- |||||||||| Natesto (testosterone) / Acerus, Medac, Aytu BioPharma
A CASE OF ANAPHYLAXIS TO CARDIAC ULTRASOUND ENHANCING AGENT (Monitor 2; Hall A) - Sep 29, 2024 - Abstract #ACAAI2024ACAAI_876;
Risk of hypersensitivity reaction with UAEs should be considered in selection of cardiac imaging modalities. Anaphylactic/ anaphylactoid reactions can occur with administration of UAEs in patients without allergy to PEG and should prompt evaluation for conditions predisposing to anaphylaxis, including HaT and systemic mastocytosis.
- |||||||||| Natesto (testosterone) / Acerus, Medac, Aytu BioPharma
Retrospective data, Journal: Trabecular bone score and bone frailty: an Italian observational retrospective study. (Pubmed Central) - Sep 20, 2024
Our results seem to suggest that low level of TBS may detect patients that could be more prone to bone frailty consistently with age and BMD at both vertebral and cortical level. However, its role in clinical practice should be refined.
- |||||||||| Natesto (testosterone) / Acerus, Medac, Aytu BioPharma
Journal: A UTP3-dependent nucleolar translocation pathway facilitates pre-rRNA 5'ETS processing. (Pubmed Central) - Jul 22, 2024
For the remaining 25 proteins we found that UTP3/SAS10 assists the nucleolar localization of five proteins (MPP10, UTP25, EMG1 and the two UTP-B components UTP12 and UTP13), likely through its interaction with nuclear importin ?...Mechanistically, we found that UTP3 facilitates the degradation of processed 5'ETS by recruiting the RNA exosome component EXOSC10 to the nucleolus. These findings lay the groundwork for studying the mechanism of cytoplasm-to-nucleolus trafficking of SSU processome components.
- |||||||||| Natesto (testosterone) / Acerus, Medac, Aytu BioPharma
Journal: Multi-scale modelling of location- and frequency-dependent synaptic plasticity induced by transcranial magnetic stimulation in the dendrites of pyramidal neurons. (Pubmed Central) - Jul 15, 2024
The plasticity modelling framework enables precise simulations of LTP-like cellular effects with high spatio-temporal resolution, enhancing the efficiency of parameter screening and the development of plasticity-inducing rTMS protocols. First rigorously validated model of TMS-induced long-term synaptic plasticity in ex- tended neuronal dendrites that goes beyond point-neuron and mean-field modellingRobust simulations of experimental data on LTP-like plasticity in the proximal dendrites of CA1 hippocampal pyramidal cells evoked by 10 Hz repetitive magnetic stimulation (rMS)Replication of distal synaptic plasticity for a local electrical theta burst stimulation (TBS) protocolPrediction of distal and proximal LTP-like plasticity for rMS TBS1 Hz rMS does not induce long-term depression.
- |||||||||| Natesto (testosterone) / Acerus, Medac, Aytu BioPharma
Journal: Acetylation of transcription factor BpTCP20 by acetyltransferase BpPDCE23 modulates salt tolerance in birch. (Pubmed Central) - Jun 28, 2024
Chromatin immunoprecipitation sequencing showed that BpTCP20 binds to NeuroD1, T-box, and two unknown elements (termed TBS1 and TBS2) to regulate target genes...In addition, we identified dihydrolipoyllysine-residue acetyltransferase component of pyruvate dehydrogenase complex (BpPDCE23), an acetyltransferase that interacts with and acetylates BpTCP20 to enhance its binding to DNA motifs. Together, these results suggest that BpTCP20 is a transcriptional regulator of salt tolerance, whose activity is modulated by BpPDCE23-mediated acetylation.
