A phase III, single-arm, 6-month trial of a wide-dose range oral testosterone undecanoate product

JS Bernstein, OP Dhingra - Therapeutic Advances in …, 2024 - journals.sagepub.com
… Participants were either naïve to androgen therapy or were … normal range (based on phase
II clinical results) and estimating … dose) approach coupled with a novel formulation met FDA …

Hypogonadism in male infants and adolescents: New androgen formulations

L Chioma, M Cappa - Hormone Research in Paediatrics, 2023 - karger.com
… Several studies have demonstrated the effects of testosterone … More recent phases II and
III pharmacokinetic studies have … This component combination provides a prolonged IM

[HTML][HTML] Orteronel for metastatic hormone-sensitive prostate cancer: a multicenter, randomized, open-label phase III trial (SWOG-1216)

…, NJ Vogelzang, IM Thompson Jr… - Journal of Clinical …, 2022 - ncbi.nlm.nih.gov
… , a novel androgen axis inhibitor, to androgen deprivation … Phase II study of single-agent
orteronel (TAK-700) in patients … and castrate levels of testosterone: Recommendations of the …

Developments and challenges for new and emergent preparations for male hypogonadism treatment

G Corona, C Sparano, G Rastrelli… - Expert Opinion on …, 2023 - Taylor & Francis
… (DHT), an androgen formed by testosterone (T) reduction … analysis of a multicenter,
open-label, dose-ranging phase 3 … Nonetheless, it appears that the intramuscular T enanthate or …

Development of new hormonal male contraception for the couple

JM Kroopnick, MS Lee, DL Blithe - Andrology, 2024 - Wiley Online Library
novel transdermal gel containing testosterone and segesterone acetate (Nestorone), a progestin.
An ongoing phase II studyIntramuscular testosterone undecanoate and norethisterone …

… , safety, and antitumor effect of apalutamide with abiraterone acetate plus prednisone in metastatic castration-resistant prostate cancer: phase Ib study

EM Posadas, KN Chi, R de Wit, MJA de Jonge… - … Cancer Research, 2020 - AACR
… (CRPC) receiving androgen deprivation therapy and for … This multicenter, open-label, phase
Ib drug–drug interaction … despite surgical or medical castration (testosterone levels of <50 ng/…

Novel androgen therapies including selective androgen receptor modulators

J Kang, R Chen, T Tharakan, S Minhas - Best Practice & Research Clinical …, 2022 - Elsevier
… , and novel therapies including nasal testosterone, aromatase … further study found that weekly
intramuscular 200 mg testosterone … These findings are supported by a phase II multicentre, …

Androgen treatment in adolescent males with hypogonadism

RA Rey, RP Grinspon - American Journal of Men's Health, 2020 - journals.sagepub.com
… hypogonadism needing continued androgen therapy, the dosage of IM testosterone enanthate
or … Daily oral administration of the novel androgen 11beta-MNTDC markedly suppresses …

Safety aspects and rational use of testosterone undecanoate in the treatment of testosterone deficiency: clinical insights

K Campbell, A Muthigi, A Ghomeshi… - Drug, Healthcare and …, 2023 - Taylor & Francis
… -carbon long androgen ester derivative of testosterone that comes … Unique to the intramuscular
(IM) injection of testosterone … The initial, multicenter, open-label clinical trial investigated …

A phase Ib/II study of the CDK4/6 inhibitor ribociclib in combination with docetaxel plus prednisone in metastatic castration-resistant prostate cancer

I De Kouchkovsky, A Rao, BA Carneiro, L Zhang… - … Cancer Research, 2022 - AACR
… Patients had chemotherapy-naïve mCRPC with progression on ≥ 1 androgen receptor …
This was a phase Ib/II multicenter, open-label study of ribociclib in combination with docetaxel …