Trial Outcomes & Findings for SH T00186 Phase II/ III Optimal Drospirenone (DRSP) Dose Finding and Placebo-controlled Comparative Study (NCT NCT00511797)
NCT ID: NCT00511797
Last Updated: 2017-01-26
Results Overview
Total dysmenorrheal score was defined as sum of 2 sub-scores: severity of dysmenorrhea (none: 0, mild: 1, moderate: 2, severe: 3) and use of analgesics (none: 0, mild: 1, moderate: 2, severe: 3). Total possible best is 0, and total possible worst is 6. Note: used with permission of Nobelpharma Co., Ltd. from the phase 3 clinical study protocol (Prog Med 2005:25 (3):739-758) of IKH-01 in dysmenorrhea (associated with endometriosis) (Nobelpharma Co., Ltd.)
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
249 participants
Primary outcome timeframe
Baseline and up to 4 Cycles (28 days per cycle)
Results posted on
2017-01-26
Participant Flow
Full Analysis Set (FAS) consisted of all patients who received at least one dose of study drug. Patients were analyzed as treated. FAS was the primary analysis set for all efficacy endpoints and safety analyses. Per Protocol Set (PPS) was a subgroup of the FAS. The PPS consisted of patients in the FAS who did not have major protocol deviations.
Participant milestones
| Measure |
DRSP 1 mg/EE 20 μg
1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
|
DRSP 2 mg/EE 20 μg
1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
|
DRSP 3 mg/EE 20 μg
1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
|
Placebo
1 tablet per day placebo for 28 days in each 28-day cycle
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
62
|
63
|
62
|
62
|
|
Overall Study
Subjects Dispensed Drugs
|
61
|
63
|
61
|
59
|
|
Overall Study
Subjects Received Treatment
|
61
|
62
|
61
|
58
|
|
Overall Study
COMPLETED
|
55
|
55
|
51
|
47
|
|
Overall Study
NOT COMPLETED
|
7
|
8
|
11
|
15
|
Reasons for withdrawal
| Measure |
DRSP 1 mg/EE 20 μg
1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
|
DRSP 2 mg/EE 20 μg
1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
|
DRSP 3 mg/EE 20 μg
1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
|
Placebo
1 tablet per day placebo for 28 days in each 28-day cycle
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
2
|
2
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
1
|
|
Overall Study
Pregnancy
|
0
|
0
|
0
|
1
|
|
Overall Study
Protocol Violation
|
0
|
2
|
2
|
3
|
|
Overall Study
Withdrawal by Subject
|
3
|
3
|
4
|
2
|
|
Overall Study
Never dispensed
|
1
|
0
|
1
|
3
|
|
Overall Study
Study drug not taken
|
0
|
1
|
0
|
1
|
|
Overall Study
Partially missing diary
|
0
|
0
|
1
|
0
|
|
Overall Study
Other (moving etc)
|
1
|
0
|
1
|
2
|
Baseline Characteristics
SH T00186 Phase II/ III Optimal Drospirenone (DRSP) Dose Finding and Placebo-controlled Comparative Study
Baseline characteristics by cohort
| Measure |
DRSP 1 mg/EE 20 μg
n=61 Participants
1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
|
DRSP 2 mg/EE 20 μg
n=62 Participants
1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
|
DRSP 3 mg/EE 20 μg
n=61 Participants
1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
|
Placebo
n=58 Participants
1 tablet per day placebo for 28 days in each 28-day cycle
|
Total
n=242 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
31.0 years
n=5 Participants
|
30.6 years
n=7 Participants
|
30.9 years
n=5 Participants
|
30.8 years
n=4 Participants
|
30.8 years
n=21 Participants
|
|
Gender
Female
|
61 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
58 Participants
n=4 Participants
|
242 Participants
n=21 Participants
|
|
Gender
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Diagnosis type
Functional dysmenorrhea
|
47 participants
n=5 Participants
|
48 participants
n=7 Participants
|
42 participants
n=5 Participants
|
41 participants
n=4 Participants
|
178 participants
n=21 Participants
|
|
Diagnosis type
Organic dysmenorrhea
|
14 participants
n=5 Participants
|
14 participants
n=7 Participants
|
19 participants
n=5 Participants
|
17 participants
n=4 Participants
|
64 participants
n=21 Participants
|
|
Details of organic dysmenorrhea
Endometriosis
|
1 participants
n=5 Participants
|
3 participants
n=7 Participants
|
4 participants
n=5 Participants
|
5 participants
n=4 Participants
|
13 participants
n=21 Participants
|
|
Details of organic dysmenorrhea
Uterine fibroids
|
9 participants
n=5 Participants
|
7 participants
n=7 Participants
|
10 participants
n=5 Participants
|
9 participants
n=4 Participants
|
35 participants
n=21 Participants
|
|
Details of organic dysmenorrhea
Uterine adenomyosis
|
6 participants
n=5 Participants
|
7 participants
n=7 Participants
|
11 participants
n=5 Participants
|
8 participants
n=4 Participants
|
32 participants
n=21 Participants
|
|
Details of organic dysmenorrhea
Bicornuate uterus
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
2 participants
n=21 Participants
|
|
Average length of menstrual cycle
|
28.6 days
n=5 Participants
|
28.7 days
n=7 Participants
|
28.3 days
n=5 Participants
|
28.7 days
n=4 Participants
|
28.6 days
n=21 Participants
|
|
Body mass index (BMI)
|
21.05 kg/m^2
n=5 Participants
|
20.41 kg/m^2
n=7 Participants
|
20.67 kg/m^2
n=5 Participants
|
21.19 kg/m^2
n=4 Participants
|
20.82 kg/m^2
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline and up to 4 Cycles (28 days per cycle)Population: FAS
Total dysmenorrheal score was defined as sum of 2 sub-scores: severity of dysmenorrhea (none: 0, mild: 1, moderate: 2, severe: 3) and use of analgesics (none: 0, mild: 1, moderate: 2, severe: 3). Total possible best is 0, and total possible worst is 6. Note: used with permission of Nobelpharma Co., Ltd. from the phase 3 clinical study protocol (Prog Med 2005:25 (3):739-758) of IKH-01 in dysmenorrhea (associated with endometriosis) (Nobelpharma Co., Ltd.)
