Lipid Regulating Agents

All Drugs and Chemicals

Reproductive Control Agents

Antineoplastic Agents

Bone Density Conservation Agents

Rosuvastatin Calcium

Ethinyl Estradiol

Levonorgestrel

Contraceptive Agents

Poly(ADP-ribose) Polymerase Inhibitors

Contraceptives, Oral

Contraceptives, Oral, Combined

Rucaparib

Calcium

Calcium, Dietary

Anticholesteremic Agents

Hypolipidemic Agents

Antimetabolites

Hydroxymethylglutaryl-CoA Reductase Inhibitors

Enzyme Inhibitors

Contraceptive Agents, Female

Rucaparib 600 mg BID commencing on Day 5 until Day 23.

Single dose of 20mg oral rosuvastatin on Day 1 and Day 19 only.

Rosuvastatin

Single dose of combined oral contraceptive (30 μg ethinylestradiol and 150 μg levonorgestrel) on Day 1 and Day 19 only.

Oral Contraceptives

This study will investigate the drug-drug interactions (DDIs) between rucaparib and oral rosuvastatin (Arm A), and between rucaparib and oral ethinylestradiol and levonorgestrel (Arm B), with rucaparib as a perpetrator.

This is a Phase 1, open-label, drug-drug-interaction (DDI) study in patients with advanced solid tumor. In Part I, the effects of rucaparib (600 mg twice daily \[BID\]) on the PK of oral rosuvastatin (Arm A) and the combined oral contraceptives (ethinylestradiol and levonorgestrel; Arm B) will be assessed.

Part I: patients will receive single oral doses of rosuvastatin or oral contraceptives (according to assigned arm) on Day 1 and Day 19. Continuous treatment with rucaparib at 600 mg BID will commence on Day 5 and continue until the end of Part I (Day 23).

Part II (optional): treatment with rucaparib in 28-day cycles may continue (at the discretion of the Investigator) until progression of disease, unacceptable toxicity, or other reason for discontinuation.

Both male and female patients are eligible for Arm A. Female patients only are eligible for Arm B.

Drug-Drug Interaction Study of Rucaparib, Rosuvastatin and Oral Contraceptives

A Phase 1, Open-label, Drug-drug-interaction Study to Determine the Effect of Rucaparib on the Pharmacokinetics of Oral Rosuvastatin (Arm A) and Oral Contraceptives (Ethinylestradiol and Levonorgestrel) (Arm B) in Patients With Advanced Solid Tumors

Area under the concentration-time curve (AUC) from time zero up to the last time point with a quantifiable concentration (AUC0-last)

AUC up to time infinity, with extrapolation of the terminal phase (AUC0-inf)

Apparent total clearance of drug after oral administration (CL/F)

Apparent volume of distribution during terminal phase (Vz/F)

pharmaand GmbH

Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Syndrome

Polycystic Ovary Syndrome

Cysts

Ovarian Cysts

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Gonadal Disorders

Endocrine System Diseases

Natriuretic Agents

Micronutrients

Drospirenone

Vitamins

Drospirenone and ethinyl estradiol combination

Estradiol 17 beta-cypionate

Estradiol 3-benzoate

Estradiol

Polyestradiol phosphate

Mineralocorticoid Receptor Antagonists

Mineralocorticoids

Hormones

Hormone Antagonists

Diuretics

Diuretics, Potassium Sparing

Contraceptives, Oral, Hormonal

Contraceptive Agents, Hormonal

Estrogens

45 minutes each day for three times/week for 6 months

Physical exercise

1 cp for 21 days each month for 6 months of OC (Drospirenone 3 mg plus Ethynylestradiol 30 microgram = Yasmin, Schering, Milan, Italy)

OC - Drospirenone plus Ethynylestradiol

Tablet of vitamin 1cp for 21 days each month for 6 months

Vitamin, polyvitamins tablets

Francesco Orio, MD,PhD

Gaetano Lombardi, MD

Stefano Palomba, MD

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

Oral Contraceptive and Cardiovascular Risk in PCOS

Comparison of Oral Contraceptive Versus Physical Exercise Effects on Cardiovascular and Metabolic Risk Factors in PCOS Women

Federico II University

Francesco Orio

Diseases and Abnormalities at or Before Birth

Skin and Connective Tissue Diseases

Nutritional and Metabolic Diseases

Rare Diseases

Inflammation

Hyperandrogenism

Hirsutism

Disorders of Sex Development

46, XX Disorders of Sex Development

Congenital Abnormalities

Urogenital Abnormalities

Adrenal Hyperplasia, Congenital

Adrenogenital Syndrome

Male Urogenital Diseases

Chronic Graft Versus Host Disease

Congenital Adrenal Hyperplasia

21-hydroxylase Deficiency

Hypoglycemic Agents

Metformin

Cyproterone Acetate

Cyproterone

Androgens

Androgen Antagonists

Contraceptive Agents, Male

Ethynyl-estradiol plus cyproterone acetate

Héctor F Escobar-Morreale, MD, PhD

Cardiovascular risk factors cluster in hyperandrogenic women - including those presenting with the polycystic ovary syndrome - in association with insulin resistance, obesity, and other metabolic disorders.

The present clinical trial intends to compare the effects of oral contraceptives and metformin on PCOS patients, focusing on classic and non-classic cardiovascular risk markers and indexes of cardiovascular performance, in order to whether or not, as suspected by previous data obtained in non-hyperandrogenic women, oral contraceptives worsen the cardiovascular risk profile of PCOS women, favoring the use of metformin if the latter actually ameliorates such a risk.

Effects of Metformin vs Oral Contraceptives on CV Risk Markers in PCOS

The Cardiovascular Risk Profile Associated With The Polycystic Ovary Syndrome And With Ovulatory Hyperandrogenism, And Its Changes During Treatment With Metformin Or Oral Contraceptives

Hospital Universitario Ramon y Cajal

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Drug-Drug Interaction Study of Rucaparib, Rosuvastatin and Oral Contraceptives	NCT03954366	Neoplasms	Rucaparib Rosuvastatin Oral Contracept...	18 Years -	pharmaand GmbH
Oral Contraceptive and Cardiovascular Risk in PCOS	NCT00593294	Polycystic Ovar...	Physical exerci... OC - Drospireno... Vitamin, polyvi...	18 Years - 40 Years	Federico II University
Drug-Drug Interaction Study of Rucaparib, Rosuvastatin and Oral Contraceptives	NCT03954366	Neoplasms	Rucaparib Rosuvastatin Oral Contracept...	18 Years -	pharmaand GmbH
Effects of Metformin vs Oral Contraceptives on CV Risk Markers in PCOS	NCT00428311	Polycystic Ovar...	Metformin Ethynyl-estradi...	12 Years - 45 Years	Hospital Universitario Ramon y Cajal

Spots Global Cancer Trial Database for oral contraceptives