Trial Outcomes & Findings for Effect of KYG0395 on Primary Dysmenorrhea (NCT NCT01588236)
NCT ID: NCT01588236
Last Updated: 2025-10-01
Results Overview
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.
COMPLETED
PHASE2
280 participants
Baseline and end of treatment (6 months)
2025-10-01
Participant Flow
Participant milestones
| Measure |
KYG0395 (High Dose Group)
KYG0395: 3 KYG0395 capsules tid (morning, midday, and evening)
|
KYG0395 (Lower Dose Group)
KYG0395: 3 KYG0395 capsules 2 times a day (bid) (morning and evening) plus 3 capsules of placebo (midday)
|
Placebo
placebo: 3 capsules of placebo tid (morning, midday, and evening)
|
|---|---|---|---|
|
Overall Study
STARTED
|
92
|
94
|
94
|
|
Overall Study
Overall Study
|
92
|
94
|
94
|
|
Overall Study
COMPLETED
|
61
|
51
|
66
|
|
Overall Study
NOT COMPLETED
|
31
|
43
|
28
|
Reasons for withdrawal
| Measure |
KYG0395 (High Dose Group)
KYG0395: 3 KYG0395 capsules tid (morning, midday, and evening)
|
KYG0395 (Lower Dose Group)
KYG0395: 3 KYG0395 capsules 2 times a day (bid) (morning and evening) plus 3 capsules of placebo (midday)
|
Placebo
placebo: 3 capsules of placebo tid (morning, midday, and evening)
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
5
|
4
|
1
|
|
Overall Study
Lost to Follow-up
|
8
|
13
|
6
|
|
Overall Study
Physician Decision
|
1
|
2
|
0
|
|
Overall Study
Protocol Violation
|
0
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
14
|
16
|
18
|
|
Overall Study
Exclusion Criteria met during study
|
2
|
1
|
0
|
|
Overall Study
sponsor decision
|
1
|
6
|
2
|
Baseline Characteristics
Effect of KYG0395 on Primary Dysmenorrhea
Baseline characteristics by cohort
| Measure |
KYG0395 (High Dose Group)
n=81 Participants
KYG0395: 3 KYG0395 capsules tid (morning, midday, and evening)
|
KYG0395 (Lower Dose Group)
n=77 Participants
KYG0395: 3 KYG0395 capsules 2 times a day (bid) (morning and evening) plus 3 capsules of placebo (midday)
|
Placebo
n=80 Participants
placebo: 3 capsules of placebo tid (morning, midday, and evening)
|
Total
n=238 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
27.8 years
STANDARD_DEVIATION 4.28 • n=5 Participants
|
26.8 years
STANDARD_DEVIATION 5.18 • n=7 Participants
|
27.3 years
STANDARD_DEVIATION 4.55 • n=5 Participants
|
27.3 years
STANDARD_DEVIATION 4.67 • n=4 Participants
|
|
Sex: Female, Male
Female
|
81 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
238 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
14 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
67 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
200 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
17 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
66 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
59 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
157 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and end of treatment (6 months)Population: Full analysis set: all subjects who received at least one treatment dose and had one post-baseline assessment
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.
Outcome measures
| Measure |
KYG0395 (High Dose Group)
n=81 Participants
KYG0395: 3 KYG0395 capsules tid (morning, midday, and evening)
|
KYG0395 (Lower Dose Group)
n=77 Participants
KYG0395: 3 KYG0395 capsules 2 times a day (bid) (morning and evening) plus 3 capsules of placebo (midday)
|
Placebo
n=80 Participants
placebo: 3 capsules of placebo tid (morning, midday, and evening)
|
|---|---|---|---|
|
The Change From Baseline to the End of Treatment Period in Maximum Dysmenorrheic Pain VAS Score
|
-19.8 units on a scale
Standard Error 2.84
|
-18.0 units on a scale
Standard Error 3.07
|
-14.4 units on a scale
Standard Error 2.86
|
PRIMARY outcome
Timeframe: Baseline and end of treatment (6 months)Population: Full analysis set: all randomized subjects who received at least 1 dose of study treatments, and had at least 1 valid postbaseline assessment of dysmenorrheic pain VAS score
The change from baseline in number of days with dysmenorrheic pain at the end of 3 treatment cycles
Outcome measures
| Measure |
KYG0395 (High Dose Group)
n=81 Participants
KYG0395: 3 KYG0395 capsules tid (morning, midday, and evening)
|
KYG0395 (Lower Dose Group)
n=77 Participants
KYG0395: 3 KYG0395 capsules 2 times a day (bid) (morning and evening) plus 3 capsules of placebo (midday)
|
Placebo
n=80 Participants
placebo: 3 capsules of placebo tid (morning, midday, and evening)
|
|---|---|---|---|
|
The Change From Baseline in Number of Days With Dysmenorrheic Pain at the End of Treatment
|
-1.4 days
Standard Error 0.17
|
-1.3 days
Standard Error 0.19
|
-1.1 days
Standard Error 0.18
|
PRIMARY outcome
Timeframe: Baseline and end of follow-up (9 months)Population: FAS: all randomized subjects who received at least 1 dose of study treatments, and had at least 1 valid postbaseline assessment of 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.