Outcome measures
| Measure |
DRSP 1 mg/EE 20 μg
n=61 Participants
1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
|
DRSP 2 mg/EE 20 μg
n=62 Participants
1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
|
DRSP 3 mg/EE 20 μg
n=61 Participants
1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
|
Placebo
n=58 Participants
1 tablet per day placebo for 28 days in each 28-day cycle
|
|---|---|---|---|---|
|
Change From Baseline in Total Dysmenorrheal Score at Final Evaluation
|
-2.5 scores on a scale
Standard Deviation 1.52
|
-2.1 scores on a scale
Standard Deviation 1.51
|
-1.9 scores on a scale
Standard Deviation 1.63
|
-1.0 scores on a scale
Standard Deviation 1.53
|
SECONDARY outcome
Timeframe: Baseline and up to 4 Cycles (28 days per cycle)Population: FAS
Total dysmenorrheal score was defined as sum of 2 sub-scores: severity of dysmenorrhea (none: 0, mild: 1, moderate: 2, severe: 3) and use of analgesics (none: 0, mild: 1, moderate: 2, severe: 3). Total possible best is 0, and total possible worst is 6.
Outcome measures
| Measure |
DRSP 1 mg/EE 20 μg
n=61 Participants
1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
|
DRSP 2 mg/EE 20 μg
n=62 Participants
1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
|
DRSP 3 mg/EE 20 μg
n=61 Participants
1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
|
Placebo
n=58 Participants
1 tablet per day placebo for 28 days in each 28-day cycle
|
|---|---|---|---|---|
|
Change From Baseline in Total Dysmenorrheal Score at Cycle 1 up to Cycle 4
Cycle 1
|
-2.4 scores on a scale
Standard Deviation 1.40
|
-2.1 scores on a scale
Standard Deviation 1.49
|
-1.8 scores on a scale
Standard Deviation 1.67
|
-0.8 scores on a scale
Standard Deviation 1.50
|
|
Change From Baseline in Total Dysmenorrheal Score at Cycle 1 up to Cycle 4
Cycle 2
|
-2.1 scores on a scale
Standard Deviation 1.40
|
-2.3 scores on a scale
Standard Deviation 1.57
|
-1.9 scores on a scale
Standard Deviation 1.50
|
-1.1 scores on a scale
Standard Deviation 1.59
|
|
Change From Baseline in Total Dysmenorrheal Score at Cycle 1 up to Cycle 4
Cycle 3
|
-2.5 scores on a scale
Standard Deviation 1.34
|
-2.3 scores on a scale
Standard Deviation 1.52
|
-2.1 scores on a scale
Standard Deviation 1.34
|
-1.0 scores on a scale
Standard Deviation 1.59
|
|
Change From Baseline in Total Dysmenorrheal Score at Cycle 1 up to Cycle 4
Cycle 4
|
-2.5 scores on a scale
Standard Deviation 1.55
|
-2.3 scores on a scale
Standard Deviation 1.41
|
-2.1 scores on a scale
Standard Deviation 1.54
|
-1.0 scores on a scale
Standard Deviation 1.63
|
SECONDARY outcome
Timeframe: Cycle 4 (28 days per cycle)Population: FAS (Participants with data at Cycle 4)
Severity of lower abdominal pain during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities).
