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Reducing Gas Embolisation During Hysteroscopic Surgery by limiting the amount of intravasation with the installation of intracervical terlipressin (HYSTER)

Objective: The primary objective of the study is to determine whether the intracervical installation of vasopressin reduces the incidence and severity of gas embolism as detected by trans oesophageal echocardiography (TOE…

A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study of Tasquinimod in Men with Metastatic Castrate-Resistant Prostate Cancer.

The primary objective of this study is:To confirm the effect of Tasquinimod on delaying disease progression or death compared with placebo.The secondary objectives of this study are:• To determine the effect of Tasquinimod on overall survival, time…

A Phase 3 Randomized, Double-blind, Placebo-controlled, Multicenter Study of AMG 386 With Paclitaxel and Carboplatin as First-line Treatment of Subjects With FIGO Stage III-IV Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancers

To estimate the treatment effect and safety of AMG 386 in combination with paclitaxel + carboplatin in subjects with FIGO Stage III-IV Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancers.

Two-Center, In-Patient, Randomized, Placebo and Active Comparator Evaluation of the Pharmacokinetics (PK) and Safety, Along with Initial Pharmacodynamic (PD) Efficacy of Three Dose Levels of TBS-2 Intranasal Gel Applied Twice-Daily (BID) for up to Three Days in Female Patients with Hypoactive Sexual Desire Disorder (HSDD) or Anorgasmia (ANOR).

This clinical trial is being performed to evaluate the PK profile of TBS-2 administered as single and multiple (BID) doses in patients with HSDD or ANOR. In addition, the study will evaluate the initial PD efficacy and safety of intranasal TBS-2 BID…

A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of MORAb-003 (farletuzumab) in Combination with Paclitaxel Therapy in Subjects with Platinum-Resistant or Refractory Relapsed Ovarian Cancer

To compare the effect of paclitaxel plus MORAb-003 to paclitaxel plus placebo on progression free survival (PFS) as determined by RECIST in subjects who are in a first platinum-resistant or refractory relapse of ovarian cancer.

The influence of supplementary regional infiltration anesthesia with ropivacaine on postoperative pain, nausea and vomiting in patients undergoing mamma surgery under general anesthesia

To investigate that in mamma surgery, regional infiltration with ropivacaine 0,75% added to general anaesthesia causes less postoperative pain, nausea and vomiting compared to general anaesthesia alone.

A Phase II Study to Evaluate: Delay in Intravaginal Ejaculatory Latency Time (IELT), Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Two Oral Doses of GSK557296 in a Randomized, Double Blind, Placebo-Controlled, Parallel Group Study in Men with Premature Ejaculation

To determine if an on demand dosing of 50 or 150 mg of GSK557296 demonstratessuperior efficacy with respect to duration of IELT during an 8 week study periodcompared to placebo in men with premature ejaculation.To assess safety and tolerability of…

A phase I, mono-center, placebo and comparator controlled, single-blind, randomized, parallel group, clinical study to determine multiple dose safety, tolerability, pharmacokinetics, and pharmacodynamics of FSH-GEX* administered subcutaneously in healthy pituitary-suppressed female volunteers

- To assess the safety and tolerability of FSH-GEX* following multiple dose administration by subcutaneous injection- To determine the pharmacokinetic profile of FSH-GEX* following multiple dose administration by subcutaneous injection- To assess…

A prospective, randomized, double-blind, double-dummy, placebo- and active controlled, multicenter study assessing the efficacy and safety of the combination BAY 60 4552 / vardenafil compared to vardenafil (20 mg) for the treatment of erectile dysfunction not sufficiently responsive to standard therapy with PDE5 inhibitors

The primary objective of the study is to demonstrate the superiority of the combination BAY 60 4552 / vardenafil over vardenafil alone in the treatment of erectile dysfunction not sufficiently responsive to standard therapy with PDE5 inhibitors.The…

Phase 1b/2 Study to Assess the Safety and Efficacy of AMG 102 in Combination
with Mitoxantrone and Prednisone in Subjects with Previously Treated Castrate Resistant Prostate Cancer

The objective of the study (phase 2) is to evaluate the effectiveness of AMG 102 in combination with Mitoxantrone and Prednisone in previously treated subjects with castrate resistant prostate cancer.

