Endometritis

Medicines360 and DKT WomanCare are joining forces to increase availability and use of AVIBELA, an affordable, effective, long-acting hormonal IUD developed by Medicines360, across Africa, South and Southeast Asia, Central America, and the Caribbean.SAN FRANCISCO and PARIS, Jan. 31, 2024 (GLOBE NEWSWIRE) -- Medicines360, a global nonprofit pharmaceutical organization specializing in women’s health, and DKT WomanCare, a global marketing and distribution organization focused on increasing the availability and use of high-quality contraceptive and reproductive health products, have entered into a partnership to expand access to AVIBELA, an affordable, quality-assured, long-acting hormonal IUD that is more than 99% effective at preventing pregnancy.1 This important collaboration will help more women learn about, access, and use this highly effective, modern form of contraception. The 52 mg levonorgestrel-releasing intrauterine system (“hormonal IUD”) has been largely inaccessible in lower- and middle-income countries (LMICs) due to factors limiting availability and affordability. An estimated 218 million women in LMICs have an unmet need for modern contraception, resulting in approximately 111 million unintended pregnancies (nearly 1 in 2) each year. 2 With this strategic partnership, more women around the world will have the ability to choose from a broader mix of safe, effective, and affordable contraceptive methods, including AVIBELA. "As a global nonprofit pharmaceutical organization dedicated to expanding access to affordable reproductive health products for women, DKT WomanCare is an ideal partner for our organization," said Dr. Andrea Olariu, CEO of Medicines360. “With their proven track record of building markets for new high-quality contraceptives, DKT WomanCare will help us provide more women across the world with the contraceptive options they want and deserve. Together, we will make meaningful improvements in access to build a brighter future for women.” Leveraging their global marketing expertise and reach, DKT WomanCare will increase awareness of AVIBELA, build markets, and ensure broader access across the public and private sectors in Africa, South and Southeast Asia, Central America, and the Caribbean. DKT WomanCare will draw on the experience of its parent company, DKT International, to leverage the organization’s extensive network of national and regional offices alongside DKT WomanCare’s established partnerships with ministries of health, global procurement agencies, social marketing organizations, and commercial distributors. Lauren Archer, DKT WomanCare’s Managing Director, celebrated the partnership. “DKT WomanCare looks forward to leveraging our global partnerships and commercial relationships to ensure every woman, regardless of income, can access affordable, high-quality contraception. We look forward to working with Medicines360 to achieve these goals.” “This partnership is a wonderful opportunity to educate users and practitioners about the benefits of hormonal IUDs, expanding long-term contraceptive options to women everywhere with quality products like AVIBELA,” said Chris Purdy, President of DKT International. As the supplier of AVIBELA, Medicines360 will focus on providing quality assurance and regulatory oversight, as well as ensuring sustainable product supply to DKT WomanCare and global procurement agencies. Together, Medicines360 and DKT WomanCare will meet the growing demand for quality-assured, affordable hormonal IUDs and help build a robust and sustainable global contraceptive market. AVIBELA is a trademark of Medicines360 in countries across Africa, South and Southeast Asia, Central America, and the Caribbean. For more information about AVIBELA, please visit www.avibela.com. AVIBELA™ Important Safety Information Who is not appropriate for AVIBELAContraindications to use of AVIBELA include: pregnancy; use for post-coital contraception (emergency contraception); acute pelvic inflammatory disease (PID) or endometritis or a history of PID unless there has been a subsequent intrauterine pregnancy; infected abortion in the past 3 months; known or suspected uterine or cervical neoplasia; acute liver disease or liver tumor (benign or malignant); conditions associated with increased susceptibility to pelvic infections; congenital or acquired uterine anomaly, including fibroids, that distorts the uterine cavity and would be incompatible with correct intrauterine system (IUS) placement; uterine bleeding of unknown etiology; untreated acute cervicitis or vaginitis, including bacterial vaginosis, known chlamydial or gonococcal cervical infection, or other lower genital tract infections until infection is controlled; known or suspected breast cancer or other hormone-sensitive