Outcome measures
| Measure |
DRSP 1 mg/EE 20 μg
n=55 Participants
1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
|
DRSP 2 mg/EE 20 μg
n=53 Participants
1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
|
DRSP 3 mg/EE 20 μg
n=51 Participants
1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
|
Placebo
n=46 Participants
1 tablet per day placebo for 28 days in each 28-day cycle
|
|---|---|---|---|---|
|
Number of Participants With Severity of Lower Abdominal Pain During Menstruation at Cycle 4
none
|
15 participants
|
17 participants
|
11 participants
|
3 participants
|
|
Number of Participants With Severity of Lower Abdominal Pain During Menstruation at Cycle 4
mild
|
28 participants
|
27 participants
|
19 participants
|
11 participants
|
|
Number of Participants With Severity of Lower Abdominal Pain During Menstruation at Cycle 4
moderate
|
9 participants
|
7 participants
|
14 participants
|
21 participants
|
|
Number of Participants With Severity of Lower Abdominal Pain During Menstruation at Cycle 4
severe
|
3 participants
|
2 participants
|
7 participants
|
11 participants
|
SECONDARY outcome
Timeframe: Cycle 4 (28 days per cycle)Population: FAS (Participants with data at Cycle 4)
Severity of low back pain during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities).
Outcome measures
| Measure |
DRSP 1 mg/EE 20 μg
n=55 Participants
1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
|
DRSP 2 mg/EE 20 μg
n=53 Participants
1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
|
DRSP 3 mg/EE 20 μg
n=51 Participants
1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
|
Placebo
n=46 Participants
1 tablet per day placebo for 28 days in each 28-day cycle
|
|---|---|---|---|---|
|
Number of Participants With Severity of Low Back Pain During Menstruation at Cycle 4
none
|
34 participants
|
36 participants
|
30 participants
|
18 participants
|
|
Number of Participants With Severity of Low Back Pain During Menstruation at Cycle 4
mild
|
15 participants
|
12 participants
|
18 participants
|
14 participants
|
|
Number of Participants With Severity of Low Back Pain During Menstruation at Cycle 4
moderate
|
5 participants
|
4 participants
|
2 participants
|
9 participants
|
|
Number of Participants With Severity of Low Back Pain During Menstruation at Cycle 4
severe
|
1 participants
|
1 participants
|
1 participants
|
5 participants
|
SECONDARY outcome
Timeframe: Cycle 4 (28 days per cycle)Population: FAS (Participants with data at Cycle 4)
Severity of headache during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities).
Outcome measures
| Measure |
DRSP 1 mg/EE 20 μg
n=55 Participants
1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
|
DRSP 2 mg/EE 20 μg
n=53 Participants
1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
|
DRSP 3 mg/EE 20 μg
n=51 Participants
1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
|
Placebo
n=46 Participants
1 tablet per day placebo for 28 days in each 28-day cycle
|
|---|---|---|---|---|
|
Number of Participants With Severity of Headache During Menstruation at Cycle 4
none
|
47 participants
|
35 participants
|
39 participants
|
29 participants
|
|
Number of Participants With Severity of Headache During Menstruation at Cycle 4
mild
|
5 participants
|
10 participants
|
5 participants
|
6 participants
|
|
Number of Participants With Severity of Headache During Menstruation at Cycle 4
moderate
|
1 participants
|
6 participants
|
3 participants
|
6 participants
|
|
Number of Participants With Severity of Headache During Menstruation at Cycle 4
severe
|
2 participants
|
2 participants
|
4 participants
|
5 participants
|
SECONDARY outcome
Timeframe: Cycle 4 (28 days per cycle)Population: FAS (Participants with data at Cycle 4)
Severity of nausea or vomiting during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities).
Outcome measures
| Measure |
DRSP 1 mg/EE 20 μg
n=55 Participants
1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
|
DRSP 2 mg/EE 20 μg
n=53 Participants
1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
|
DRSP 3 mg/EE 20 μg
n=51 Participants
1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
|
Placebo
n=46 Participants
1 tablet per day placebo for 28 days in each 28-day cycle
|
|---|---|---|---|---|
|
Number of Participants With Severity of Nausea or Vomiting During Menstruation at Cycle 4
none
|
51 participants
|
47 participants
|
47 participants
|
40 participants
|
|
Number of Participants With Severity of Nausea or Vomiting During Menstruation at Cycle 4
mild
|
2 participants
|
4 participants
|
4 participants
|
4 participants
|
|
Number of Participants With Severity of Nausea or Vomiting During Menstruation at Cycle 4
moderate
|
2 participants
|
1 participants
|
0 participants
|
2 participants
|
|
Number of Participants With Severity of Nausea or Vomiting During Menstruation at Cycle 4
severe
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Cycle 4 (28 days per cycle)Population: FAS (Participants with data at Cycle 4)
Total pelvic pain score was defined as sum of 2 sub-scores: severity of dysmenorrhea and use of analgesics. Higher score means it is more severe. 0=None, 6=Severest.
