scholarly journals Open-label phase IV clinical trial to evaluate the effect of nasal testosterone gel on reproductive hormones and semen parameters in hypogonadal men

2019 ◽  
Vol 112 (3) ◽  
pp. e434-e435
Author(s):  
Thomas A. Masterson ◽  
Joshua N. Bitran ◽  
Manuel Molina ◽  
Emad Ibrahim ◽  
Ursula Kaiser ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Reproductive Hormones ◽  
Semen Parameters ◽  
Open Label ◽  
Testosterone Gel ◽  
Open Label Phase ◽  
Phase Iv

scholarly journals Comparison of safety and efficacy of dextromethorphan and levocloperastine in treatment of dry cough: a randomized open label phase IV clinical trial

2019 ◽  
Vol 8 (10) ◽  
pp. 2284
Author(s):  
Arijit Ghosh
Keyword(s):  
Clinical Trial ◽  
Selection Criteria ◽  
Open Label ◽  
Safety And Efficacy ◽  
Leicester Cough Questionnaire ◽  
Open Label Phase ◽  
Group A ◽  
Group B ◽  
Phase Iv

Background: To compare safety and efficacy of dextromethorphan and levocloperastine in treatment of dry cough.Methods: Patients fulfilling the selection criteria were randomized into two groups. Patients in group A were administered dextromethorphan cough lozenges (5 mg) thrice daily for 7 days. Patients in group B were administered syrup levocloperastine (20 mg/5 ml) 5 ml thrice daily for 7 days. Severity and frequency of cough, and Leicester Cough Questionnaire (LCQ) score were assessed at the end of day 7.Results: Levocloperastine significantly decreased (p<0.5) severity and frequency of cough compared to dextromethorphan at day 7. Levocloperastine also significantly increased LCQ score compared to dextromethorphan at day 7.Conclusions: Levocloperastine is significantly more effective compared to dextromethorphan in treatment of dry cough. 

Immunogenicity and safety of different sequential schedules of Sabin strain-based inactivated poliovirus vaccination: A randomized, controlled, open-label, phase IV clinical trial in China

Vaccine ◽  
2020 ◽  
Vol 38 (40) ◽  
pp. 6274-6279
Author(s):  
Shaohong Yan ◽  
Haiping Chen ◽  
Zhenguo Zhang ◽  
Shaoying Chang ◽  
Yanhui Xiao ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Open Label ◽  
Randomized Controlled ◽  
Open Label Phase ◽  
Phase Iv

scholarly journals SAT-034 The Effect of Natesto on Spermatogenesis, Reproductive Hormones, and Hypogonadal Symptoms. A Phase IV Study

2020 ◽  
Vol 4 (Supplement_1) ◽  
Author(s):  
Thomas A Masterson ◽  
Jordan Best ◽  
Josh Bitran ◽  
Manuel L Molina ◽  
Emad Ibrahim ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Short Form ◽  
Sperm Concentration ◽  
Reproductive Hormones ◽  
Semen Parameters ◽  
Short Acting ◽  
Nasal Irritation ◽  
Sf 36 ◽  
Testis Volume ◽  
Phase Iv

Abstract INTRODUCTION AND OBJECTIVE: Exogenous testosterone (T) therapy is typically long-acting and causes azoospermia in up to 65% of the men. Natesto, dosed three times a day, is a short-acting, FDA approved nasal testosterone available since 2015. We hypothesized that Natesto can preserve spermatogenesis due to its short-acting property. METHODS: We prospectively enrolled hypogonadal men aged 18-55 years with two serum T levels &lt; 300 ng/dL (drawn before 10 AM), symptoms, and 2 semen analyses (SA) with total motile sperm counts (TMSC) &gt; 5 million in a phase IV clinical trial. Eligible men received Natesto for 6 months. Serum T, luteinizing hormone (LH), follicle stimulating hormone (FSH), 17-hydroxyprogesterone (17-OHP), 2 SA, and testis volume were collected at baseline and after 3 and 6 months of therapy. Symptoms were evaluated using the international index of erectile function 6 (IIEF-6) and the short form 36 (SF-36) questionnaires. The primary endpoints were change in T, LH, FSH, sperm concentration, sperm motility, and TMSC. Secondary end points were change in symptoms, testis volume, and adverse events (AEs). Data are presented as means (SD), t-test was used to compare changes after 3 and 6 months, p&lt;0.05 was considered significant. RESULTS: In total, 102 men were screened, and 60 men (age 19-55 years) enrolled. Of the 60 men, 44 completed 3 months, 33 completed 6 months, and 17 dropped out. Mean serum T increased from hypogonadal at baseline to 3 and 6 months (p=0.005), LH and FSH decreased (p=0.03) but remained within the normal range (2-5 IU/mL). Most importantly, semen parameters remained unchanged after 3 and 6 months of T therapy. Only 3 (7.5%) men had severe oligospermia and one (2.5%) became azoospermic but recovered at 6 months after discontinuation. Testis volume and intratesticular T (serum 17-OHP) were maintained at 3 and 6 months. There was improvement across all sub-domains of the IIEF as well as improvement in questions related to energy in the SF-36. A total of 10 men dropped out due to nasal irritation. CONCLUSIONS: This phase IV clinical trial demonstrated that Natesto increased serum T, improved hypogonadal symptoms, maintained gonadotropins, testis volume, intratesticular testosterone and semen parameters. Natesto, and other short acting forms of testosterone therapy may help hypogonadal men maintain fertility.

