Safety and Efficacy Evaluation of Topical Pain Relief Patches in Indian Females with Primary Dysmenorrhea

ITC Life Sciences and Technology Centre0 个研究点目标入组 79 人开始时间: 待定最近更新: 2022年10月17日

试验速览

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•1)Suggestion: Stage I: 19 to 35 yrs (both inclusive) Stage II: 15 to 18yrs (both inclusive)
•2)Subject has a history of regular menstrual cycles that typically occurs between every 21 to 35 days;
•3)Subject has a self-reported history of primary dysmenorrhea;
•4)Subject has a history of OTC analgesic use for treatment of primary dysmenorrhea;
•5)Subject is not pregnant on the day of screening and agrees to use the suggested methods of contraception for the duration of the study:
•oSexual Abstinence from the last menstrual cycle or willingness to use double barrier method of protection;
•oOral contraceptive.
•6)Subject is 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)Subject is willing to abide by the study restrictions and protocol;
•8)Subject is willing to use the test product as per the instructions during the study and return to the study site at the defined period.

•1)Subject has a current or past history of one or more of the following conditions: secondary dysmenorrhea, mild dysmenorrhea, pelvic inflammatory disease, urinary tract infection, adnexal masses, uterine fibroids, endometriosis, adenomyosis that in the opinion of the Investigator could impact Subject safety and/or the study data;
•2)Subject has a known history of allergic, idiosyncratic or serious adverse reaction, to occlusive adhesive tapes / patches;
•3)Subject has significant co-existing illness, including gastrointestinal, hepatic, renal, neurologic, cardiovascular, psychiatric, endocrine, respiratory, surgical procedure or other condition that, in the InvestigatorÃ¢â?¬•s judgment, contraindicates administration of the study product / interferes with the study results;
•4)Subject has a current / past history of severe gastritis, gastrointestinal bleeding or ulceration;
•5)Subject has an ongoing sexually transmitted disease (except for a history of genital herpes or Human Papillomavirus) or has abnormal vaginal discharge;
•6)Pregnant (Negative UPT) or lactating (Self declaration) or less than 6 months post-partum (Self declaration).
•7)Participation in a clinical study or any patch studies within the previous 30 days.
•8)Subjects on any prescription medicines that might interfere with the study outcome.
•9)Current skin disorders/open wounds in the area to be treated.
•10)Any patient, in the investigators opinion not considered suitable for enrolment.

发起方

ITC Life Sciences and Technology Centre