16 results
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 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.…
To compare prostate-specific antigen (PSA) progression-free survival (PFS) failure rates during long-term treatment with 3-monthly subcutaneous (s.c.) injections of degarelix or goserelin in prostate cancer patients (PSA PFS failure is defined as…
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 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 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 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…
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…
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…
The primary objective of the study is to evaluate if treatment with a non-steroidal aromatase inhibitor combined with CDK4/6 inhibition in first line followed at progression by fulvestrant in second line (strategy A) improves progression-free…
To assess the proportion of patients who are alive without disease progression at 6 months based on local investigator assessment per RECIST v1.1 in cohort A and cohort B 13-03-2019: new cohort added (3 cohorts now)
Primary: 1/ To evaluate the safety and tolerability of ribociclib with letrozole in men and postmenopausal women with HR+, HER2- aBC who received no prior hormonal therapy for advanced disease.Secondary: To assess the clinical efficacy of ribociclib…
to assess the efficacy of a 16-week treatment period of low dose amitriptyline (10-20 mg nightly) or mirtazapine (7.5 - 15 mg nightly) on subjective sleep quality compared to placebo added to usual care in patients with insomnia disorder with sleep…
The primary objective is to determine in which percentage of patients with prostate cancer with an indication for ADT, it is safe to extend the dosing interval of goserelin 10,8 mg by four weeks, before the 4th injection, using a testosterone based…
The primary objective of this study is to determine whether SAR439859 in combination with palbociclib improves progression free survival (PFS) compared to letrozole in combination with palbociclib in patients with ER +, HER2-advanced breast cancer…