REGOMA: A Randomized, Multicenter, Controlled Open-Label Phase II Clinical Trial of Regorafenib Compared to Lomustine in Relapsed Glioblastoma Patients

2018 ◽  
Author(s):  
Giuseppe Lombardi ◽  
Gian Luca De Salvo ◽  
Alba Ariela Brandes ◽  
Marica Eoli ◽  
Roberta Rudà ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Phase Ii ◽  
Phase Ii Clinical Trial ◽  
Open Label ◽  
Open Label Phase

scholarly journals Managing pasireotide-associated hyperglycemia: a randomized, open-label, Phase IV study

Pituitary ◽  
2021 ◽  
Author(s):  
Susan L. Samson ◽  
Feng Gu ◽  
Ulla Feldt-Rasmussen ◽  
Shaoling Zhang ◽  
Yerong Yu ◽  
...  
Keyword(s):  
Cushing’S Disease ◽  
Rescue Therapy ◽  
Antidiabetic Drugs ◽  
Cushing's Disease ◽  
Oral Antidiabetic Drugs ◽  
Open Label ◽  
Oral Antidiabetic ◽  
Open Label Phase ◽  
Core Phase ◽  
Phase Iv

Abstract Purpose Pasireotide is an effective treatment for acromegaly and Cushing’s disease, although treatment-emergent hyperglycemia can occur. The objective of this study was to assess incretin-based therapy versus insulin for managing pasireotide-associated hyperglycemia uncontrolled by metformin/other permitted oral antidiabetic drugs. Methods Multicenter, randomized, open-label, Phase IV study comprising a core phase (≤ 16-week pre-randomization period followed by 16-week randomized treatment period) and optional extension (ClinicalTrials.gov ID: NCT02060383). Adults with acromegaly (n = 190) or Cushing’s disease (n = 59) received long-acting (starting 40 mg IM/28 days) or subcutaneous pasireotide (starting 600 µg bid), respectively. Patients with increased fasting plasma glucose (≥ 126 mg/dL on three consecutive days) during the 16-week pre-randomization period despite metformin/other oral antidiabetic drugs were randomized 1:1 to open-label incretin-based therapy (sitagliptin followed by liraglutide) or insulin for another 16 weeks. The primary objective was to evaluate the difference in mean change in HbA1c from randomization to end of core phase between incretin-based therapy and insulin treatment arms. Results Eighty-one (32.5%) patients were randomized to incretin-based therapy (n = 38 received sitagliptin, n = 28 subsequently switched to liraglutide; n = 12 received insulin as rescue therapy) or insulin (n = 43). Adjusted mean change in HbA1c between treatment arms was – 0.28% (95% CI – 0.63, 0.08) in favor of incretin-based therapy. The most common AE other than hyperglycemia was diarrhea (incretin-based therapy, 28.9%; insulin, 30.2%). Forty-six (18.5%) patients were managed on metformin (n = 43)/other OAD (n = 3), 103 (41.4%) patients did not require any oral antidiabetic drugs and 19 patients (7.6%) were receiving insulin at baseline and were not randomized. Conclusion Many patients receiving pasireotide do not develop hyperglycemia requiring oral antidiabetic drugs. Metformin is an effective initial treatment, followed by incretin-based therapy if needed. ClinicalTrials.gov ID: NCT02060383.

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