- |||||||||| Natesto (testosterone) / Acerus, Medac, Aytu BioPharma
Trial completion date, Trial primary completion date: Natesto Spermatogenesis Reboot (clinicaltrials.gov) - Apr 25, 2024
P4, N=30, Recruiting,
Together, these results suggest that BpTCP20 is a transcriptional regulator of salt tolerance, whose activity is modulated by BpPDCE23-mediated acetylation. Trial completion date: Jan 2024 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Dec 2024
- |||||||||| Natesto (testosterone) / Acerus, Medac, Aytu BioPharma
Enrollment change, Trial withdrawal: The Effects of Natesto For Treatment Of Hypogonadism (clinicaltrials.gov) - Apr 23, 2024
P1, N=0, Withdrawn,
Trial completion date: Jan 2024 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Dec 2024 N=40 --> 0 | Not yet recruiting --> Withdrawn
- |||||||||| Natesto (testosterone) / Acerus, Medac, Aytu BioPharma
Enrollment open: Testosterone and Neural Function (clinicaltrials.gov) - Apr 7, 2024
P1, N=15, Recruiting,
N=40 --> 0 | Not yet recruiting --> Withdrawn Not yet recruiting --> Recruiting
- |||||||||| Natesto (testosterone) / Acerus, Medac, Aytu BioPharma
Trial completion, Enrollment change, Trial completion date, Trial primary completion date, Adverse events: A Comparison of Side Effects in Hypogonadal Men Treated With Natesto Versus Testosterone Injections (clinicaltrials.gov) - Dec 13, 2023
P4, N=81, Completed,
To sum up, our findings strongly suggest that clinical application of TBSM1 may serve as a vasoactive drug treatment to suppress tumor progression. Active, not recruiting --> Completed | N=200 --> 81 | Trial completion date: Jun 2024 --> Feb 2023 | Trial primary completion date: Dec 2023 --> Feb 2023
- |||||||||| Natesto (testosterone) / Acerus, Medac, Aytu BioPharma
New P1 trial: Testosterone and Neural Function (clinicaltrials.gov) - Nov 14, 2023
P1, N=15, Not yet recruiting,
- |||||||||| Natesto (testosterone) / Acerus, Medac, Aytu BioPharma
Enrollment change, Trial termination: Evaluation of Testosterone Nasal Gel in Hypogonadal Boys (clinicaltrials.gov) - Oct 26, 2023
P1, N=8, Terminated,
Active, not recruiting --> Completed | N=200 --> 81 | Trial completion date: Jun 2024 --> Feb 2023 | Trial primary completion date: Dec 2023 --> Feb 2023 N=20 --> 8 | Unknown status --> Terminated; Lack of patients and commercial reasons
- |||||||||| Natesto (testosterone) / Acerus, Medac, Aytu BioPharma
Enrollment open, Trial completion date, Trial primary completion date: Natesto Spermatogenesis Reboot (clinicaltrials.gov) - May 22, 2023
P4, N=30, Recruiting,
N=20 --> 8 | Unknown status --> Terminated; Lack of patients and commercial reasons Not yet recruiting --> Recruiting | Trial completion date: Jun 2023 --> Jan 2024 | Trial primary completion date: Jun 2023 --> Dec 2023
- |||||||||| Natesto (testosterone) / Acerus, Medac, Aytu BioPharma
Trial completion date, Trial primary completion date, Adverse events: A Comparison of Side Effects in Hypogonadal Men Treated With Natesto Versus Testosterone Injections (clinicaltrials.gov) - May 12, 2023
P4, N=200, Active, not recruiting,
Not yet recruiting --> Recruiting | Trial completion date: Jun 2023 --> Jan 2024 | Trial primary completion date: Jun 2023 --> Dec 2023 Trial completion date: Dec 2023 --> Jun 2024 | Trial primary completion date: Jun 2023 --> Dec 2023
- |||||||||| Natesto (testosterone) / Acerus, Medac, Aytu BioPharma
Trial completion date, Trial primary completion date: The Effects of Natesto For Treatment Of Hypogonadism (clinicaltrials.gov) - May 11, 2023
P1, N=40, Not yet recruiting,
Trial completion date: Dec 2023 --> Jun 2024 | Trial primary completion date: Jun 2023 --> Dec 2023 Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Dec 2024
- |||||||||| Natesto (testosterone) / Acerus, Medac, Aytu BioPharma
Journal: UTP11 deficiency suppresses cancer development via nucleolar stress and ferroptosis. (Pubmed Central) - May 7, 2023
In this study, we found that UTP11 plays an important role in the biosynthesis of 18S ribosomal RNAs (rRNA) by binding to the pre-rRNA processing factor, MPP10...On the other hand, UTP11 deficiency represses the expression of SLC7A11 by promoting the decay of NRF2 mRNA, resulting in reduced levels of glutathione (GSH) and enhanced ferroptosis. Altogether, our study uncovers a critical role for UTP11 in maintaining cancer cell survival and growth, as depleting UTP11 leads to p53-dependent cancer cell growth arrest and p53-independent ferroptosis.
