A Prospective, Single-Arm, Open-Label Study to Determine the Safety and Effectiveness of ANAFORTAN-MF® Tablets (Fixed Dose Combination of CamylofinDihydrochloride 50 mg plus Mefenamic Acid I.P. 250 mg) in Primary Dysmenorrhea in India.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 274
- 试验地点
- 5
- 主要终点
- To assess the safety of Anafortan-MF® in women with primary dysmenorrhea
研究概览
简要总结
Purpose:
Primary dysmenorrhea is one of the most frequent gynecological disorders affecting more than half of post-pubescent women. It interferes with daily activities, which affects women’s quality of life. The mainstay of treatment of primary dysmenorrhea includes various classes of NSAIDs, antispasmodics, and hormonal therapies. A combination of camylofin and mefenamic acid may provide better symptomatic relief by alleviating spasm and pain. However, there is a paucity of data on the safety and effectiveness of camylofin and mefenamic acid combination in a real-world setting for the treatment of pain associated with primary dysmenorrhea in women in the Indian population. In the present study, we aim to assess the safety and effectiveness of Anafortan-MF® (fixed-dose combination [FDC]) of camylofin 50 mg and mefenamic acid 250 mg) for the treatment of primary dysmenorrhea in Indian women.ial
Croissance Clinical Research is supporting to the end to end activities for this trials.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- Female
入选标准
- •Women ≥18 years of age with a history of moderate to severe primary dysmenorrhea during four or more of the previous six menstrual cycles
- •Women presenting with dysmenorrhea on the 1st or 2nd day of their current menstrual cycle
- •Women willing and able to provide written informed consent by signing the informed consent form (ICF).
排除标准
- •Women with a history of taking Anafortan-MF® or any other prescription-only and/or nonprescription analgesics, antispasmodics, antidepressants, or antipsychotic medication (within the previous 4 weeks before study enrolment)
- •Pregnant or Lactating women
- •Women with organic dysmenorrhea (including the following etiologies: leiomyomata [fibroids], pelvic inflammatory disease, tubo-ovarian abscess, ovarian torsion, endometriosis)
- •Women using an intrauterine contraceptive device (IUCD)
- •Cognitive impairment, alcohol abuse, or psychiatric illness that would affect the ability of the patient to complete patient diary and other assessments
- •History of hypersensitivity to study drug (Anafortan-MF®)
- •Women who are allergic to (Anafortan-MF®) or any of the study drug ingredients, have undergone coronary artery bypass graft surgery, epilepsy, hypersensitivity, and/or inflammatory bowel disease
- •Any other illness or conditions that does not justify the woman’s participation in the study as judged by the Investigator
- •Woman not willing to comply with the study procedures.
结局指标
主要结局
To assess the safety of Anafortan-MF® in women with primary dysmenorrhea
时间窗: 4 days or 6 Days (Depends on physician discretion)
次要结局
- To determine the effect of Anafortan-MF® on pain intensity through VAS scale for the treatment of women with primary dysmenorrhea To determine the effect of Anafortan-MF® on the frequency of daily pain episodes over a 3-day or 5-day course of treatment (as per physician’s discretion(4 days or 6 days (Depends on physician discretion))