Outcome measures
| Measure |
DRSP 1 mg/EE 20 μg
n=55 Participants
1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
|
DRSP 2 mg/EE 20 μg
n=53 Participants
1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
|
DRSP 3 mg/EE 20 μg
n=51 Participants
1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
|
Placebo
n=46 Participants
1 tablet per day placebo for 28 days in each 28-day cycle
|
|---|---|---|---|---|
|
Number of Participants With Total Pelvic Pain Score at Times Other Than During Menstruation at Cycle 4
0
|
40 participants
|
41 participants
|
42 participants
|
30 participants
|
|
Number of Participants With Total Pelvic Pain Score at Times Other Than During Menstruation at Cycle 4
1
|
11 participants
|
10 participants
|
7 participants
|
6 participants
|
|
Number of Participants With Total Pelvic Pain Score at Times Other Than During Menstruation at Cycle 4
2
|
3 participants
|
2 participants
|
1 participants
|
5 participants
|
|
Number of Participants With Total Pelvic Pain Score at Times Other Than During Menstruation at Cycle 4
3
|
0 participants
|
0 participants
|
0 participants
|
3 participants
|
|
Number of Participants With Total Pelvic Pain Score at Times Other Than During Menstruation at Cycle 4
4
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Total Pelvic Pain Score at Times Other Than During Menstruation at Cycle 4
5
|
1 participants
|
0 participants
|
1 participants
|
1 participants
|
|
Number of Participants With Total Pelvic Pain Score at Times Other Than During Menstruation at Cycle 4
6
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: From baseline up to Cycle 4 (28 days per cycle)Population: FAS (Participants with data at Cycle 4)
VAS is an unmarked scale on a line 100 mm in length, indicating from 0 mm (no pain) to 100 mm (worst pain a participant has ever experienced).
Outcome measures
| Measure |
DRSP 1 mg/EE 20 μg
n=55 Participants
1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
|
DRSP 2 mg/EE 20 μg
n=53 Participants
1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
|
DRSP 3 mg/EE 20 μg
n=51 Participants
1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
|
Placebo
n=46 Participants
1 tablet per day placebo for 28 days in each 28-day cycle
|
|---|---|---|---|---|
|
Change From Baseline in Visual Analogue Scale (VAS) for Dysmenorrhea at Times Other Than During Menstruation at Cycle 4
|
-43.0 scores on a scale
Standard Deviation 23.44
|
-39.5 scores on a scale
Standard Deviation 22.12
|
-31.8 scores on a scale
Standard Deviation 23.55
|
-10.3 scores on a scale
Standard Deviation 24.53
|
SECONDARY outcome
Timeframe: Cycle 4 (28 days per cycle)Population: FAS (Participants with data at Cycle 4)
VAS is an unmarked scale on a line 100 mm in length, indicating from 0 mm (no pain) to 100 mm (worst pain a participant has ever experienced).
Outcome measures
| Measure |
DRSP 1 mg/EE 20 μg
n=55 Participants
1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
|
DRSP 2 mg/EE 20 μg
n=53 Participants
1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
|
DRSP 3 mg/EE 20 μg
n=51 Participants
1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
|
Placebo
n=46 Participants
1 tablet per day placebo for 28 days in each 28-day cycle
|
|---|---|---|---|---|
|
Visual Analogue Scale (VAS) for Pelvic Pain at Times Other Than During Menstruation at Cycle 4
|
5.9 scores on a scale
Standard Deviation 11.52
|
5.4 scores on a scale
Standard Deviation 11.78
|
4.0 scores on a scale
Standard Deviation 14.26
|
11.5 scores on a scale
Standard Deviation 20.22
|
SECONDARY outcome
Timeframe: From baseline to Cycle 4 (28 days per cycle)Population: FAS (Participants with data at Cycle 4)
Endometrial thickness was measured via transvaginal ultrasound examination. The endometrium is the inner membrane of the uterus. During the menstrual cycle, the endometrium grows to a thick, blood vessel-rich, glandular tissue layer.
Outcome measures
| Measure |
DRSP 1 mg/EE 20 μg
n=53 Participants
1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
|
DRSP 2 mg/EE 20 μg
n=53 Participants
1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
|
DRSP 3 mg/EE 20 μg
n=50 Participants
1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
|
Placebo
n=47 Participants
1 tablet per day placebo for 28 days in each 28-day cycle
|
|---|---|---|---|---|
|
Change From Baseline in Endometrial Thickness After 4-cycle Treatment
|
-5.5 mm
Standard Deviation 4.11
|
-7.1 mm
Standard Deviation 3.25
|
-6.3 mm
Standard Deviation 4.07
|
-0.1 mm
Standard Deviation 2.79
|
SECONDARY outcome
Timeframe: For the first 90 daysPopulation: FAS (Participants with the defined data)
Bleeding data were captured from the diary a participant recorded by herself. Bleeding is a genital bleeding. Spotting is a slight genital bleeding with participant's experience. An episode means a series of bleeding and/or spotting. The bleeding /spotting analyses are by intensity.