Outcome measures
| Measure |
KYG0395 (High Dose Group)
n=81 Participants
KYG0395: 3 KYG0395 capsules tid (morning, midday, and evening)
|
KYG0395 (Lower Dose Group)
n=77 Participants
KYG0395: 3 KYG0395 capsules 2 times a day (bid) (morning and evening) plus 3 capsules of placebo (midday)
|
Placebo
n=80 Participants
placebo: 3 capsules of placebo tid (morning, midday, and evening)
|
|---|---|---|---|
|
The Change From Baseline to the End of Follow-up Period in the Maximum VAS Score
|
-22.8 unit of a scale
Standard Error 2.93
|
-15.5 unit of a scale
Standard Error 3.21
|
-9.8 unit of a scale
Standard Error 2.79
|
PRIMARY outcome
Timeframe: Baseline and end of follow-up (9 months)Population: FAS: all randomized subjects who received at least 1 dose of study treatments, and had at least 1 valid postbaseline assessment of dysmenorrheic pain VAS score
The change from baseline in the number of days with dysmenorrheic pain at the end of a 3-cycle follow-up period
Outcome measures
| Measure |
KYG0395 (High Dose Group)
n=81 Participants
KYG0395: 3 KYG0395 capsules tid (morning, midday, and evening)
|
KYG0395 (Lower Dose Group)
n=77 Participants
KYG0395: 3 KYG0395 capsules 2 times a day (bid) (morning and evening) plus 3 capsules of placebo (midday)
|
Placebo
n=80 Participants
placebo: 3 capsules of placebo tid (morning, midday, and evening)
|
|---|---|---|---|
|
The Number of Days of Dysmenorrheic Pain at the End of Follow-up Period Compared With Baseline
|
-1.3 days
Standard Error 0.19
|
-1.5 days
Standard Error 0.21
|
-1.0 days
Standard Error 0.18
|
SECONDARY outcome
Timeframe: Baseline, end of treatment (6 months) and end of follow-up (9 months)Population: FAS: all randomized subjects who received at least 1 dose of study treatments, and had at least 1 valid postbaseline assessment of 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.
Outcome measures
| Measure |
KYG0395 (High Dose Group)
n=81 Participants
KYG0395: 3 KYG0395 capsules tid (morning, midday, and evening)
|
KYG0395 (Lower Dose Group)
n=77 Participants
KYG0395: 3 KYG0395 capsules 2 times a day (bid) (morning and evening) plus 3 capsules of placebo (midday)
|
Placebo
n=80 Participants
placebo: 3 capsules of placebo tid (morning, midday, and evening)
|
|---|---|---|---|
|
Average Daily Dysmenorrheic Pain VAS Score at the End of Treatment and Follow-up Period
at the end of treatment
|
-14.7 pills
Standard Error 2.12
|
-11.1 pills
Standard Error 2.29
|
-9.6 pills
Standard Error 2.11
|
|
Average Daily Dysmenorrheic Pain VAS Score at the End of Treatment and Follow-up Period
at the end of follow-up
|
-12.8 pills
Standard Error 2.15
|
-10.1 pills
Standard Error 2.33
|
-9.1 pills
Standard Error 2.04
|
SECONDARY outcome
Timeframe: Baseline, end of treatment (6 months) and end of follow-up (9 months)Population: FAS: all randomized subjects who received at least 1 dose of study treatments, and had at least 1 valid postbaseline assessment of dysmenorrheic pain VAS score
The change from baseline to the end of treatment and follow-up period in rescue medication consumption
Outcome measures
| Measure |
KYG0395 (High Dose Group)
n=81 Participants
KYG0395: 3 KYG0395 capsules tid (morning, midday, and evening)
|
KYG0395 (Lower Dose Group)
n=77 Participants
KYG0395: 3 KYG0395 capsules 2 times a day (bid) (morning and evening) plus 3 capsules of placebo (midday)
|
Placebo
n=80 Participants
placebo: 3 capsules of placebo tid (morning, midday, and evening)
|
|---|---|---|---|
|
Rescue Medication Consumption at the End of Treatment and Follow-up Period
end of follow-up
|
-2.2 pills
Standard Deviation 4.66
|
-2.6 pills
Standard Deviation 3.16
|
-2.9 pills
Standard Deviation 3.93
|
|
Rescue Medication Consumption at the End of Treatment and Follow-up Period
end of treatment
|
-2.6 pills
Standard Deviation 4.28
|
-2.0 pills
Standard Deviation 4.1
|
-2.0 pills
Standard Deviation 4.05
|
SECONDARY outcome
Timeframe: Base line and end of follow-up (9 months)Population: Full analysis set
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.