cancer, now or in the past; a previously inserted IUS that has not been removed; a history of hypersensitivity reaction to any component of AVIBELA (reactions may include rash, urticaria, and angioedema). Clinical considerations for use of AVIBELAUse AVIBELA with caution after careful assessment in patients with coagulopathy or who are taking anticoagulants; migraine, focal migraine with asymmetrical visual loss, or other symptoms indicating transient cerebral ischemia; exceptionally severe or frequent headache; marked increase of blood pressure; or severe arterial disease such as stroke or myocardial infarction. Consider removal of the IUS if any of these conditions arise during use. Also consider removing AVIBELA if uterine or cervical malignancy, or jaundice arise during use. IUSs have been associated with an increased risk of PID, most likely due to organisms being introduced into the uterus during insertion. About 1/3 of women diagnosed with PID developed the infection within a week of AVIBELA insertion, while the remainder were diagnosed more than six months after insertion. PID is often associated with sexually transmitted infection (STI), and AVIBELA does not protect against STIs. PID or endometritis may be asymptomatic but still result in tubal damage and its sequelae. Pregnancy related risks with AVIBELAIn the case of pregnancy with AVIBELA in place, advise the woman of the increased risks for pregnancy complications, including miscarriage, premature delivery, infection and sepsis. Ectopic pregnancy should be excluded, and removal of the system should be considered. Removal of AVIBELA or probing of the uterus may result in spontaneous abortion. When a woman becomes pregnant with AVIBELA in place, the relative likelihood of ectopic pregnancy is increased. Ectopic pregnancy may require surgery and may result in loss of fertility. Women with a previous history of ectopic pregnancy, tubal surgery, or pelvic infection have a higher risk of ectopic pregnancy. Be aware of other serious complications and most common adverse reactionsSome serious complications with IUSs like AVIBELA are sepsis, perforation, and expulsion. Severe infection or sepsis, including Group A streptococcal sepsis (GAS), have been reported following insertion of other LNG-releasing IUSs. Aseptic technique during insertion of AVIBELA is essential in order to minimize serious infections such as GAS. Perforation (total or partial, including penetration/embedment of AVIBELA in the uterine wall or cervix) may occur, most often during insertion, although the perforation may not be detected until sometime later. Perforation may reduce contraceptive efficacy and result in pregnancy. If perforation is suspected, the IUS should be removed as soon as possible. Delayed detection or removal of AVIBELA in case of perforation may result in migration outside the uterine cavity, adhesions, peritonitis, intestinal perforations, intestinal obstruction, abscesses, and erosion of adjacent viscera. Partial or complete expulsion of AVIBELA may occur, resulting in the loss of contraceptive protection. Ovarian cysts may occur and are generally asymptomatic but may be accompanied by pelvic pain or dyspareunia. Evaluate persistent ovarian cysts. In a large clinical trial of 1,751 women using AVIBELA for contraception, very common undesirable effects (occurring in more than 10% of users) include procedural bleeding, vaginal bacterial infections, vulvovaginal mycotic infections, nausea or vomiting, and acne. About Medicines360Located in San Francisco, California, Medicines360 is a nonprofit global women’s health pharmaceutical organization with a mission to accelerate the timeline from health innovation to access for all women. Medicines360 is committed to working with healthcare providers, advocacy groups, and patients to deliver innovative and meaningful treatments that help women around the world have greater access to the medicines they need. For more information, visit www.medicines360.org. About DKT WomanCare Together, non-profits DKT WomanCare and DKT International are among the largest providers of reproductive health products, services, and technology in the world. Operating in more than 100 countries, they leverage principles of social entrepreneurialism and focus on ensuring wide access and availability of products, building up the capacity of health providers, and empowering consumers. For more information, see www.dktinternational.org and www.dktwomancare.org. Contacts:Heidi GlasserDirector of Marketing and Communications, Medicines360hglasser@medicines360.org Lauren ArcherManaging Director, DKT WomanCarelauren@dktwomancare.org References: Avibela (levonorgestrel-releasing intrauterine system) 52 mg [Summary of Product Characteristics and Prescribing Information]. Impact RH360; 2022.Sully EA et al., Adding It Up: Investing in Sexual and Reproductive Health 2019, New York: Guttmacher Institute, 2020, https://www.guttmacher.org/fact-sheet/investing-sexual-and-reproductive-health-low-and-middle-income-countries

