The purpose of this study is to further assess the efficacy, safety and dose-response of KYG0395 in the treatment of primary dysmenorrhea.
Compare the effect and safety of the investigational drug and placebo on dysmenorrhea in adult otherwise healthy women.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
280
3 KYG0395 capsules tid (morning, midday, and evening)
3 KYG0395 capsules 2 times a day (bid) (morning and evening) plus 3 capsules of placebo (midday)
3 capsules of placebo tid (morning, midday, and evening)
Women's Health Research
Phoenix, Arizona, United States
The Change From Baseline to the End of Treatment Period in Maximum Dysmenorrheic Pain VAS Score
VAS is represented by a straight line with extreme limits: from "no pain" and an associated image of a happy face at the left endpoint to "unbearable pain" and an associated image of an unhappy face at the right endpoint. The left endpoint is the minimum pain score of zero while the right endpoint is the maximum pain score of 100. The dysmenorrheic pain (lower abdominal cramping pain) that usually occurs just before and/or during menstruation was measured in this study using a The Visual Analogue Scale (VAS). Pain was assessed during 9 menstrual cycles from the beginning of the screening to the end of follow-up.
Time frame: Baseline and end of treatment (6 months)
The Change From Baseline in Number of Days With Dysmenorrheic Pain at the End of Treatment
The change from baseline in number of days with dysmenorrheic pain at the end of 3 treatment cycles
Time frame: Baseline and end of treatment (6 months)
The Change From Baseline to the End of Follow-up Period in the Maximum VAS Score
VAS is represented by a straight line with extreme limits: from "no pain" and an associated image of a happy face at the left endpoint to "unbearable pain" and an associated image of an unhappy face at the right endpoint. The left endpoint is the minimum pain score of zero while the right endpoint is the maximum pain score of 100. The dysmenorrheic pain (lower abdominal cramping pain) that usually occurs just before and/or during menstruation was measured in this study using a The Visual Analogue Scale (VAS). Pain was assessed during 9 menstrual cycles from the beginning of the screening to the end of follow-up.
Time frame: Baseline and end of follow-up (9 months)
The Number of Days of Dysmenorrheic Pain at the End of Follow-up Period Compared With Baseline
The change from baseline in the number of days with dysmenorrheic pain at the end of a 3-cycle follow-up period
Time frame: Baseline and end of follow-up (9 months)
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Lynn Institute of the Ozarks
Little Rock, Arkansas, United States
Women's Health Care at Frost Street
San Diego, California, United States
Coastal Connecticut Research
New London, Connecticut, United States
Atlanta Women's Research Institute, Inc.
Atlanta, Georgia, United States
Women's Healthcare Associates dba Rosemark WomenCare Specialists
Idaho Falls, Idaho, United States
Chicago Research Center, Inc.
Chicago, Illinois, United States
Genesis Clinical Research
Fall River, Massachusetts, United States
ClinSite
Ann Arbor, Michigan, United States
Montana Medical Research
Missoula, Montana, United States
...and 13 more locations
Average Daily Dysmenorrheic Pain VAS Score at the End of Treatment and Follow-up Period
VAS is represented by a straight line with extreme limits: from "no pain" and an associated image of a happy face at the left endpoint to "unbearable pain" and an associated image of an unhappy face at the right endpoint. The left endpoint is the minimum pain score of zero while the right endpoint is the maximum pain score of 100. The dysmenorrheic pain (lower abdominal cramping pain) that usually occurs just before and/or during menstruation was measured in this study using a The Visual Analogue Scale (VAS). Pain was assessed during 9 menstrual cycles from the beginning of the screening to the end of follow-up.
Time frame: Baseline, end of treatment (6 months) and end of follow-up (9 months)
Rescue Medication Consumption at the End of Treatment and Follow-up Period
The change from baseline to the end of treatment and follow-up period in rescue medication consumption
Time frame: Baseline, end of treatment (6 months) and end of follow-up (9 months)
Subject's Overall Satisfaction at the End of the 3-cycle Follow-up Period
The subject's evaluation of overall satisfaction was recorded in the electronic subject diary at the end of the 3 treatment cycles and at the end of the 3-cycle follow-up period (at the end of the day before the subject goes to bed) using the numeric rating scale provided below: 0=None, Not satisfied with the treatment outcome; 1. Mild, Mildly satisfied with the treatment outcome; 2. Most, Mostly satisfied with the treatment outcome; 3. Complete, Completely satisfied with the treatment outcome.
Time frame: Base line and end of follow-up (9 months)