CTRI/2022/06/043372已完成未知
A Randomized, Double-Blind, Placebo-Controlled, Safety and Efficacy Evaluation of Period Pain Relief Patches in females with Primary Dysmenorrhea
nexo Life Sciences Pvt Ltd0 个研究点目标入组 78 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 78
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1) Age: 19-35 years (both inclusive) healthy, adult females in group I & 15-18 years (both inclusive) healthy adolescent females in group II at the time of assent.
- •2) History of regular menstrual cycles that typically occurs between every 21 to 35 days.
- •3) Self-reported history of primary dysmenorrhea (onset <5 years after menarche) with at least moderate / severe menstrual cramp pain (based on the categorical pain intensity scale) / a pain score of >5 on the Numeric Analog Scale occurring during at least 4 of the past 6 menstrual cycles.
- •4) History of OTC analgesic use (Naproxen/ Aspirin/ Acetaminophen/ Ibuprofen) for treatment of primary dysmenorrhea as taken at least 1 day of her menstrual cycle and normally experiences pain relief from these medications.
- •5) Not pregnant on the day of screening and agrees to use contraception for the duration of the study.
- •6) Willing to participate in the study, give a signed consent OR an assent and consent of the respective Legal guardian in case of adolescent females.
- •7) Willing to abstain from alcohol and caffeine consumption throughout the 12-hour Treatment Period.
- •8) Willing to use the test product as per the instructions during the study and return to the study site within approximately 12hr of removing the patch for review along with the completed Subject diary.
排除标准
- •1) Current or past history of one or more of the following conditions: secondary dysmenorrhea, mild dysmenorrhea, pelvic inflammatory disease, urinary tract infection (acute or recurrent), adnexal masses, uterine fibroids, endometriosis, adenomyosis that in the opinion of the Investigator could impact Subject safety and/or the study data.
- •2) Known history of allergic, idiosyncratic or serious adverse reaction, to occlusive adhesive tapes / patches.
- •3) With significant co-existing illness, including gastrointestinal, hepatic, renal, neurologic, cardiovascular, psychiatric, endocrine, respiratory, surgical procedure or other condition that, in the Investigatorâ??s judgment, contraindicates administration of the study product / interferes with the study results.
- •4) Current / past history of severe gastritis, gastrointestinal bleeding or ulceration.
- •5) Having an ongoing sexually transmitted disease (except for a history of genital herpes or Human Papillomavirus) or has abnormal vaginal discharge.
- •6) Pregnant (Positive UPT) or lactating (Self declaration) or is less than 6 months post-partum (Self declaration).
- •7) Having menstrual cramp pain during night-time. (This Criteria will be verified at the time of Visit-02).
- •8) Have undergone any relevant surgical treatment during the previous two months or planned during the study.
- •9) On any prescription medicines that might interfere with the study outcome.
- •10) With current skin disorders/open wounds in the area to be treated.
- •11) With history of drug and alcohol abuse.
研究者
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