EUCTR2009-010288-17-SEActive, not recruitingNot Applicable
Breast cell turnover and mammographic density in women with Polycystic Ovary Syndrome (PCOS) - Breast cell turnover PCOS
Karolinska Hospital0 sitesStarted: March 13, 2009Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- Female
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.
Investigators
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