Outcome measures
| Measure |
DRSP 1 mg/EE 20 μg
n=59 Participants
1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
|
DRSP 2 mg/EE 20 μg
n=60 Participants
1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
|
DRSP 3 mg/EE 20 μg
n=57 Participants
1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
|
Placebo
n=56 Participants
1 tablet per day placebo for 28 days in each 28-day cycle
|
|---|---|---|---|---|
|
Number of Bleeding / Spotting Episodes
bleeding / spotting
|
3.3 number of episodes
Standard Deviation 0.9
|
3.3 number of episodes
Standard Deviation 1.3
|
3.4 number of episodes
Standard Deviation 0.9
|
2.9 number of episodes
Standard Deviation 0.9
|
|
Number of Bleeding / Spotting Episodes
bleeding only
|
0.5 number of episodes
Standard Deviation 0.9
|
0.4 number of episodes
Standard Deviation 0.8
|
0.3 number of episodes
Standard Deviation 0.5
|
0.4 number of episodes
Standard Deviation 0.8
|
|
Number of Bleeding / Spotting Episodes
spotting only
|
0.3 number of episodes
Standard Deviation 0.6
|
0.4 number of episodes
Standard Deviation 1.1
|
0.4 number of episodes
Standard Deviation 0.8
|
0.2 number of episodes
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: For the first 90 daysPopulation: FAS (Participants with the defined data)
Bleeding data were captured from the diary a participant recorded by herself. Bleeding is a genital bleeding. Spotting is a slight genital bleeding with participant's experience. The bleeding /spotting analyses are by intensity.
Outcome measures
| Measure |
DRSP 1 mg/EE 20 μg
n=59 Participants
1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
|
DRSP 2 mg/EE 20 μg
n=60 Participants
1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
|
DRSP 3 mg/EE 20 μg
n=57 Participants
1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
|
Placebo
n=56 Participants
1 tablet per day placebo for 28 days in each 28-day cycle
|
|---|---|---|---|---|
|
Number of Bleeding / Spotting Days
bleeding / spotting
|
32.3 days
Standard Deviation 8.7
|
31.2 days
Standard Deviation 11.4
|
29.2 days
Standard Deviation 11.0
|
22.6 days
Standard Deviation 5.5
|
|
Number of Bleeding / Spotting Days
bleeding only
|
21.3 days
Standard Deviation 5.9
|
19.3 days
Standard Deviation 8.8
|
18.6 days
Standard Deviation 6.5
|
17.4 days
Standard Deviation 4.9
|
|
Number of Bleeding / Spotting Days
spotting only
|
11.1 days
Standard Deviation 7.0
|
11.9 days
Standard Deviation 7.6
|
10.5 days
Standard Deviation 8.2
|
5.2 days
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: At Cycle 4 (28 days per cycle)Population: FAS (Participants with data at Cycle 4)
Withdrawal bleedings were defined as bleedings while a participant takes placebo tablets.
Outcome measures
| Measure |
DRSP 1 mg/EE 20 μg
n=55 Participants
1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
|
DRSP 2 mg/EE 20 μg
n=55 Participants
1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
|
DRSP 3 mg/EE 20 μg
n=52 Participants
1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
|
Placebo
n=48 Participants
1 tablet per day placebo for 28 days in each 28-day cycle
|
|---|---|---|---|---|
|
Participants With Withdrawal Bleeding
|
50 participants
|
50 participants
|
49 participants
|
47 participants
|
SECONDARY outcome
Timeframe: At Cycle 4 (28 days per cycle)Population: FAS (Participants with data at Cycle 4)
Intracyclic bleedings were defined as bleedings while a participant takes active drugs.
Outcome measures
| Measure |
DRSP 1 mg/EE 20 μg
n=55 Participants
1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
|
DRSP 2 mg/EE 20 μg
n=55 Participants
1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
|
DRSP 3 mg/EE 20 μg
n=52 Participants
1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
|
Placebo
n=48 Participants
1 tablet per day placebo for 28 days in each 28-day cycle
|
|---|---|---|---|---|
|
Participants With Intracyclic Bleeding
|
14 participants
|
8 participants
|
8 participants
|
4 participants
|
SECONDARY outcome
Timeframe: At Cycle 4 (28 days per cycle)Population: FAS (Participants with data at Cycle 4)
Non-heavy bleedings were defined as those other than heavy bleeding (less or normal bleeding).
