An Open Label, Prospective, Single Arm, Non-Randomized, Multi-Centric Pilot Study to Evaluate the Efficacy and tolerability of Dysmegesic in the management of Menstrual Pain in Female Subjects.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 5
- 主要终点
- Change in VMS & NRS Scores from Baseline to end of each cycle
研究概览
简要总结
This is an open label, single arm, prospective, multi-centric clinical trial to evaluate the efficacy and tolerability of Dysmegesic, 750 mg. Female subjects aged between 16 and 30 years (both inclusive) suffering from primary dysmenorrhea (PD) of moderate to severe severity and meeting all inclusion and no exclusion criteria will be enrolled in the study after signing a written informed consent/assent form. Diagnosis was based on the subject’s history and physical examination.During the screening/enrollment, demographic details such as date of birth, education and occupation details will be obtained. Medical history, details of prior and concomitant medications will be elicited. The study procedures will be explained and instructions regarding study assessments will be provided.After passing the eligibility criteria, the subjects will be dispensed the test formulation (Dysmegesic, 750 mg) for self-administering twice a day from the start of menstrual pain for a duration of 3 days for 2 consecutive menstrual cycles. Subjects can take a maximum of 2 additional dose or 1 additional day for pain relief, in case pain persists after 3 days of Dysmegesic administration. Any rescue medication (analgesic) would be permitted after 2 hours of administration, if the test formulation would not be effective to control the symptoms. The details of extra dosing of Dysmegesic or rescue medication, will be noted in the subject dairy. A detailed clinical evaluation of dysmenorrhoea will be done. The efficacy of the test formulation will be assessed by VMS, NRS and MSQ questionnaire at the end of each cycle. The severity of dysmenorrhoea will be assessed by a Verbal Multidimensional Scoring system (VMS) and by Numeric Rating Score system for pain (NRS). Menstrual Symptom Questionnaire (MSQ) will be administered to evaluate the symptoms of dysmenorrhea. The tolerability of the test formulation will be assessed by incidence of adverse events reported.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 16.00 Year(s) 至 30.00 Year(s)（—）
- 性别
- Female
入选标准
- •Subjects with either “Moderate†or “Severe†dysmenorrhea severity assessment during Visit 1
- •Regular menstrual cycles for atleast 6 months
- •Subjects with body mass index of 18.50 to 30.00 kg/m2 (Both values inclusive)
- •Subjects who understand the nature and purpose of the study and who are willing to comply with study procedures.
- •Agrees not to participate in other clinical studies within 30 days after the last administration of the study treatment
- •Must be willing and able to give informed consent and comply with the study procedures.
排除标准
- •Known or suspected secondary dysmenorrhea (major abdominal or pelvic surgery, endometriosis, salpingitis, pelvic inflammatory disease (PID), ovarian cysts, pathological vaginal secretion, chronic abdominal pain, endometriosis, fibroids, obstructive endometrial polyps, cervical stenosis inflammatory bowel disease, irritable bowel syndrome).
- •Subjects suffering from mild primary dysmenorrhea.
- •Concomitant treatment with oral contraceptives, gonadotrophin releasing hormone agonists and antagonists, antiandrogens, gonadotropins, anti-obesity drugs.
- •Recent history of abdominal surgery in the last 6 months.
- •Unevaluated gynaecological abnormalities inclusive of oncological diagnosis or suspicion (unexplained vaginal bleeding, cervical dysplasia)
- •Gross developmental defect or congenital abnormalities of uterus
- •Subjects with uncontrolled hypertension, diabetes or other uncontrolled co-morbidities.
- •Pregnant and nursing women or women who have given birth or had a miscarriage.
- •Women who have undergone hysterectomy.
- •Any history of major systemic illness and significant gastrointestinal & liver disorders, renal disorders, endocrine abnormalities, cardiovascular, respiratory, neuropsychiatric disorders or any other significant medical illness, in view of the investigator.
- •Subjects who are contemplating surgery/ pregnancy within 90 days after scheduled end of study treatment
- •Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study
- •Any additional condition(s) that in the Investigators opinion would warrant exclusion from the study or prevent the subject from completing the study.
结局指标
主要结局
Change in VMS & NRS Scores from Baseline to end of each cycle
时间窗: Day 0, Day 28, Day 56
次要结局
- Mean change in Menstrual Symptom Questionnaire (MSQ) score(Day 0, Day 28, Day 56)
- Mean change in duration of time for pain relief(Day 0, Day 28, Day 56)
- Mean change inAbsenteeism from work or school/college, Use of any rescue medication(Day 0 Day 28, Day 56)