Scientists have developed a synthetic extracellular matrix (ECM) that can support the growth of a mini endometrium in a dish for at least two weeks. The endometrium -- the mucosal lining of the uterus -- has been historically hard to model in the lab, which has limited scientists' ability to study its role in healthy and diseased states like endometriosis. The matrix allows cells to interact in an environment that recapitulates human physiology which could help researchers better simulate the healthy and pathological response to menstrual cycles. Scientists have developed a synthetic extracellular matrix (ECM) that can support the growth of a mini endometrium in a dish for at least two weeks. The endometrium -- the mucosal lining of the uterus -- has been historically hard to model in the lab, which has limited scientists' ability to study its role in healthy and diseased states like endometriosis. The matrix, described on August 11 in the journal Med, allows cells to interact in an environment that recapitulates human physiology which could help researchers better simulate the healthy and pathological response to menstrual cycles. "With this matrix, we can begin to extrapolate and utilize samples from patients that have been diagnosed with certain reproductive diseases," says first author Juan Gnecco of Tufts University. "We can begin to explore how organoids grown from patients' cells are behaving differently than those of healthy individuals." Until now, scientists have been growing organoids -- mini organs in a petri dish -- with a type of naturally derived hydrogel called Matrigel. Despite allowing a certain degree of support to organoid growth, Matrigel also contains proteins that can interfere with cell-cell communication. This is particularly important when modeling the endometrium, as it is composed mainly of epithelial glands and stromal cells, and their crosstalk affects how the endometrial tissue changes throughout the menstrual cycle under the influence of sex hormones. "If the stromal cells try to talk to the epithelial cell, it's like trying to talk to your friend if you're standing on the runway at the airport at rush hour," says senior author Linda Griffith  of the Massachusetts Institute of Technology about endometrium organoids co-cultured with stroma in Matrigel. Griffith, Gnecco, and their team designed a synthetic ECM using hydrogel and a minimal set of biological signals. Then they cultured endometrial stromal and epithelial organoids from human donors together in the synthetic matrix, and the co-culture remained intact over the experiment period of at least 15 days. In contrast, Matrigel did not support stromal cultures and had partly disintegrated and shrunken by day 15. The design of the synthetic ECM also allows cells to sequester their own matrix as they grow. "One of the things that can be different between a disease and a normal cell is that they may make slightly different sets of matrix molecules," says Griffith. "With this ECM, we can create a microenvironment similar to what the cells are experiencing in vivo. That's something we're very excited about." To test if the matrix could support the growth and functioning of endometrial epithelial and stromal cells, researchers treated the co-cultures with a synthetic progesterone, a sex hormone that plays a key role in the menstrual cycle, to mimic the conditions of part of the menstrual cycle. The hormone caused the epithelial layer of the organoids to become thicker, increased the secretion of a pro-gestational protein, and induced stromal differentiation, the same changes also observed in humans. The team then exposed the cultures with a type of pro-inflammatory cytokines linked to endometrial diseases in humans including endometriosis, a condition characterized by endometrial tissues growing outside of the uterus. They saw that in co-cultures that contained both epithelial and stromal cells, the cytokine greatly increased epithelial cell proliferation, a characteristic observed in people with endometriosis. The abnormal growth was not observed in mono-culture that contained only epithelial cells. "It really highlights that cell communication is important, not only for sex hormone signaling but even inflammatory communication between cells," says Gnecco. "There's still more about the mechanism that we need to delve into, and now there is a platform that can be used to investigate that in more detail. There's going to be a huge benefit for other studies downstream from this."