- |||||||||| Natesto (testosterone) / Acerus, Medac, Aytu BioPharma
Enrollment change, Trial completion date, Trial withdrawal, Trial primary completion date: Natesto Testosterone Nasal Gel for Hypogonadal Men (clinicaltrials.gov) - Dec 21, 2022
P4, N=0, Withdrawn,
Altogether, our study uncovers a critical role for UTP11 in maintaining cancer cell survival and growth, as depleting UTP11 leads to p53-dependent cancer cell growth arrest and p53-independent ferroptosis. N=50 --> 0 | Trial completion date: Jun 2026 --> Apr 2025 | Not yet recruiting --> Withdrawn | Trial primary completion date: Jun 2025 --> Jan 2024
- |||||||||| Natesto (testosterone) / Acerus, Medac, Aytu BioPharma
Trial completion date, Trial primary completion date, Adverse events: A Comparison of Side Effects in Hypogonadal Men Treated With Natesto Versus Testosterone Injections (clinicaltrials.gov) - Dec 16, 2022
P4, N=200, Active, not recruiting,
N=50 --> 0 | Trial completion date: Jun 2026 --> Apr 2025 | Not yet recruiting --> Withdrawn | Trial primary completion date: Jun 2025 --> Jan 2024 Trial completion date: Dec 2022 --> Dec 2023 | Trial primary completion date: Dec 2022 --> Jun 2023
- |||||||||| Natesto (testosterone) / Acerus, Medac, Aytu BioPharma
Trial initiation date: Natesto Testosterone Nasal Gel for Hypogonadal Men (clinicaltrials.gov) - Nov 8, 2022
P4, N=50, Not yet recruiting,
No abstract available Initiation date: Sep 2022 --> Jan 2023
- |||||||||| Natesto (testosterone) / Acerus, Medac, Aytu BioPharma
Antenatal kidneys hypoplasia reveals a new variant of Townes-Brocks syndrome-1. (Poster Area - Exhibition Hall E) - Sep 20, 2022 - Abstract #IPNA2022IPNA_254;
Kidney structural abnormalities (hypoplasia, dysplasia, polycystic kidneys), sometimes leading to kidney failure, have already been reported but seldom as the main impairment especially during childhood. TBS-1 should be suspected in antenatally diagnosed kidneys hypoplasia.
- |||||||||| Natesto (testosterone) / Acerus, Medac, Aytu BioPharma
Journal: An 86 amino acids motif in CAPN3 is essential for formation of the nucleolus-localized Def-CAPN3 complex. (Pubmed Central) - Aug 24, 2022
This complex mediates the degradation of the tumor suppressor p53 and ribosome biogenesis factor mitotic phosphorylated protein 10 (Mpp10) in nucleolus, demonstrating the importance of this complex in regulating cell cycle and ribosome biogenesis...We further identify the 2/3 C-terminus of hDef is responsible for mediating the hDef-hCAPN3 interaction, and the corresponding region is conserved for the zDef and zCapn3b interaction. Our results lay the ground to resolve the structure of the Def-CAPN3 complex in the future.
