scholarly journals Influence of Lisdexamfetamine Dimesylate on Early Ejaculation—Results from a Double-Blind Randomized Clinical Trial

Healthcare ◽  
2021 ◽  
Vol 9 (7) ◽  
pp. 859
Author(s):  
Mohammad Haghighi ◽  
Mona Doostizadeh ◽  
Leila Jahangard ◽  
Alireza Soltanian ◽  
Mohammad Faryadres ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Psychological Factors ◽  
Marital Relationships ◽  
Vaginal Intercourse ◽  
Lisdexamfetamine Dimesylate ◽  
Placebo Condition ◽  
Double Blind ◽  
Female Partners ◽  
Study Participants

Background: Among male sexual dysfunctions, erectile dysfunction and early ejaculation have the highest prevalence rates. Here, we tested the influence of lisdexamfetamine dimesylate (Vyas®) on early ejaculation. To this end, we performed a double-blind randomized clinical trial among males with early ejaculation. Methods: A total of 46 males with early ejaculation (mean age: 35.23 years) and in stable marital relationships with regular weekly penile–vaginal intercourse were randomly assigned either to the lisdexamfetamine dimesylate condition (30 mg) or to the placebo condition. Compounds were taken about six hours before intended penile–vaginal intercourse. At baseline and four weeks later at the end of the study, participants completed a series of self-rating questionnaires covering early ejaculation. Female partners also rated participants’ early ejaculation profile. Results: Compared to the placebo condition, dimensions of early ejaculation improved over time in the lisdexamfetamine condition, though improvements were also observed in the placebo condition. Conclusions: Among male adults in stable marital relationships with regular weekly penile–vaginal intercourse, lisdexamfetamine dimesylate improved dimensions of early ejaculation. Given that improvements were also observed in the placebo condition, psychological factors such as increased attention to early ejaculation and favorable expectations of the compound should be considered.

scholarly journals Rationale and study-design of a randomized, placebo-controlled, double-blind phase 2b trial to Evaluate Efficacy, Safety and Tolerability of an oral glutaminyl cyclase inhibitor Varoglutamstat (PQ912) in Study participants With MCI and Mild AD -  VIVIAD

2021 ◽  
Author(s):  
E.G.B. Vijverberg ◽  
T.M. Axelsen ◽  
A.R. Bihlet ◽  
K. Henriksen ◽  
F. Weber ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Small Molecule ◽  
Study Design ◽  
State Of The Art ◽  
Brain Activity ◽  
Double Blind ◽  
Glutaminyl Cyclase ◽  
Disease Characteristics ◽  
Study Participants

Abstract Background: Varoglutamstat (formerly PQ912) is a small molecule that inhibits the activity of the glutaminyl cyclase to reduce the level of pyroglutamate-A-beta (pGluAB42). Recent studies confirm that pGluAB42 is a particular amyloid form that is highly synaptotoxic and plays a significant role in the development of AD. Methods:This paper describes the design and methodology behind the VIVIAD-trial. The aim of this study is to evaluate varoglutamstat in a state-of-the-art phase 2b, placebo-controlled, double-blind, randomized clinical trial on safety and tolerability, efficacy on cognition, brain activity and AD biomarkers. In addition to its main purpose, the trial will explore potential associations between novel and established biomarkers and their individual and composite relation to disease characteristics. Results: to be expected early 2023Conclusion: This state of the art phase 2b study will yield important results for the field and the treatment of AD with a small molecule directed against pyroglutamate-A-beta.

scholarly journals Rationale and study design of a randomized, placebo-controlled, double-blind phase 2b trial to evaluate efficacy, safety, and tolerability of an oral glutaminyl cyclase inhibitor varoglutamstat (PQ912) in study participants with MCI and mild AD—VIVIAD

