Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| CE209/07 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Oral contraceptive therapy is routinely used for the treatment of menstrual disturbances of patients with polycystic ovary syndrome (PCOS).
To date, the cardiovascular risk (CVR) of the oral contraceptives (OC) are known but no data are available on the CVR in PCOS patients treated with OC or physical exercise.
The purpose of this study is to compare the effects of OC to physical exercise on the CVR of PCOS women and show the hormonal and metabolic effects of these two different treatment.
We hypothesize that physical exercise has the same beneficial effects of OC therapy on hormonal and metabolic features of PCOS women with less cardiovascular consequences.
One hundred and fifty PCOS women will be enrolled. The diagnosis of PCOS was made based according to the Rotterdam criteria (1). Specifically, patients with anovulation and clinical and/or biochemical hyperandrogenism were enrolled.
Patients will be randomly allocated in three groups (OC, physical exercise and placebo group) using a computer-software. Fifty PCOS patients will be treated with OC (Drospirenone 3 mg, Ethynylestradiol 30 microgram = Yasmin, Schering, Milan,Italy) other fifty PCOS will be undergone physical exercise, whereas other fifty will be treated with placebo tablets (one tablet once daily; placebo group). The duration of the treatment will be 6 months.
Patients treated with OC will be instructed to follow their usual diet and physical activity, whereas patients undergone to physical exercise will be instructed to follow a detailed regular physical training program and for the diet they will be advised for the quality of food to eat. All subjects will be nonsmokers and none will drink alcoholic beverages.
Each subject will undergo follow-up visits under (at three and 6 months from treatment starting) and after treatment (at three and 6 months from treatment withdrawal). At each follow-up visit, in all subjects the same operator will perform clinical, hormonal, metabolic and cardiovascular assessments by carotid and brachial artery US
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A,1,I | Experimental |
| |
| B, 2, II | Active Comparator |
| |
| C,3,III | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physical exercise | Behavioral | 45 minutes each day for three times/week for 6 months |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Outcomes: Intima media thickness by carotid ultrasonography (US) and Flow Mediated Dilation by brachial artery US | Basal and after 3 and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Outcomes: Clinical, hormonal, and metabolic assessments | Basal and after 3 and 6 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Francesco Orio, MD,PhD | Department of Molecular and Clinical Endocrinology and Oncology University Federico II Naples Italy | Principal Investigator |
| Gaetano Lombardi, MD | Department of Molecular and Clinical Endocrinology and Oncology University Federico II Naples Italy | Study Director |
| Stefano Palomba, MD | Chair of Obstetrics and Gynecology, University "Magna Graecia" Catanzaro, Italy | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Molecular and Clinical Endocrinology and Oncology, University "Federico II" | Naples | Naples | 80131 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14711538 | Background | Rotterdam ESHRE/ASRM-Sponsored PCOS Consensus Workshop Group. Revised 2003 consensus on diagnostic criteria and long-term health risks related to polycystic ovary syndrome. Fertil Steril. 2004 Jan;81(1):19-25. doi: 10.1016/j.fertnstert.2003.10.004. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 |
Not provided
Not provided
| ID | Term |
|---|---|
| D015444 | Exercise |
| D004997 | Ethinyl Estradiol |
| D014815 | Vitamins |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| OC - Drospirenone plus Ethynylestradiol |
| Drug |
1 cp for 21 days each month for 6 months of OC (Drospirenone 3 mg plus Ethynylestradiol 30 microgram = Yasmin, Schering, Milan, Italy) |
|
| Vitamin, polyvitamins tablets | Dietary Supplement | Tablet of vitamin 1cp for 21 days each month for 6 months |
|
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D001519 | Behavior |
| D009651 | Norpregnatrienes |
| D009650 | Norpregnanes |
| D009654 | Norsteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D042782 | Estrogenic Steroids, Alkylated |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D018977 | Micronutrients |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000078622 | Nutrients |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |