Clinical Trials Research® (CTR), located in Lincoln and Sacramento, seeks participants for a clinical trial investigating medication that could help reduce symptoms associated with menopause.
The Health Issue
Menopause (climacteric) is the time in most women’s lives when menstrual periods stop permanently and they can no longer bear children. The condition or milestone typically occurs between 49 and 52 years of age. Symptoms can include hot flashes, sweating, shivering and a reddening of the skin.
The Clinical Research Site
CTR is an investigational site run by Dr. Jeffrey D. Wayne, a board-certified internist who has been practicing medicine since 1992. He has served as a principal investigator in the oversight and coordination of over 260 clinical trials across a wide range of therapeutic areas. Well respected in the global research community, this regional site in the Sacramento, area collaborates with well known biopharma sponsors, CROs, IRBs and others to conduct studies. Dr. Wayne no longer maintains a practice and is 100% focused on clinical trials.
According to the research site’s website they have 17 team members and have enrolled over 1,000 patients at two locations.
Based on this site’s study ad the study focused on the symptom of “hot flashes” in women that have gone through menopause and experience at least one hot flash per day. A 15-month study, this site is recruiting patients to study a hormonal, investigational medication, that could help to reduce symptoms associated with menopause. The research site will provide to qualified participants the trial drug at no cost and may reimburse the patient for travel. This clinical research site doesn’t identify the investigational drug nor the sponsor, however they (CTR) are identified as part of a menopause-based “hot flash” study in ClinicalTrials.gov.
For women in menopause with hot flashes, the purpose of the trial is to evaluate fezolinetant long term. To do that the study will look at the number and severity of the “adverse events.”
What is Fezolinetant?
Fezolinetant is a small-molecule, orally active, selective neurokinin-3 (NK3) receptor antagonist which is under development for the treatment of sex hormone-related disorders. Initially developed by Ogeda, this venture was acquired by Astellas Pharma in 2017. Unlike GnRH modulators, but similarly to estrogens, NK3 receptor antagonists including fezolinetant and MLE-4901 (also known as AZD-4901, formerly AZD-2624) have been found to alleviate hot flashes in menopausal women. This would seem to be independent of their actions on the hypothalamic–pituitary–gonadal axis and hence on sex hormone production. NK3 receptor antagonists are anticipated as a useful clinical alternative to estrogens for management of hot flashes, but with potentially reduced risks and side effects.
Lead Research/Investigator (Sacramento, CA)
Dr. Jeffrey D. Wayne, Clinical Trials Research®