Outcome measures
| Measure |
DRSP 1 mg/EE 20 μg
n=14 Participants
1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
|
DRSP 2 mg/EE 20 μg
n=8 Participants
1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
|
DRSP 3 mg/EE 20 μg
n=8 Participants
1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
|
Placebo
n=4 Participants
1 tablet per day placebo for 28 days in each 28-day cycle
|
|---|---|---|---|---|
|
Participants With Non-heavy Intracyclic Bleeding
|
14 participants
|
8 participants
|
7 participants
|
2 participants
|
SECONDARY outcome
Timeframe: At Cycle 4 (28 dyas per cycle)Population: FAS (Participants with data at Cycle 4)
Non-heavy bleedings were defined as those other than heavy bleeding (less or normal bleeding).
Outcome measures
| Measure |
DRSP 1 mg/EE 20 μg
n=50 Participants
1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
|
DRSP 2 mg/EE 20 μg
n=50 Participants
1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
|
DRSP 3 mg/EE 20 μg
n=49 Participants
1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
|
Placebo
n=47 Participants
1 tablet per day placebo for 28 days in each 28-day cycle
|
|---|---|---|---|---|
|
Participants With Non-heavy Withdrawal Bleeding
|
45 participants
|
44 participants
|
42 participants
|
38 participants
|
SECONDARY outcome
Timeframe: From baseline to Cycle 4 (28 days per cycle)Population: FAS (Participants with data at Cycle 4)
CA125 is a laboratory parameter giving an indication of having tumor, whose elevated levels that were defined by a lab suggest a potential tumor.
Outcome measures
| Measure |
DRSP 1 mg/EE 20 μg
n=55 Participants
1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
|
DRSP 2 mg/EE 20 μg
n=55 Participants
1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
|
DRSP 3 mg/EE 20 μg
n=51 Participants
1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
|
Placebo
n=47 Participants
1 tablet per day placebo for 28 days in each 28-day cycle
|
|---|---|---|---|---|
|
Change From Baseline in Serum Carbohydrate Antigen-125 (CA125) After 4-cycle Treatment
|
-2.78 Units/L
Interval -26.4 to 5.5
|
0.53 Units/L
Interval -17.4 to 184.9
|
-3.79 Units/L
Interval -35.6 to 32.5
|
0.89 Units/L
Interval -7.8 to 15.8
|
SECONDARY outcome
Timeframe: From baseline to Cycle 4 (28 days per cycle)Population: FAS (Participants with data at Cycle 4)
CRP is a laboratory parameter giving an indication of inflammation, whose elevated levels that were defined by a lab suggest a potential inflammation.
Outcome measures
| Measure |
DRSP 1 mg/EE 20 μg
n=55 Participants
1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
|
DRSP 2 mg/EE 20 μg
n=55 Participants
1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
|
DRSP 3 mg/EE 20 μg
n=51 Participants
1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
|
Placebo
n=47 Participants
1 tablet per day placebo for 28 days in each 28-day cycle
|
|---|---|---|---|---|
|
Change From Baseline in Serum C-reactive Protein (CRP) After 4-cycle Treatment
|
0.015 mg/dL
Interval -0.31 to 0.85
|
0.042 mg/dL
Interval -0.09 to 0.77
|
-0.014 mg/dL
Interval -2.73 to 0.35
|
-0.175 mg/dL
Interval -7.38 to 0.62
|
SECONDARY outcome
Timeframe: From baseline to Cycle 4 (28 days per cycle)Population: FAS (Participants with data at Cycle 4)
Estradiol is a predominant sex hormone that presents in female.
Outcome measures
| Measure |
DRSP 1 mg/EE 20 μg
n=55 Participants
1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
|
DRSP 2 mg/EE 20 μg
n=55 Participants
1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
|
DRSP 3 mg/EE 20 μg
n=51 Participants
1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
|
Placebo
n=48 Participants
1 tablet per day placebo for 28 days in each 28-day cycle
|
|---|---|---|---|---|
|
Change From Baseline in Serum Estradiol Level After 4-cycle Treatment
|
-18.32 pg/mL
Interval -341.5 to 968.9
|
-42.23 pg/mL
Interval -336.8 to 329.0
|
-98.02 pg/mL
Interval -477.8 to 231.2
|
49.20 pg/mL
Interval -182.7 to 310.3
|
SECONDARY outcome
Timeframe: From baseline to Cycle 4 (28 days per cycle)Population: FAS (Participants with data at Cycle 4)
Progesterone is a steroid hormone involving in the female menstrual cycle, pregnancy, etc.
Outcome measures
| Measure |
DRSP 1 mg/EE 20 μg
n=54 Participants
1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
|
DRSP 2 mg/EE 20 μg
n=53 Participants
1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
|
DRSP 3 mg/EE 20 μg
n=50 Participants
1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
|
Placebo
n=47 Participants
1 tablet per day placebo for 28 days in each 28-day cycle
|
|---|---|---|---|---|
|
Change From Baseline in Serum Progesterone Level at Cycle 4
|
-7.93 ng/mL
Interval -22.2 to 6.3
|
-8.23 ng/mL
Interval -23.6 to 5.7
|
-9.37 ng/mL
Interval -22.3 to 6.7
|
-0.27 ng/mL
Interval -20.6 to 18.7
|
POST_HOC outcome
Timeframe: From baseline to Cycle 4(28 days per cycle)Population: FAS (Participants with data at Cycle 4)
Total pelvic pain score was defined as sum of 2 sub-scores: severity of dysmenorrhea (none: 0, mild: 1, moderate: 2, severe: 3) and use of analgesics (none: 0, mild: 1, moderate: 2, severe: 3). Total possible best is 0, and total possible worst is 6.