A Combined Escalating Single Oral Dose and Multiple Oral Dose Trial investigating Safety, Tolerance, Pharmacokinetics and Pharmacodynamics of SCH 900479 in Healthy Postmenopausal Female Subjects

Primary:To investigate the safety and tolerability of single oral administration of study medication in healthy postmenopausal females (Part I)To investigate the general safety and tolerability of the study medication in healthy postmenopausal…

A Phase 3, Randomized, Double-Blind, Multicenter Trial Comparing Orteronel (TAK 700) Plus Prednisone With Placebo Plus Prednisone in Patients With Metastatic Castration-Resistant Prostate Cancer That Has Progressed During or Following Docetaxel-based Therapy

Primary Objective:• To determine if orteronel plus prednisone improves overall survival (OS)Key Secondary Objectives: • To determine if orteronel plus prednisone improves radiographic progression-free survival (rPFS)• To determine if orteronel plus…

Randomized, Double-Blind, Phase 3 Trial to Compare the Efficacy of Ipilimumab vs
Placebo in Asymptomatic or Minimally Symptomatic Patients with Metastatic
Chemotherapy-Naïve Castration Resistant Prostate Cancer

The objective of this study is to compare the overall survival of patients with prostate cancer who are no longer responding to hormone therapy (castration resistant) and who have not yet received chemotherapy live longer (overall survival) when…

A Study in Japan and Ex-Japan to Characterize the Pharmacokinetic and Pharmacodynamic Response to Orteronel (TAK-700) in Chemotherapy-Naïve Patients With Castration-Resistant Prostate Cancer

Primary objective:* To determine whether orteronel 300 mg twice daily (BID) plus prednisone 5 mg BID more effectively reduces serum testosterone levels, compared to placebo plus prednisone 5 mg BID, when administered to patients in JapanSecondary…

PK/PD trial with different dose regimens of Cyclogest® in comparison to Crinone® and placebo in healthy female subjects

To investigate the effect of various dose regimens of Cyclogest® on secretory transformation of the endometrium in comparison to Crinone® and placeboTo investigate single and multiple dose pharmacokinetics of Cyclogest®To investigate safety and…

A phase I, mono-center, randomized, placebo and comparator controlled, single blind, rising dose, clinical study to determine single dose pharmacokinetics, pharmacodynamics, safety and tolerability of four doses of FSH-GEX* according to adaptive design (25, 75, 150 and 300 IU) administered subcutaneously in healthy pituitary-suppressed female volunteers

- To assess the safety and (local) tolerability of test compound following single rising dose administration by subcutaneous injection- To determine FSH pharmacokinetic parameters including Cmax and AUC0-last of test compound following single rising…

Selenium and Prostate Cancer; Clinical Trial on Availability to Prostate Tissue and Effects on Gene Expression.

The aim of this study is to get insight into bioavailability of selenium in prostate tissue and changes of gene expression profiles that might be responsible for selenium-induced chemoprevention. To meet this objective, the relationship between…

The long-term immune response after HPV16 peptide vaccination in woman with low-grade pre-malignant disorders of the uterine cervix, a placebo controlled phase II study

Evaluation of the capacity of a HPV 16 peptide vaccine to install a long term HPV-specific T cell response, to define the importance of a booster vaccine after 1 year, the induction of Cytotoxic T lymphocyte (CTL) immunity against HPV16E6 and E7 and…

The effect of HPV16 peptide vaccination on the local immune response in woman with high grade HPV16+ pre-malignant disorders of the uterine cervix, a placebo controlled phase II study

This study aims to reveal whether vaccination of women with HPV 16+ cervical intraepithelial neoplasia not only results in a strong systemic T-cell response, but also endows these T-cells with the capacity to infiltrate HPV16-induced lesions.…

A randomized, double blind, parallel group study of vardenafil flexible dose versus placebo in males with erectile dysfunction and their female partners* sexual quality of life. PARTNER II.

1. Success of maintenance of erection in men with ED.and 2. Improvement of their female partner*s sexual quality of life.