23 results
To compare the pharmacokinetics of sublingual testosterone cyclodextrin followed by buspirone as an encapsulated tablet with administration of testosterone and buspirone as one tablet designed to release the components in a specific time-frame.
Primary objectives:To establish the lowest effective dose using physiological and subjective measures of sexual arousal.To evaluate and compare the pharmacokinetics of testosterone and its metabolites following administration of three (3) doses (0.…
Primary ObjectiveTo investigate the possible efficacy of combined administration of 0.5 mg sublingual testosterone and 10 mg tadalafil in increasing sexual satisfaction during sexual activity in the domestic setting in healthy female subjects with…
Primary objective:To compare the pharmacokinetics of testosterone and sildenafil citrate following administration of a sublingual solution of testosterone with an encapsulated tablet versus a combination product.Secondary objective:To investigate…
Primary objectives:To confirm the lack of effect of 0.5 mg sublingual testosterone on physiological and subjective measures of sexual arousal in women with HSDD. Secondary objective:To confirm the lack of effect of 0.5 mg sublingual testosterone on…
PRIMARY OBJECTIVEPart 1: Safety Run-in PhaseThe primary objective for Part 1 of this study is to determine the safety and tolerability of pertuzumab in combination with either topotecan or paclitaxel.Part 2The primary objective for Part 2 of this…
The objective of this study is to investigate the safety and efficacy of pertuzumab in combination with standard therapy, trastuzumab and a taxane.
To compare the efficacy of six cycles neoadjuvant PTC plus pertuzumab preceded by either three cycles of FEC-T plus pertuzumab or three cycles of PTC plus pertuzumab in HER2 positive breast cancerSecondary objectives• To describe the safety of the…
Primary objectivesThe primary objective of this trial is to evaluate the efficacy in terms of overall survival (OS) at 24 months of a chemotherapy-free dual HER2-inbibition with trastuzumab and pertuzumab (first-line) followed by T-DM1 (second-line…
The main objectives are to evaluate the efficacy (as measured byprogression free survival at 6 months) of pertuzumab combined withtrastuzumab (PH) or PH plus metronomic chemotherapy (PHM) in anelderly metastatic breast cancer population, and to…
Assess the feasibility of preoperative treatment with pertuzumab and trastuzumab combined with preoperative chemoradiation (carboplatin, paclitaxel and radiation) in terms of withdrawal rate from surgery
Primary Objective• To validate the existing demarcation formula (consisting of psychometric and biological markers) which predicts the sensitivity to Lybrido or Lybridos in women with female sexual interest/arousal disorder (FSIAD with or without…
To compare the number of responders to vaccination with the influenza virus vaccine and pneumococcal vaccine at different time points in treatment cycle of lenalidomide. Secondly to study the immune-response to vaccination, during treatment with…
The aim of this study is to investigate immune response to pneumococcal vaccination in patients after community acquired pneumonia with S. pneumoniae compared to pneumonia patients with another pathogen.
Pertuzumab is the investigational agent being studied for the treatment of HER2-positive gastric cancer. This study is to compare the overall survival (OS) in patients treated with pertuzumab in addition to trastuzumab (Herceptin®) plus cisplatin…
To compare the number of responders to vaccination with pneumococcal and conjugated Hib vaccine at different time points after last dose of rituximab, to investigate what the ideal moment of vaccination would be. Secondly to study the immune-…
Primary objective1. To determine the effect of food on the pharmacokinetics of buspirone administered as the Lybridos formulationSecondary objective1. To evaluate the safety and tolerability of a single dose of Lybridos under fasted and fed…
Primary objective1. To determine the effect of food on the pharmacokinetics of sildenafil administered as the Lybrido formulation2. To determine whether >90% of the testosterone content is released after maximally 90 seconds after sublingual…
This study will investigate the counter impulse hypothesis. According to the counter-impulse hypothesis, avoidance motivation counters aggressive impulses. Consequently, this regulatory impact should be especially effective when people*s aggressive…
To increase the major pathological response rate (< 10% vital tumor cells) to neoadjuvant treatment by integrating both trastuzumab and pertuzumab into perioperative chemotherapy for HER-2 positive, resectable gastric cancer.