Outcome measures
| Measure |
KYG0395 (High Dose Group)
n=59 Participants
KYG0395: 3 KYG0395 capsules tid (morning, midday, and evening)
|
KYG0395 (Lower Dose Group)
n=49 Participants
KYG0395: 3 KYG0395 capsules 2 times a day (bid) (morning and evening) plus 3 capsules of placebo (midday)
|
Placebo
n=62 Participants
placebo: 3 capsules of placebo tid (morning, midday, and evening)
|
|---|---|---|---|
|
Subject's Overall Satisfaction at the End of the 3-cycle Follow-up Period
complete satisfaction
|
35.6 percentage of complete satisfaction
|
16.3 percentage of complete satisfaction
|
24.2 percentage of complete satisfaction
|
|
Subject's Overall Satisfaction at the End of the 3-cycle Follow-up Period
moderate satisfaction
|
25.4 percentage of complete satisfaction
|
49.0 percentage of complete satisfaction
|
40.3 percentage of complete satisfaction
|
|
Subject's Overall Satisfaction at the End of the 3-cycle Follow-up Period
mild satisfaction
|
18.6 percentage of complete satisfaction
|
26.5 percentage of complete satisfaction
|
19.4 percentage of complete satisfaction
|
Adverse Events
KYG0395 (High Dose Group)
KYG0395 (Lower Dose Group)
Placebo
Serious adverse events
| Measure |
KYG0395 (High Dose Group)
n=88 participants at risk
KYG0395: 3 KYG0395 capsules tid (morning, midday, and evening)
|
KYG0395 (Lower Dose Group)
n=90 participants at risk
KYG0395: 3 KYG0395 capsules 2 times a day (bid) (morning and evening) plus 3 capsules of placebo (midday)
|
Placebo
n=91 participants at risk
placebo: 3 capsules of placebo tid (morning, midday, and evening)
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
pneumonia
|
0.00%
0/88 • 6 months
|
0.00%
0/90 • 6 months
|
1.1%
1/91 • Number of events 1 • 6 months
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
1.1%
1/88 • Number of events 1 • 6 months
|
0.00%
0/90 • 6 months
|
0.00%
0/91 • 6 months
|
|
Reproductive system and breast disorders
Abortion
|
0.00%
0/88 • 6 months
|
1.1%
1/90 • Number of events 1 • 6 months
|
0.00%
0/91 • 6 months
|
Other adverse events
| Measure |
KYG0395 (High Dose Group)
n=88 participants at risk
KYG0395: 3 KYG0395 capsules tid (morning, midday, and evening)
|
KYG0395 (Lower Dose Group)
n=90 participants at risk
KYG0395: 3 KYG0395 capsules 2 times a day (bid) (morning and evening) plus 3 capsules of placebo (midday)
|
Placebo
n=91 participants at risk
placebo: 3 capsules of placebo tid (morning, midday, and evening)
|
|---|---|---|---|
|
Investigations
any TEAE
|
26.1%
23/88 • Number of events 23 • 6 months
|
25.6%
23/90 • Number of events 23 • 6 months
|
35.2%
32/91 • Number of events 32 • 6 months
|
|
Gastrointestinal disorders
Gastrointestinal disorders
|
11.4%
10/88 • Number of events 10 • 6 months
|
10.0%
9/90 • Number of events 9 • 6 months
|
9.9%
9/91 • Number of events 9 • 6 months
|
|
Infections and infestations
Infections and infestations
|
8.0%
7/88 • Number of events 7 • 6 months
|
7.8%
7/90 • Number of events 7 • 6 months
|
9.9%
9/91 • Number of events 9 • 6 months
|
|
General disorders
General disorders and administration site conditions
|
1.1%
1/88 • Number of events 1 • 6 months
|
3.3%
3/90 • Number of events 3 • 6 months
|
6.6%
6/91 • Number of events 6 • 6 months
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders
|
1.1%
1/88 • Number of events 1 • 6 months
|
2.2%
2/90 • Number of events 2 • 6 months
|
6.6%
6/91 • Number of events 6 • 6 months
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders
|
2.3%
2/88 • Number of events 2 • 6 months
|
3.3%
3/90 • Number of events 3 • 6 months
|
2.2%
2/91 • Number of events 2 • 6 months
|
|
Nervous system disorders
Nervous system disorders
|
2.3%
2/88 • Number of events 2 • 6 months
|
1.1%
1/90 • Number of events 1 • 6 months
|
3.3%
3/91 • Number of events 3 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER