cycle. | — |
Countries
Sweden
Outcome results
None listed