2021 ◽  
Vol 13 (1) ◽  
Author(s):  
E. G. B. Vijverberg ◽  
T. M. Axelsen ◽  
A. R. Bihlet ◽  
K. Henriksen ◽  
F. Weber ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Small Molecule ◽  
State Of The Art ◽  
Brain Activity ◽  
Trial Methodology ◽  
Double Blind ◽  
Glutaminyl Cyclase ◽  
Disease Characteristics ◽  
Study Participants

Abstract Background Varoglutamstat (formerly PQ912) is a small molecule that inhibits the activity of the glutaminyl cyclase to reduce the level of pyroglutamate-A-beta (pGluAB42). Recent studies confirm that pGluAB42 is a particular amyloid form that is highly synaptotoxic and plays a significant role in the development of AD. Methods This paper describes the design and methodology behind the phase 2b VIVIAD-trial in AD. The aim of this study is to evaluate varoglutamstat in a state-of-the-art designed, placebo-controlled, double-blind, randomized clinical trial for safety and tolerability, efficacy on cognition, and effects on brain activity and AD biomarkers. In addition to its main purpose, the trial will explore potential associations between novel and established biomarkers and their individual and composite relation to disease characteristics. Results To be expected early 2023 Conclusion This state of the art phase 2b study will yield important results for the field with respect to trial methodology and for the treatment of AD with a small molecule directed against pyroglutamate-A-beta. Trial registration ClinicalTrials.gov Identifier: NCT04498650

Comparing Intradermal Sterile Water with Intravenous Morphine in Reducing Pain in Patients with Renal Colic: A Double-Blind Randomized Clinical Trial

2020 ◽  
Vol 15 (1) ◽  
pp. 76-82
Author(s):  
Javad Mozafari ◽  
Mohammadreza Maleki Verki ◽  
Fatemeh Tirandaz ◽  
Reza Mahjouri
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Renal Colic ◽  
Therapeutic Effects ◽  
Sterile Water ◽  
Morphine Group ◽  
Double Blind ◽  
Water Group ◽  
Intravenous Morphine ◽  
Painful Area

Objective: The present study was conducted to investigate the effect of intradermal administration of sterile water compared to intravenous morphine on patients with renal colic. Methods: This double-blind, randomized clinical trial study was conducted in 2017 to compare the therapeutic effects of intradermal sterile water with those of intravenous morphine on patients with renal colic presenting to the emergency departments (ED) of Imam Khomeini and Golestan Hospitals in Ahvaz, Iran. The first group received 0.5 ml of intradermal sterile water, and the second group 0.1mg/kg of intravenous morphine plus 0.5 ml of intradermal sterile water in the most painful area or the center of the painful area in the flank. The pain severity was measured using a visual analogue scale (VAS), and the medication side-effects were recorded at the beginning of the study and minutes 15, 30,45 and 60. Result: A total of 94 patients were studied in two groups. The mean severity of pain was 2.97 ± 1.51 in the sterile water group and 2.34 ± 1.89 in the morphine group at minute 30 (P=0.042), 2.58 ± 1.43 in the sterile water group and 1 ± 1.23 in the morphine group at minute 45 (p<0.001), and 1.89 ± 1.7 in the sterile water group and 0.52 ± 0.79 in the morphine group at minute 60 (p<0.001). Conclusion: Morphine reduces pain faster and more effectively than intradermal sterile water; nevertheless, treatment with intradermal sterile water can be used as an appropriate surrogate or adjunct therapy for pain control, particularly in special patients or in case of medication scarcity.

Short‐term efficacy of a gel containing propolis extract, nanovitamin C and nanovitamin E on peri‐implant mucositis: A double‐blind, randomized, clinical trial

2021 ◽  
Author(s):  
José González‐Serrano ◽  
Rosa María López‐Pintor ◽  
Julia Serrano ◽  
Jesús Torres ◽  
Gonzalo Hernández ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Short Term ◽  
Double Blind ◽  
Propolis Extract ◽  
Term Efficacy
Sign in / Sign up

Export Citation Format

Share Document