None listed
Conditions
Interventions
Intervention1: TDP2: One patch to be applied at the site of pain (lower abdomen/ lower back) for at least 12 hours
Control Intervention1: TDP1: One patch to be applied at the site of pain (lower abdom
Sponsors
ITC Life Sciences and Technology Centre
Eligibility
Inclusion criteria
Inclusion criteria: 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: o Sexual Abstinence from the last menstrual cycle or willingness to use double barrier method of protection; o Oral 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.
Exclusion criteria
Exclusion criteria: 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 Investigatorââ?¬•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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To study the Safety and Analgesic efficacy of Topical Pain relief Patches on Menstrual painsTimepoint: Baseline, onset of pain, every 2 hrs for 12 hrs. | — |
Secondary
| Measure | Time frame |
|---|---|
| Not ApplicableTimepoint: Not Applicable | — |
Countries
India
Contacts
Public ContactMs Maheshvari Patel
Cliantha Research
Outcome results
None listed