Outcome measures
| Measure |
DRSP 1 mg/EE 20 μg
n=55 Participants
1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
|
DRSP 2 mg/EE 20 μg
n=53 Participants
1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
|
DRSP 3 mg/EE 20 μg
n=51 Participants
1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
|
Placebo
n=46 Participants
1 tablet per day placebo for 28 days in each 28-day cycle
|
|---|---|---|---|---|
|
Change From Baseline for Total Pelvic Pain Score at Times Other Than During Menstruation at Cycle 4
|
-0.1 scores on a scale
Standard Deviation 1.19
|
-0.3 scores on a scale
Standard Deviation 1.12
|
-0.1 scores on a scale
Standard Deviation 1.06
|
0.1 scores on a scale
Standard Deviation 1.22
|
POST_HOC outcome
Timeframe: Baseline and up to Cycle 4 (28 days per cycle)Population: FAS
Total dysmenorrheal score was defined as sum of 2 sub-scores: severity of dysmenorrhea (none: 0, mild: 1, moderate: 2, severe: 3) and use of analgesics (none: 0, mild: 1, moderate: 2, severe: 3). Total possible best is 0, and total possible worst is 6. Note: used with permission of Nobelpharma Co., Ltd. from the phase 3 clinical study protocol (Prog Med 2005:25 (3):739-758) of IKH-01 in dysmenorrhea (associated with endometriosis) (Nobelpharma Co., Ltd.)
Outcome measures
| Measure |
DRSP 1 mg/EE 20 μg
n=61 Participants
1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
|
DRSP 2 mg/EE 20 μg
n=62 Participants
1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
|
DRSP 3 mg/EE 20 μg
n=61 Participants
1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
|
Placebo
n=58 Participants
1 tablet per day placebo for 28 days in each 28-day cycle
|
|---|---|---|---|---|
|
Change From Baseline in Total Dysmenorrheal Score at Final Evaluation in Subgroups (1)
age: < 30 years
|
-2.2 scores on a scale
Standard Deviation 1.46
|
-2.4 scores on a scale
Standard Deviation 1.50
|
-1.9 scores on a scale
Standard Deviation 1.49
|
-1.2 scores on a scale
Standard Deviation 1.45
|
|
Change From Baseline in Total Dysmenorrheal Score at Final Evaluation in Subgroups (1)
age: >= 30 years
|
-2.8 scores on a scale
Standard Deviation 1.54
|
-1.9 scores on a scale
Standard Deviation 1.49
|
-1.9 scores on a scale
Standard Deviation 1.75
|
-0.8 scores on a scale
Standard Deviation 1.60
|
|
Change From Baseline in Total Dysmenorrheal Score at Final Evaluation in Subgroups (1)
weight: < 50 kg
|
-3.0 scores on a scale
Standard Deviation 1.30
|
-2.4 scores on a scale
Standard Deviation 0.99
|
-1.5 scores on a scale
Standard Deviation 1.39
|
-0.7 scores on a scale
Standard Deviation 1.65
|
|
Change From Baseline in Total Dysmenorrheal Score at Final Evaluation in Subgroups (1)
weight: >= 50kg
|
-2.1 scores on a scale
Standard Deviation 1.57
|
-2.0 scores on a scale
Standard Deviation 1.64
|
-2.2 scores on a scale
Standard Deviation 1.74
|
-1.1 scores on a scale
Standard Deviation 1.50
|
|
Change From Baseline in Total Dysmenorrheal Score at Final Evaluation in Subgroups (1)
functional dysmenorrhea
|
-2.3 scores on a scale
Standard Deviation 1.63
|
-2.1 scores on a scale
Standard Deviation 1.52
|
-1.8 scores on a scale
Standard Deviation 1.73
|
-1.0 scores on a scale
Standard Deviation 1.47
|
|
Change From Baseline in Total Dysmenorrheal Score at Final Evaluation in Subgroups (1)
organic dysmenorrhea
|
-2.9 scores on a scale
Standard Deviation 1.00
|
-2.1 scores on a scale
Standard Deviation 1.49
|
-2.3 scores on a scale
Standard Deviation 1.37
|
-1.0 scores on a scale
Standard Deviation 1.70
|
|
Change From Baseline in Total Dysmenorrheal Score at Final Evaluation in Subgroups (1)
with medical surgical history
|
-2.3 scores on a scale
Standard Deviation 1.62
|
-2.0 scores on a scale
Standard Deviation 1.50
|
-2.1 scores on a scale
Standard Deviation 1.61
|
-1.1 scores on a scale
Standard Deviation 1.68
|
|
Change From Baseline in Total Dysmenorrheal Score at Final Evaluation in Subgroups (1)
without medical surgical history
|
-2.6 scores on a scale
Standard Deviation 1.42
|
-2.3 scores on a scale
Standard Deviation 1.53
|
-1.8 scores on a scale
Standard Deviation 1.66
|
-0.8 scores on a scale
Standard Deviation 1.27
|
POST_HOC outcome
Timeframe: Baseline and up to 4 Cycles (28 days per cycle)Population: FAS
Total dysmenorrheal score was defined as sum of 2 sub-scores: severity of dysmenorrhea (none: 0, mild: 1, moderate: 2, severe: 3) and use of analgesics (none: 0, mild: 1, moderate: 2, severe: 3). Total possible best is 0, and total possible worst is 6. Note: used with permission of Nobelpharma Co., Ltd. from the phase 3 clinical study protocol (Prog Med 2005:25 (3):739-758) of IKH-01 in dysmenorrhea (associated with endometriosis) (Nobelpharma Co., Ltd.)
