Breast cell turnover and mammographic density in women with Polycystic Ovary Syndrome (PCOS) - Breast cell turnover PCOS

• Conditions: 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.

• Registration Number: EUCTR2009-010288-17-SE
• Lead Sponsor: Karolinska Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03-13
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: Not specified

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 <30 kg/m2
- Women who are willing to accept OC-treatment
- No contraindications for OC-treatment
- If any kind of hormonal contraception, acceptance for a three months wash-out period before entering the study
- Willing to give informed consent in writing

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified