acyline (MER-104) / Merrion - LARVOL DELTA

ITT-5 Mechanisms of Spermatogenesis in Man (clinicaltrials.gov) - P2; N=0; Withdrawn; Sponsor: University of Washington; N=60 ➔ 0; Not yet recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal

ITT-5 Mechanisms of Spermatogenesis in Man (clinicaltrials.gov) - P2; N=60; Not yet recruiting; Sponsor: University of Washington; Trial completion date: Dec 2025 ➔ Dec 2026; Trial primary completion date: Dec 2020 ➔ Dec 2021

Trial completion date • Trial primary completion date • Biosimilar

Quantitative bidimentional and Doppler ultrasound assessment of the effect of a GnRH antagonist on canine prostatic hyperplasia. (PubMed, Theriogenology) - "The objectives of this article were: a) To describe the effect of a single administration of the third generation GnRH antagonist, acyline, on canine benign prostatic hyperplasia (BPH) b)To quantitatively compare parenchyma echogenicity, heterogeneity (SD echogenicity) and blood flow in hyperplastic and treated prostate glands...It was concluded that a single administration of a third generation GnRH antagonist safely decreased prostatic volume and parenchyma and blood flow abnormities associated with canine BPH during 30 days. Monthly administrations of this treatment could represent a rapid, efficient and safe therapeutic option for BPH."

Journal • Benign Prostatic Hyperplasia

Selection of fewer dominant follicles in Trio carriers given GnRH antagonist and LH action replaced by nonpulsatile hCG.†. (PubMed, Biol Reprod) - "Finally, Acyline+hCG decreased (P < 0.0001) the number of DF from 2.7 ± 0.2 to 1.3 ± 0.2 in Trio carriers, with most heifers having only one DF. This demonstrates the necessity for LH in acquisition of dominance in Trio carriers (~6.5 mm) and noncarriers (~8.5 mm) and provides evidence for a role of GnRH-induced FSH/LH pulses in selection of multiple DF in Trio carriers and possibly other physiologic situations with increased ovulation rate."

Journal

Role for Kisspeptin and Neurokinin B in Regulation of Luteinizing Hormone and Testosterone Secretion in the Fetal Sheep. (PubMed, Endocrinology) - "Pretreatment with the GnRH receptor antagonist (acyline) abolished the LH response to KP-10, confirming a hypothalamic site of action...FISH revealed that the majority of these were kisspeptin/NKB/dynorphin (KNDy) neurons. These results support the hypothesis that kisspeptin-GnRH signaling regulates the reproductive axis of the ovine fetus during the prenatal critical period acting to maintain a stable androgen milieu necessary for brain masculinization."

Journal • Anesthesia

Necessity for LH in selection and continued growth of the bovine dominant follicle. (PubMed, Reproduction) - "Circulating FSH was greater in Acyline than Controls, but lower in Acyline+hCG than Controls after day 1.5. In conclusion, dominant follicle selection and growth after follicle deviation is due to LH action as shown by inhibition of this process during ablation of GnRH-stimulated LH pulses with Acyline and restoration of it after replacement of LH action by hCG treatment."

Journal

PROS-2 Dose Response Effects of Exogenous Testosterone on the Prostate (clinicaltrials.gov) - P2/3; N=72; Recruiting; Sponsor: University of Washington; Not yet recruiting ➔ Recruiting

Enrollment open

PROS-2 Dose Response Effects of Exogenous Testosterone on the Prostate (clinicaltrials.gov) - P2/3; N=62; Completed; Sponsor: University of Washington; Active, not recruiting ➔ Completed

Trial completion

PROS-2 Dose Response Effects of Exogenous Testosterone on the Prostate (clinicaltrials.gov) - P2/3; N=72; Active, not recruiting; Sponsor: University of Washington; Trial completion date: Dec 2014 ➔ Dec 2015

Trial completion date

PROS-2 Dose Response Effects of Exogenous Testosterone on the Prostate (clinicaltrials.gov) - P2/3; N=72; Active, not recruiting; Sponsor: University of Washington; Recruiting ➔ Active, not recruiting

Enrollment closed

PROS-2 Dose Response Effects of Exogenous Testosterone on the Prostate (clinicaltrials.gov) - P2/3; N=72; Recruiting; Sponsor: University of Washington; Initiation date: Jun 2011 ➔ Oct 2011

Trial initiation date

Development of the "waveless" bovine model. (PubMed, Anim Reprod Sci) - "In conclusion, long-term acyline treatment blocks follicular waves but not growth of preantral and small antral follicles (≤ 3 mm). Future studies will determine if the waveless bovine model, which has enhanced development of preantral and small antral follicles, can be used to develop new methods to improve predictability of response of cattle to superovulation."

Journal

Evidence of a Role for Kisspeptin in Regulation of LH and Testosterone Secretion in the Ovine Fetus (ENDO 2019) - "...The LH discharge elicited by KP-10 was abolished by pretreatment with the GnRH receptor antagonist acyline (30 µg, i.m.) confirming a hypothalamic site of action...Furthermore, they suggest that kisspeptin neurons are targets of negative feedback regulation by T in males apparently to help maintain a stable androgen milieu needed for brain masculinization. Supported by NIH Grant OD11047 to CR."