Study on Pain Relief Patches For Pain during Menstruatio

Not Applicable

Completed

• Registration Number: CTRI/2021/03/032272
• Lead Sponsor: ITC Life Sciences and Technology Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-07-22
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 79

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:

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.

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
ot ApplicableTimepoint: Not Applicable