None listed
Conditions
Interventions
Intervention1: Period Pain Relief Patch: One patch to be applied at the site of pain (lower abdomen/ lower back) for at least 12 hours.
Control Intervention1: Placebo Patch: One patch to be applied at
Sponsors
Unexo Life Sciences Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To study the Safety and Efficacy of Topical Pain relief Patches on Menstrual painsTimepoint: Visit 02, Visit 03, Visit 04 | — |
Secondary
| Measure | Time frame |
|---|---|
| NATimepoint: NA | — |
Countries
India
Contacts
Public ContactDr Simran Sethi
Cliantha Research
Outcome results
None listed