-- Clinical trials, a part of research study, are conducted by running supervised tests. The main aim of these trials is to bring about an overall improvement in patient care and health. The trials help to determine effectiveness and safety of novel medical procedures, devices and drugs. They also give an understanding of risks and side-effects associated with the product being tested. While certain side-effects are mild and harmless (e.g. headache), others could be life-threatening. Hence, their analysis is extremely essential.
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Clinical trials are often divided into phases with each phase serving a distinct objective. The first phase generally assesses safety, identifies a harmless dosage range, and evaluates possible side effects on a small number of patients. Once this is declared successful, the second phase is initiated. In this phase, the trial’s safety and effectiveness is further analyzed by repeating it with a bigger patient pool. In the third phase, the patient group is expanded even more and results are compared with the best treatment in existence. The fourth phase often examines risks and side-effects in the long run.
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Dysmenorrhea, when translated literally, means ‘difficult monthly flow’. It is a medical term to describe pain during menstruation. While most women experience mild abdominal cramps on the first or second day of their period, a few may go through severe pain. Dysmenorrhea is of two types – primary and secondary. While primary dysmenorrhea is a normal phenomenon, secondary dysmenorrheal is indicative of a disorder in a woman’s reproductive organs.
Commonly prescribed treatments for primary dysmenorrhea include administration of analgesics, hormone medications, oral contraceptives, etc. Another important treatment type is transcutaneous electric nerve stimulation (TENS). Secondary dysmenorrheal necessitates diagnosis and treatment of the underlying cause.
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The market for dysmenorrhea global clinical trials is categorized into the following regional segments – Asia Pacific, North America, Europe, Middle East and Africa, and Central and South America. Some drugs currently under trial for dysmenorrhea are meloxicam, potassium diclofenac, microgestin 1/20, Shandong Danshen-Jiang-Fu Granule, Ibuprofen, Mirena, etc. It has been observed that OBE002 – the first orally active prostaglandin F2a antagonist doesn’t result in side effects associated with NSAID (nonsteroidal anti-inflammatory drug) treatment of preterm labor.
Hadasaah Medical Organization, Laboratorios Andromaco S.A., Bayer, Chengdu University of Traditional Chinese Medicine, Huazhong University of Science and Technology, and Nobelpharma are a few trial sponsors in this field.
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