E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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. |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
Secundary objective: To correlate endo- and exogenous female serum hormone levels with the abovementioned parameters. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | 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.
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
Differences before and after treatment |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 0 |
E.8.5 | The trial involves multiple Member States | No |
E.8.5.1 | Number of sites anticipated in the EEA | 1 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |