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A phase III, randomized, controlled, single-blind, multicentre, parallel arm trial to assess the efficacy and safety of Pergoveris® (follitropin alfa and lutropin alfa) and GONAL-f® (follitropin alfa) for multifollicular development as part of an assisted reproductive technology treatment cycle in poor ovarian responders, as defined by the European Society of Human Reproduction and Embryology criteria

The primary objective of the trial is to demonstrate superiority of Pergoveris® versus GONAL-f® in poorovarian response (POR) patients defined according to modified criteria set forth by the European Society of Human Reproduction and Embryology (…

An open-label, multiple-dose, sequential, 2 treatment period study to evaluate the effect of QBW251 on the pharmacokinetics and pharmacodynamics of a monophasic oral contraceptive in pre-menopausal healthy female volunteers

- To assess the effect of QBW251 on the pharmacokinetics of a monophasic combined oral contraceptive containing 30 µg ethinyl estradiol (EE) and 150 µg levonorgestrel (LVG).- To assess the effect of QBW251 on the pharmacodynamics of a monophasic…

Lean Body Mass as a determinant of docetaxel pharmacokinetics and toxicity (LEANDOC)

Primary objective:To determine which anthropometric parameters, LBM, total body weight (TBW) or BSA correlates best to docetaxel exposure (AUC). Secondary objectives:To determine if occurrence of docetaxel toxicity can be related to dose/LBM.To…

GLOBAL STUDY TO ASSESS THE ADDITION OF BEVACIZUMAB TO CARBOPLATIN AND PACLITAXEL AS FRONT-LINE TREATMENT OF EPITHELIAL OVARIAN CANCER, FALLOPIAN TUBE CARCINOMA OR PRIMARY PERITONEAL CARCINOMA

Zie pagina 39-40 van het protocol MO22923 versie 2, 26 Mei 2011

Hysteropexy in treatment of uterine prolapse stage >= 2: laparoscopic sacrohysteropexy versus vaginal sacrospinous hysteropexy (LAVA-trial)

To investigate the hypothesis that women with uterine prolapse stage 2 or more treated by laparoscopic sacrohysteropexy will have equal or lower recurrence rate of prolapse compared to women treated by vaginal sacrospinous hysteropexy.

Immune response after Human Papillomavirus vaccination in patients with automimmune disease

Objective: The primary goal of the current study is to study the immunogenicity and safety of HPV vaccination in patients with an autoimmune disease. Based on retrospective analysis with other vaccines we hypothesize that patients with autoimmune…

Early versus late insemination relative to ovulation in subfertile couples: a trial-based cost-effectiveness study.

The main objective is to determine the effectiveness of IUI-MOS, comparing the ongoing pregnancy rate of a treatment strategy comprising a maximum of four cycles of IUI-MOS when performing IUI 32-36 hours after triggering of ovulation by hCG (*late…

Randomised controlled study comparing AEZS-108 with doxorubicin as second line therapy for locally advanced, recurrent or metastatic endometrial cancer

1. Overall survival (primary efficacy endpoint)2a. Efficacy: progression-free survival (PFS), overall response rate (ORR = CR + PR), and a clincal benefit rate (CBR) will be evaluated as CR + PR + SD for at least 3 months.2b. Safety: adverse events…

Super ovulation in Intra uterine insemination: FSH or Clomifene citrate? The Super Trial.

To determine which ovarian hyperstimulation regimen (FSH or CC) should be applied in IUI in couples with unexplained subfertility or mild male factor subfertility.

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 prospective, multicenter clinical trial to evaluate the safety and the effectiveness of the AEGEA Vapor System* for the treatment of excessive uterine bleeding.

To obtain the safety and effectiveness data necessary to support a Premarket Approval (PMA) Application to the U.S. Food and Drug Administration (FDA)

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.

A Single-Dose, Open-Label, Randomized, 2-Way Crossover Pivotal Study to Assess the Bioequivalence of NGM/EE Tablets Manufactured at 2 Different Facilities

- To establish the bioequivalence of the hormones norgestimate, norelgestromin, and ethinyl estradiol in NGM/EE Schaffhausen tablets compared with the same hormones in NGM/EE Manati tablets.- To assess the safety and tolerability of both…

Pelvic organ mobility after treatment for uterine descent

The primary objective is to assess the differences in mobility of pelvic organs between three commonly performed treatment options for uterine descent (vaginal hysterectomy, vaginal sacrospinous hysteropexy and laparoscopic sacrohysteropexy). The…

Urodynamic effect of Prostate Artery Embolization for lower urinary tract symptoms due to benign prostate hyperplasia

Primary Objective: - To determine the urodynamic effects of PAE on bladder outlet resistance (BOR), Qmax, bladder contractility, and post-void residual (PVR).Secondary Objective(s): - IPSS/QoL scores.- Prostate Volume.- Prostate Specific Antigen…

Hyperthermia induced homologous recombination (HR) deficiency in cervical carcinoma

To investigate whether hyperthermia induces HR-deficiency in cervical tumors and as a feasibility study, secondly to investigate whether it is possible to detect circulating tumor cells before and after hyperthermia.

A Post-Market Clinical Follow-up Study to Investigate the Usability of the CollaGUARD Adhesion Barrier following Hysteroscopic Adhesiolysis

This study is designed to determine the usability of the CollaGUARD adhesion barrier in gynecological surgery. The aim is to collect qualitative and quantitative data in a small number of subjects (pilot study) to gain information on the usability…

TREATMENT ALTERNATIVES FOR SUBFERTILE WOMEN WITH CLASS II ANOVULATION NOT CONCEIVING AFTER SIX OVULATORY CYCLES WITH CLOMIPHENE CITRATE

The purpose of this study is to assess the effectiveness of extended treatment with CC compared to treatment with gonadotropins and/or the use of intra-uterine insemination (IUI), in patients who had six ovulatory cycles after CC, but did not…

Sacrospinous ligament fixation combined with anterior colporrhaphy versus Elevate Anterior procedure in treatment of primary apical and anterior compartment prolapse stage >= 2: a multi-center randomised controlled trial.

To compare the effects of sacrospinous ligament fixation combined with anterior colporrhaphy versus Elevate Anterior procedure on pelvic floor function.

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…