A Prospective, Single-Arm, Open-Label Study to Determine the Safety and Effectiveness of ANAFORTAN-MFÂ® Tablets (Fixed Dose Combination of CamylofinDihydrochloride 50 mg plus Mefenamic Acid I.P. 250 mg) in Primary Dysmenorrhea in India.

MS Accent Pharma0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1. Women >=18 years of age with a history of moderate to severe primary dysmenorrhea during four or more of the previous six menstrual cycles
•2. Women presenting with dysmenorrhea on the 1st or 2nd day of their current menstrual cycle
•3. Women willing and able to provide written informed consent by signing the informed consent form (ICF)

•1. Women with a history of taking Anafortan-MFÂ® or any other prescription-only and/or nonprescription analgesics, antispasmodics, antidepressants, or antipsychotic medication (within the previous 4 weeks before study enrolment)
•2. Pregnant or Lactating women
•3. Women with organic dysmenorrhea (including the following etiologies: leiomyomata [fibroids], pelvic inflammatory disease, tubo-ovarian abscess, ovarian torsion, endometriosis)
•4. Women using an intrauterine contraceptive device (IUCD)
•5. Cognitive impairment, alcohol abuse, or psychiatric illness that would affect the ability of the patient to complete patient diary and other assessments
•6. History of hypersensitivity to study drug (Anafortan-MFÂ®)
•7. Women who are allergic to (Anafortan-MFÂ®) or any of the study drug ingredients, have undergone coronary artery bypass graft surgery, epilepsy, hypersensitivity, and/or inflammatory bowel disease
•8. Any other illness or conditions that does not justify the womanâ??s participation in the study as judged by the Investigator
•9. Woman not willing to comply with the study procedures

发起方

MS Accent Pharma