The trial in question will be conducted by McGill University in Canada. The trial will include 5 statistical analysis statistical analysis and will take place in the largest and only Canadian clinical trial in this area. The trial will follow a program in which twelve women will be in a closed and controlled environment in order to test the effects of cannabis in treating severe menstrual bleeding and endometriosis.
In an article published by the The BMJ, a group of researchers from Australia and the United States have presented a new trial to investigate the use of cannabis based medications in the treatment of chronic pelvic pain.
Research has already shown that cannabis can be used to treat some medical conditions. Unfortunately, cannabis legislation at the federal level creates barriers to research. Recent research in the United States has shown that cannabis can be used to treat some medical conditions, but legislation at the federal level creates barriers to research.
New Israeli clinical studies will look at the safety and effectiveness of cannabis-based therapies for some of the most severe and long-lasting gynecological issues that women experience.
The trials, which are expected to begin in early 2022, will examine cannabis-based pharmacology products developed by Gynica, a Jerusalem-based femtech (female technology) startup that believes the active ingredients in the plant can alleviate painful conditions in the female reproductive system like dysmenorrhea and endometriosis.
In the case of endometriosis, a painful disorder that occurs when tissue similar to that which normally lines the uterus – the endometrium – begins to grow outside the organ, traditional treatments such as over-the-counter painkillers, hormone therapy, and even surgical intervention can be ineffective or even harmful to one’s health.
Gynica claims that through creating cannabis-based treatments for these diseases, company hopes to solve unmet needs in women’s health.
“There are so many gaps in how the medical profession and the scientific community address diseases that impact women,” says Gynica co-founder and CEO Yotam Hod. The company plans to enter the market with patented vaginal suppositories that, according to Hod, will help “reduce discomfort as well as inflammation, which is a key component in endometriosis and dysmenorrhea.”
Endometriosis is a condition in which endometrium-like tissue develops outside of the womb and gets stuck within the body, thickening, breaking down, and bleeding with each menstrual cycle. The tissue, unlike the uterus, has no route out, resulting in a build-up of scar tissue and adhesions that cause a range of symptoms, including painful menstruation and intercourse, heavy bleeding, and in some instances, infertility. Endometriosis, whose origin is unknown and for which there is no known treatment, may take anywhere from six to ten years for physicians to correctly diagnose, despite the fact that it affects approximately one in every ten women of reproductive age (or some 180 million women and girls worldwide).
Dysmenorrhea is also quite prevalent, and the discomfort it causes may range from moderate to severe, leaving some women unable to function for part of their monthly cycle. Dysmenorrhea is common, although the frequency varies considerably, ranging from 45 to 93 percent of women of reproductive age.
For others, the two ailments are intertwined. And for those who seek for the Advil or Aleve, relief may be fleeting.
Dysmenorrhea and endometriosis, according to Gynica, are linked to a deficiency in the endocannabinoid system (ECS), which regulates a wide range of processes including pain, memory, mood, metabolism, appetite, sleep, and reproductive function.
According to the British Journal of Pharmacology, the female reproductive system has the most endocannabinoid receptors in the body after the brain, and the company thinks that “cannabinoids are the missing component in the treatment of gynecological disorders.”
“Like everywhere else in the body, the ECS plays a complicated homeostatic function in the female reproductive tract,” says Dr. Codi Peterson, a pharmacist and cannabis specialist.
“The ECS performs a crucial feedback function in the ovaries, frequently resulting in lower levels of hormones like luteinizing hormone, and the ECS therefore ebbs and flows with the female menstrual cycle. There’s also a link between the ECS and the estrogen/hormonal system. Dr. Peterson, a scientific advisor for The Cannigma, an Israel-based organization that covers cannabis from a scientific perspective, explains that the endocannabinoids produced in the ovaries may have systemic action, altering female hormones all over the body and brain via the hypothalamus-pituitary axis.
Women’s health and gynecology
Gynica was founded in 2017 as part of Asana Bio Group, a cannabis-focused medical technology holding company that also includes Lumir Lab, the first approved facility to study cannabis’ effects on women’s health. Professor Lumir Ondrej Hanus, a world-renowned chemist and prominent player in cannabis and cannabinoid (cannabis component) research, heads the lab at the Hebrew University of Jerusalem’s Jerusalem Biotechnology Park. He was part of a team that discovered Anandamide, the first known endocannabinoid in the human brain, in 1992.
