Randomized phase II study to investigate the efficacy, safety and tolerability of ZK 230211 (25 mg vs. 100 mg) as second-line endocrine therapy for postmenopausal women with hormone receptor-positive metastatic breast cancer To evaluate efficacy (clinical benefit) of two doses of ZK PRA (25 mg and 100 mg) when administered once daily p.o.

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A double-blind, randomized, uncontrolled study to evaluate inhibition of ovulation of two oral estradiol / drospirenone regimens in healthy young female volunteers over a period of 3 treatment cycles The primary objective of the study is to evaluate the inhibition of ovulation in treatment cycles 2 and 3 after administration of two different (one mono- and one triphasic) 24-day regimens containing...

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A multi-center, double-blind, randomized, parallel-group study to evaluate cycle control and safety of 6 different regimens of an oral contraceptive containing estradiol and drospirenone in healthy female volunteers aged between 18 and 35 years over 7 cycles The primary objective of this study is to evaluate and compare the cycle control and bleeding patterns of six different regimens of the combination estradiol and drospirenone over 7 cycles of treatmen...

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A multi-center, open-label, randomized, controlled, parallel-group study to assess efficacy and safety of an extended flexible regimen of the combined oral contraceptive SH T00186D (0.02 mg ethinylestradiol as beta-cyclodextrin clathrate and 3 mg drospirenone) compared to the conventional regimen of SH T00186D in the treatment of primary dysmenorrhea To evaluate efficacy and safety of the combined oral contraceptive [COC] SH T00186D (0.02 mg ethinylestradiol [EE]; 3 mg drospirenone [DRSP]) applied in a conventional and an extended flexible regimen...

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An open-label, non-randomized, multi-center study to optimize image assessment and evaluate the efficacy and safety of BAY 94-9172 (ZK 6013443) positron emission tomography (PET) for detection/exclusion of cerebral beta-amyloid in patients with probable Alzheimer’s disease compared to healthy volunteers To determine the sensitivity and specificity of the independent visual assessment of BAY 94-9172 PET images (from the 90 to 110 min imaging window) in detecting/excluding cerebral amyloid beta in pati...

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Multi-center, randomized comparison study to eVALUatE outcomes and resource needs of imaging and treatment following Primovist-enhanced MRI of the liver in comparison to extracellular contrast media (ECCM)-enhanced MRI and contrast-enhanced computed tomography (CT) in patients with a history of colorectal cancer and known or suspected metachronous liver metastases The main objective of this study is to evaluate outcomes and resource needs of imaging and treatment following Primovist-enhanced MRI (PV-MRI) as compared to ECCM-enhanced MRI (ECCM-MRI) and contrast-...

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Phase I/II study to investigate the safety, tolerability, efficacy and pharmacokinetics of ZK 219477 in combination with cisplatin as first-line therapy in chemotherapy-naive patients with extensive-disease (ED) stage small-cell lung cancer (SCLC) Phase I-part: To determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of ZK 219477 in combination with cisplatin To investigate the safety and tolerability of ZK 219477 in co...

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Myocardial perfusion with an intravascular contrast agent Not provided at time of registration

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Multi-center, open, randomized, dose finding phase II study to investigate for a maximum of three years ultra low dose levonorgestrel contraceptive intrauterine systems (LCS) releasing in vitro 12 µg/24 h and 16 µg/24 h of levonorgestrel compared to MIRENA in nulliparous and parous women in need of contraception The objective of this study is to search for an appropriate levonorgestrel dose for a new contraceptive intrauterine system (IUS) suitable for use by non-parous and parous women.

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A multicenter, open, randomized, parallel-group comparison to assess the safety and efficacy of the oral contraceptive SH T 00186 D (0.02 mg ethinylestradiol as betadex clathrate and 3 mg drospirenone) in two variations of an extended regimen vs. a standard regimen (24 + 4 days) in 1122 healthy female volunteers for one year, followed by a 1-year safety extension To evaluate the safety and efficacy of 2 variations of an extended regimen of the oral contraceptive SH T 00186 D (0.02 mg EE as ß-CDC and 3 mg DRSP) compared to the standard 24 + 4-day regimen of th...

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