New Indication Expected to Increase Treatment Options of Heavy Menstrual Bleeding for up to five years in patients who choose intrauterine contraception as their method of contraception SAN FRANCISCO, July 10, 2023 /PRNewswire/ – Medicines360, a global nonprofit organization with a mission to catalyze equitable access to quality medicines for women, announced today that the U.S. Food and Drug Administration (FDA) has approved its supplemental New Drug Application (sNDA) for LILETTA® (levonorgestrel-releasing intrauterine system) 52 mg for treatment of Heavy Menstrual Bleeding (HMB) for up to five years in patients who choose intrauterine contraception as their method of contraception. A substantial body of literature has demonstrated the levonorgestrel 52 mg IUS to be highly effective at reducing bleeding in patients with HMB. "For those experiencing HMB, medical treatments are preferred over surgical treatment as they are more convenient and pose less risk," said Andrea Olariu, M.D., PhD, and CEO of Medicines360. "With limited choices of hormonal IUDs to treat HMB, we are pleased to deliver on our mission by working to offer prescribers and patients another medical treatment option." The FDA's approval of the new indication is based on efficacy and safety data from a Phase 3 clinical trial conducted by Medicines360, which was first published in Obstetrics and Gynecology in May 2023. The clinical trial included study participants of various ages, races, parity, and body mass index (BMI). LILETTA is commercially available in the U.S. through Medicines360's nonprofit pharmaceutical model. LILETTA is available at a lower cost to public health clinics enrolled in the 340B Drug Pricing Program. ABOUT LILETTA INDICATIONS LILETTA® (levonorgestrel-releasing intrauterine system) 52 mg is a hormone-releasing system placed in your uterus to prevent pregnancy for as long as you want for up to 8 years. LILETTA also treats heavy periods for up to 5 years in women who choose to use birth control placed in the uterus. IMPORTANT RISK INFORMATION Do not use LILETTA if you: Are or might be pregnant; LILETTA cannot be used as an emergency contraceptive Have a serious pelvic infection called pelvic inflammatory disease (PID); PID occurs in less than 1% of users Have an untreated lower genital infection now Have had a serious pelvic infection after an abortion or pregnancy within the last 3 months Can get infections easily; for example, if you: Have problems with your immune system Have multiple sexual partners or your partner has multiple sexual partners Have a history of PID Have or suspect you might have cancer of the uterus or cervix Have bleeding from the vagina that has not been explained Have short-term (acute) liver disease or liver tumor Have breast cancer or any other cancer that is sensitive to progestin (a female hormone), now or in the past Have an intrauterine contraceptive system (IUS) in your uterus already Have a condition of the uterus that changes the shape of the uterine cavity, such as large fibroid tumors Are allergic to levonorgestrel, silicone, polyethylene, or barium sulfate Call your healthcare provider right away if you think you are pregnant. If you get pregnant while using LILETTA, you may have an ectopic pregnancy, which means the pregnancy is not in the uterus. Unusual vaginal bleeding or abdominal pain, especially with missed periods, may be a sign of ectopic pregnancy. Ectopic pregnancy can cause internal bleeding. There are also risks if you get pregnant while using LILETTA and the pregnancy is in the uterus. Severe infection and premature labor or delivery can occur with pregnancies that continue with an IUS Although uncommon, pregnancy while using LILETTA can be life-threatening and may result in loss of pregnancy or fertility Life-threatening infection can occur within the first few days after LILETTA is placed. Call your healthcare provider immediately if you develop severe pain or fever shortly after LILETTA is placed Some IUS users get a serious pelvic infection called pelvic inflammatory disease (PID) or endometritis. These may be sexually transmitted. You have a higher chance of getting PID or endometritis if you or your partner has sex with other partners. PID or endometritis can cause serious problems such as infertility, ectopic pregnancy, or pelvic pain that does not go away. More serious cases of PID or endometritis may require surgery. Removal of the uterus (hysterectomy) is sometimes needed. In rare cases, infections that start as PID or endometritis can even cause death. Tell your healthcare provider right away if you have any of these signs of PID or endometritis: long-lasting or heavy bleeding, unusual or foul-smelling vaginal discharge, low abdominal or pelvic pain, painful sex, genital lesions or sores, chills, or fever LILETTA may partially go into (become embedded) or go completely through (perforate) the wall of the uterus. If perforation occurs, LILETTA may move outside thevuterus and can cause internal scarring, infection, or damage to other organs. You may need surgery to have LILETTA removed if it is embedded, or perforation occurs. Risk of perforation is increased in breastfeeding women LILETTA may come out of your uterus (expulsion). Expulsion occurs in about 4 out of 100 women, most often in the first year of use. You may become pregnant if LILETTA comes out. If you think that LILETTA has come out, use another birth control method like condoms or do not have sex (vaginal intercourse) until you are seen by a healthcare provider Ovarian cysts may occur but usually disappear Bleeding and spotting may increase in the first 3 to 6 months and remain irregular. Periods over time usually become shorter, lighter, or may stop LILETTA does not protect against HIV or STDs. Available by prescription only. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. Please see full Prescribing Information for LILETTA. About Medicines360 Medicines360, located in San Francisco, California, is a global nonprofit women's health pharmaceutical organization with a mission to catalyze equitable access to medicines and devices through product development, policy advocacy, and collaboration with US and global partners. For more information, visit SOURCE Medicines360