- |||||||||| Natesto (testosterone) / Acerus, Medac, Aytu BioPharma
Trial completion date, Trial primary completion date: A Study to Monitor Ambulatory Blood Pressure Monitoring in Hypogonadal Men Treated With Nasal Testosterone Gel (clinicaltrials.gov) - Jul 6, 2022
P4, N=218, Recruiting,
Hypogonadal men on long-acting TRT interested in resumption of spermatogenesis may convert directly to Natesto for an opportunity to do so while remaining on a form of TRT and achieving lower E2 levels. Trial completion date: Feb 2022 --> Dec 2022 | Trial primary completion date: Feb 2022 --> Dec 2022
- |||||||||| Natesto (testosterone) / Acerus, Medac, Aytu BioPharma
New P4 trial: Natesto Spermatogenesis Reboot (clinicaltrials.gov) - May 18, 2022
P4, N=30, Not yet recruiting,
- |||||||||| Natesto (testosterone) / Acerus, Medac, Aytu BioPharma
Journal: Converting men from Clomiphene Citrate to Natesto for hypogonadism improves libido, maintains semen parameters, and reduces estradiol. (Pubmed Central) - Feb 3, 2022
Men on CC and Natesto reach eugonadal testosterone levels, however; on CC the E2 level nearly doubled from baseline, and converting men from CC to Natesto returned E2 to nearly baseline levels. There was not a detrimental effect on semen parameters, and there was subjective reporting of improved libido after converting from CC to Natesto in this cohort, but further long-term studies are needed prior to Natesto being established as a definitive treatment for hypogonadism for men desiring to maintain fertility.
- |||||||||| Natesto (testosterone) / Acerus, Medac, Aytu BioPharma
Journal: Men converting from clomiphene citrate to Natesto with a desire to maintain spermatogenesis should be followed closely. (Pubmed Central) - Feb 1, 2022
Testosterone deficient men interested in maintaining spermatogenesis who convert from CC to Natesto seeking a more robust symptomatic response should be followed closely with repeat serum gonadotropins and semen parameters to confirm that spermatogenesis is not being suppressed. Dose titration of Natesto may be effective at optimizing gonadotropins, semen parameter values, testosterone levels, and symptomatic response to treatment.
- |||||||||| Natesto (testosterone) / Acerus, Medac, Aytu BioPharma
Clinical, Journal: Trabecular bone score in women with differentiated thyroid cancer on long-term TSH-suppressive therapy. (Pubmed Central) - Jan 19, 2022
Trabecular microarchitecture assessed by TBS was similar between women on long-term suppressive therapy in DTC and those on LT4 replacement therapy aiming at a TSH level within the low-normal reference range. Low TBS values were observed in postmenopausal women of both groups, suggesting that not only suppressed TSH levels but also a low-normal TSH is associated with deteriorated bone microarchitecture in postmenopausal women following total thyroidectomy.
- |||||||||| Natesto (testosterone) / Acerus, Medac, Aytu BioPharma, Nebido (testosterone undecanoate depot injection) / Bayer
Journal: Jatenzo - an oral testosterone for hypogonadism. (Pubmed Central) - Jul 14, 2021
The wide variation in modalities of testosterone prescriptions illustrates an opportunity for treatment guidelines to be streamlined across all specialties in order to improve outcomes for all patients. No abstract available
- |||||||||| Natesto (testosterone) / Acerus, Medac, Aytu Biosci
Clinical, Journal: Use of trabecular bone score for risk stratification of patients with monoclonal gammopathy of undetermined significance. (Pubmed Central) - Jun 22, 2021
Although fractures occurred more commonly in those control subjects with significantly lower TBS values, this was not the case in subjects with MGUS (TBS 1.299 vs. 1.313 in cases with vs. without fractures p = 0.313)...Despite patients with MGUS having a significantly increased fracture risk compared to age-, sex- and BMI-matched control subjects, neither assessment of BMD nor TBS, obtained within two years of MGUS diagnosis, were able to accurately risk stratify MGUS patients. Unlike control subjects, patients with MGUS tend to fracture despite normal BMD and intermediate or normal TBS values, suggesting that deterioration of cortical rather than trabecular skeletal components may be more important for the increased fracture risk seen in MGUS.
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