Frequently Asked Questions
Period Pain
Also known as menstrual pain or its medical terminology, dysmenorrhea, is a chronic pain that occurs once a month for several days during menstruation.
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Period pain, also known as menstrual pain or by its medical terminology, dysmenorrhea, describes the painful sensations experienced by individuals during menstruation. It is a frequently occurring condition characterized by lower abdominal or pelvic pain that can range from mild discomfort to severe cramping.
Dysmenorrhea is sub-divided into two categories; primary, where pain occurs without any underlying medical condition, and secondary, resulting from an underlying condition such as endometriosis or uterine fibroids. The pain typically occurs shortly before or during menstruation and can be accompanied by other symptoms such as nausea, headache, and fatigue.
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The detailed mechanisms of dysmenorrhea are not fully understood. It is becoming apparent that abnormal production and activity of a tissue hormone called prostaglandins are at the center of the disease. For menstruating persons who experience dysmenorrhea, hormonal changes reflected by the drop in progesterone shortly before menstruation, leads to increased production of inflammatory substances, mainly prostaglandins. Prostaglandins cause the blood vessels in the uterus to constrict, resulting in reduced blood flow and tissue damage, which leads to pain. Prostaglandins also directly contribute to the signaling of pain. While factors like childbirth history, diet, and physical activity can influence the signaling of prostaglandins in the uterus and the generation of pain, the occurrence of primary dysmenorrhea is likely determined by congenital and genetic factors.
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Dysmenorrhea and pre-menstrual syndrome (PMS) are both related to the menstrual cycle but differ in timing and symptoms. Dysmenorrhea involves painful menstrual cramps occurring during menstruation and can include lower back pain, nausea, and headaches. It can be primary (natural) or secondary (caused by other medical conditions). PMS, on the other hand, manifests in the one to two weeks before menstruation and includes a range of physical, emotional, and behavioral symptoms such as mood swings, bloating, and breast tenderness. While dysmenorrhea focuses on menstrual pain, PMS involves broader pre-menstrual symptoms due to hormonal changes.
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According to the World Health Organization (WHO), approximately 10% out of 190 million women and girls of reproductive age worldwide are affected by endometriosis. Endometriosis is currently defined as a chronic condition characterized by abnormal growth of endometrial-like tissue outside the uterine cavity. This condition leads to inflammation and the formation of scar tissue primarily in the pelvic region. Due to the irritated nerves caused by the inflammation, individuals suffer from severe pain in this area. The pain experienced, especially during menstruation, significantly impacts daily activities and quality of life. While a long-term cure for endometriosis is lacking, symptom management through surgical interventions or medical treatments is common. However, these treatments either involve hormones or pain medications, which can lead to significant side effects due to the high dosage required for adequate symptom management.
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Adenomyosis is a medical condition where endometrial tissue, which normally lines the uterus, grows into the muscular wall of the uterus. This can cause symptoms such as heavy or prolonged menstrual bleeding, severe cramps, pelvic pain, and an enlarged uterus.
The Medical Landscape
How many people are affected and what solutions currently exist?
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Dysmenorrhea is a widespread condition among the general population. Several studies have recently come to light regarding the prevalence of this condition indicating that approximately one in three women are prevented from participating in daily activities due to dysmenorrhea. At the same time, only half of affected women openly admit their conditions to their families. This points to a larger issue of avoidance and repression in wider society, leading women to suffer from dysmenorrhea in silence.
Dysmenorrhea is sub-divided into two categories; primary, where pain occurs without any underlying medical condition, and secondary, resulting from an underlying condition such as endometriosis or uterine fibroids. The pain typically occurs shortly before or during menstruation and can be accompanied by other symptoms such as nausea, headache, and fatigue.
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Several treatment options exist for the treatment of dysmenorrhea. These include hormonal therapies, such as oral contraceptive pills or hormonal intrauterine devices (IUDs) which aim to regulate the menstrual cycle and thereby reduce pain. In addition, subcutaneous hormone-emitting implants and hormone-releasing vaginal rings are available.
Nonsteroidal anti-inflammatory drugs (NSAIDs) such as Ibuprofen which are available as oral medication can be used to manage pain symptoms. In more severe cases, surgical interventions such as laparoscopic excision or ablation of endometriotic lesions, may be considered.
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A conventional IUD is a small, usually T-shaped contraceptive device that is inserted into the uterus to prevent pregnancy. It is a long-term, reversible birth control method that offers effective contraception for several years. Conventional IUDs work by either releasing hormones (hormonal IUD) or by a local, inflammatory effect on the endometrium which is toxic to sperm (copper IUD). They are inserted by a healthcare professional and provide continuous contraception without requiring daily active drug intake.
Our Solution
melioOne is currently in the pre-clinical stage of development. If you’re interested, we invite you to subscribe to our newsletter to stay informed about updates and product developments.
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melioOne is our solution to long-term, localized pain management, hormone-free solution that targets the problem at its source.
Our solution is centered around an innovative polymer-based technology that enables slow and localized release directly at the site of origin. The mechanism releases sustained low dosage of pain medication to prevent and manage ongoing inflammation.
The dosage amount released in 12 months is equivalent to one Ibuprofen 400 pill and prevents side effects often associated with sustained high drug dosage consumption.
By targeting inflammation, melioOne offers a unique treatment option for individuals with endometriosis and adenomyosis. Considering the impact of menstrual symptoms on daily activities in a large group of women, it is time to open the societal dialogue and improve education for both patients and doctors.
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melioOne is suitable for menstruating people looking for a long-term pain management solution without any systemic side effects. It will be particularly suited for individuals who cannot or do not want to use hormone-based treatments as well as individuals who are suffering from dysmenorrhea and are concerned about the side-effects caused by sustained reliance on NSAIDs.
melioOne is intended to be used under the guidance and prescription of a healthcare professional. If you are experiencing severe pelvic pain and discomfort during your menstrual cycle, it is recommended to consult with your healthcare provider to determine if melioOne may be an appropriate treatment option for you. They will evaluate your condition and provide personalized advice on when and how to use melioOne for optimal symptom relief.
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Dysmenorrhea is commonly associated with endometriosis. By providing pain relief from dysmenorrhea, melioOne can help alleviate the pain and discomfort but it does not treat the underlying condition of endometriosis itself as no long-term cure for endometriosis currently exists.
It's important to understand that melioOne targets the management of dysmenorrhea symptoms and consultation with a healthcare professional is recommended to determine a suitable treatment plan for addressing endometriosis.
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melioOne differs from other intrauterine devices (IUDs) through its focus on dysmenorrhea. While traditional IUDs primarily provide contraception, melioOne is specifically designed to target and alleviate the pain and discomfort experienced during menstruation. It utilizes innovative technology and a hormone-free medication delivery system for slow and localized release, specifically addressing the inflammation and pain which characterize dysmenorrhea. By targeting this specific symptom, melioOne offers a unique treatment option for individuals with endometriosis and dysmenorrhea, aiming to improve quality of life and provide effective symptom relief.
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At the moment, we are striving to optimize the durability of the melioOne to provide effective symptom relief for a minimum of 18-24 months (about 2 years)
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At present, melioOne is designed as a non-contraceptive. In the future, we plan to develop additional products that may combine contraceptive and pain management for dysmenorrhea.
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No. Self-insertion is not advised as melioOne is a prescription-only medical device. Therefore, it should be inserted by a trained healthcare professional to ensure proper placement and to minimize risks. Please make sure to consult a qualified healthcare provider for a prescription and for advice on the safe and effective use of melioOne.
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meliodays medical owns the IP priority in 157 countries for melioOne.