BAY88-8223/15396 : Essai de phase 3 randomisé, en double aveugle, évaluant l’efficacité du dichlorure de radium-223 associé à de l’acétate d’abiratérone et de la prednisone ou de la prednisolone, chez des patients ayant un cancer de la prostate résistant à la castration et naïfs de chimiothérapie. [essai clos aux inclusions] L’objectif de cet essai est d’évaluer l’efficacité du dichlorure de radium-223 en association avec de l’acétate d’abiratérone et de la prednisone ou de la prednisolone, chez des patients ayant un canc...

• Pays France
• Organes Prostate
• Spécialités Hormonothérapie, Autres (cryothérapie, radiofréquence, homéopathie,...)

A double-blind, randomized, multi-center study to investigate the endometrial safety of a continuous, combined, oral estrogen/progestin preparation (0.5 mg 17b-estradiol [E2] / 0.25 mg drospirenone [DRSP]) and to compare the bleeding pattern of subjects treated with 0.5 mg E2 / 0.25 mg DRSP with the bleeding pattern of subjects treated with 1.0 mg E2 / 0.5 mg norethisterone acetate (NETA) when used for hormone therapy (HT) for 1 year in post-menopausal women The main objective is to investigate the endometrial safety of a continuous, combined, oral estrogen/progestin preparation.

• Pays Aucun
• Organes Aucun
• Spécialités Aucune

Evaluation of Oral Midazolam in First-trimester Surgical Abortions The purpose of this study is to determine the level of pain, anxiety and side effects that women experience with a surgical abortion and the effect that the anti-anxiety medication, midazo...

• Pays Aucun
• Organes Aucun
• Spécialités Aucune

Randomized, placebo-controlled, double-blind, multi center study to evaluate the safety and efficacy of ciprofloxacin inhale compared to placebo in patients with non-cystic fibrosis bronchiectasis The primary objective of this study in patients with non-CF bronchiectasis with positive sputum culture is to determine the effect of ciprofloxacin inhale on bacterial density, measured by decadic log...

• Pays Aucun
• Organes Aucun
• Spécialités Aucune

Gadobutrol pharmacokinetic and safety study in pediatric subjects aged <2 years (term newborn infants to toddlers 23 months of age inclusive) To evaluate the pharmacokinetics of gadobutrol in plasma at the standard dose of 0.1 mmol/kg body weight in pediatric subjects aged <2 years.

• Pays Aucun
• Organes Aucun
• Spécialités Aucune

A diagnostic interventional, controlled, cross-sectional evaluation of joint status using MRI in subjects with severe hemophilia A treated with primary prophylaxis, secondary prophylaxis, or on-demand therapy To evaluate bone and cartilage damage at different ages using MRI in four index joints of subjects with severe hemophilia A in relation to previous treatment schedule of primary or secondary prophylax...

• Pays Aucun
• Organes Aucun
• Spécialités Aucune

A multicenter, randomized, double-blind, active-controlled, parallel group, 2-arm study to investigate the effect of estradiol valerate/dienogest compared to Microgynon on hormone withdrawal associated symptoms in otherwise healthy women after 6 cycles of treatment "Estudio multicéntrico, aleatorizado, doble ciego, con control activo, con 2 grupos de tratamiento paralelos, para investigar el efecto de estradiol valerato / dienogest comparado con Microgynon, en los síntomas asociados al periodo sin hormona en mujeres sanas, después de 6 ciclos de tratamiento” To show superiority to Microgynon with regard to changes in frequency and intensity of the hormone withdrawal associated symptoms headache and pelvic pain on cycle days 22-28 from baseline to cycle 6 ...

• Pays Aucun
• Organes Aucun
• Spécialités Aucune

Phase I Relative Bioavailability and food effect study The primary objectives of this study are to -investigate the relative bioavailability of a single oral dose of 1.25 mg finerenone ODT and 5 x 0.25 mg ODT (pediatric formulation) in comparison to 10 m...

• Pays Aucun
• Organes Aucun
• Spécialités Aucune

A clinical study to investigate the efficacy and safety of copanlisib in patients with relapsed or refractory diffuse large B-cell lymphoma The primary objective of this study is to assess the potential efficacy (in terms of objective response) of single agent copanlisib in patients with relapsed or refractory DLBCL and assess the relatio...

• Pays Aucun
• Organes Aucun
• Spécialités Aucune

This clinical study evaluates and compares the efficacy and safety of Regorafenib versus placebo in patients with coloreactal cancer after curative resection of liver metastasis and completion of all planned chemotherapy To evaluate and compare the efficacy and safety of regorafenib versus placebo in subjects with colorectal cancer (CRC) after curative resection of liver metastasis and completion of all planned chemot...

• Pays Aucun
• Organes Aucun
• Spécialités Aucune