Professor Hanus and Dr. Sari Prutchi Sagiv, also of Lumir Lab and VP of R&D at Gynica, have led the development of the company’s proposed cannabinoid-based solutions for gynecological disorders. The research is supervised by Yotam Hod’s father, Professor Moshe Hod who is a world-recognized expert in the field of women’s health, the president of the European Association of Perinatal Medicine (EAPM), and a professor of obstetrics and gynecology at Tel Aviv University.
The company has demonstrated that “our combinations [of cannabis] decrease the migration and invasiveness of endometriotic cells” in numerous pre-clinical trials involving cannabinoids and endometriosis, according to Hod in an interview with NoCamels.
According to him, the investigations have also shown a decrease in COX-2, an enzyme that is mainly responsible for generating inflammation and is thought to play a key role in the onset and progression of endometriosis.
However, Hod adds that Gynica’s suppositories should decrease the intensity of pain in both dysmenorrhea and endometriosis since they “show a reduction in COx-2, which generates prostaglandins and is responsible for painful uterine contractility.” COX-2 promotes the development of human endometrial tissue in endometriosis.”
According to Dr. Peterson, “cannabinoids have a well-established function in triggering apoptosis (programmed cell death),” which may be helpful in situations like endometriosis or other proliferative disorders like cancer.
Following a NIS 5,000,000 ($1.55 million) investment (and a 20% interest) in late June by Tikun Olam-Cannbit, a prominent Israeli medical cannabis business established in 2019 with the purchase of Tikun Olam by Cannbit Pharmaceuticals, Gynica is currently preparing for two major milestones.
The first is a collaborative clinical trial scheduled for early 2022, which will examine the impact of Gynica’s planned cannabis-based vaginal suppositories on individuals with dysmenorrhea. According to Hod, the second step is to set up a specialized manufacturing line for the suppositories, which will use raw medical cannabis materials with IMC-GMP certification, and will be followed by other items such as cannabis-based lubricants to assist with painful intercourse, or dyspareunia.
Professor Hod said in a statement announcing the investment two months ago that the partnership with Tikun Olam-Cannbit “is an important milestone in improving the quality of life of hundreds of thousands of women in Israel and millions of women worldwide who have not received a safe and proper solution for the variety of problems and symptoms they experience daily.”
Gynica was “one of the first companies in the world to conduct clinical research on a cannabis-based vaginal product,” according to Avinoam Sapir, CEO of Tikun Olam-Cannbit, with “very strong market potential,” especially in countries like Canada, Australia, and the United Kingdom, “which have a growing demand for these products and regulation that makes it possible.”
Gynica is fortunate to “have the regulatory framework in place to run the clinical research,” according to Hod. As a company licensed by the Israeli Health Ministry to develop cannabis-based products for the female body, Gynica is fortunate to “have the regulatory framework in place to run the clinical research.”
He tells NoCamels that a lot of effort went into the various cannabis formulations as well as delivery, and that Gynica’s aim was to create a uniform, standardized vaginal suppository for a focused local approach with a slow-release mechanism.
The suppositories, according to Dr. Peterson, “make sense.”
“CB1 and CB2 [receptors] are found throughout the reproductive tract. It’s also densely packed with nerves, which express a large number of CB receptors. There are many reasons why a topical/local application may be beneficial. He adds that this delivery method may assist distribute cannabis to specific tissues without causing systemic exposure.
The Gynica and Lumir Lab researchers will test two suppository formulations, one of which will include THC, cannabis’ primary psychoactive component. However, Hod claims that there will be no psychoactive impact or systemic absorption, just medicinal advantages.
More research is required, according to Dr. Peterson, since it is “unknown how much system absorption of THC and other cannabinoids happens via the vagina (or rectum for that matter).”
Gynica’s suppositories are also being tested in a clinical study with individuals who have endometriosis, although this research is currently in the pre-clinical stage.
Hod adds, “We think we have extremely promising options [to cure endometriosis], and there is a focus on it in the pipeline.”
This article broadly covered the following related topics:
- obgyn schooling
- what is a obgyn do
- what does obgyn stand for in slang
- obstetrician schooling and salary
- ob gyn definition