Outcome measures
| Measure |
DRSP 1 mg/EE 20 μg
n=61 Participants
1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
|
DRSP 2 mg/EE 20 μg
n=62 Participants
1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
|
DRSP 3 mg/EE 20 μg
n=61 Participants
1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
|
Placebo
n=58 Participants
1 tablet per day placebo for 28 days in each 28-day cycle
|
|---|---|---|---|---|
|
Change From Baseline in Total Dysmenorrheal Score at Final Evaluation in Subgroups (2)
with previous medication
|
-2.5 scores on a scale
Standard Deviation 1.53
|
-2.1 scores on a scale
Standard Deviation 1.51
|
-1.9 scores on a scale
Standard Deviation 1.63
|
-1.0 scores on a scale
Standard Deviation 1.53
|
|
Change From Baseline in Total Dysmenorrheal Score at Final Evaluation in Subgroups (2)
with pregnancy history
|
-2.7 scores on a scale
Standard Deviation 1.62
|
-1.9 scores on a scale
Standard Deviation 1.32
|
-2.2 scores on a scale
Standard Deviation 1.72
|
-1.0 scores on a scale
Standard Deviation 2.03
|
|
Change From Baseline in Total Dysmenorrheal Score at Final Evaluation in Subgroups (2)
without pregnancy history
|
-2.3 scores on a scale
Standard Deviation 1.47
|
-2.2 scores on a scale
Standard Deviation 1.62
|
-1.8 scores on a scale
Standard Deviation 1.61
|
-1.0 scores on a scale
Standard Deviation 1.22
|
|
Change From Baseline in Total Dysmenorrheal Score at Final Evaluation in Subgroups (2)
with birth history
|
-2.9 scores on a scale
Standard Deviation 1.59
|
-2.1 scores on a scale
Standard Deviation 1.28
|
-2.3 scores on a scale
Standard Deviation 1.96
|
-1.1 scores on a scale
Standard Deviation 2.00
|
|
Change From Baseline in Total Dysmenorrheal Score at Final Evaluation in Subgroups (2)
without birth history
|
-2.3 scores on a scale
Standard Deviation 1.49
|
-2.1 scores on a scale
Standard Deviation 1.62
|
-1.9 scores on a scale
Standard Deviation 1.55
|
-1.0 scores on a scale
Standard Deviation 1.35
|
|
Change From Baseline in Total Dysmenorrheal Score at Final Evaluation in Subgroups (2)
total dysmenorrheal score at baseline: 3 or 4
|
-2.1 scores on a scale
Standard Deviation 1.28
|
-1.9 scores on a scale
Standard Deviation 1.36
|
-1.8 scores on a scale
Standard Deviation 1.44
|
-1.0 scores on a scale
Standard Deviation 1.49
|
|
Change From Baseline in Total Dysmenorrheal Score at Final Evaluation in Subgroups (2)
total dysmenorrheal score at baseline: 5 or 6
|
-3.4 scores on a scale
Standard Deviation 1.75
|
-2.6 scores on a scale
Standard Deviation 1.77
|
-2.4 scores on a scale
Standard Deviation 2.06
|
-1.1 scores on a scale
Standard Deviation 1.65
|
POST_HOC outcome
Timeframe: Baseline and up to 4 Cycles (28 days per cycle)Population: The number of subjects without previous medication in DRSP 1 mg/EE 20 μg group was 1, so the standard deviation was not measurable. The number of subjects without previous medication in the other three groups were 0, so the data were not applicable.
Total dysmenorrheal score was defined as sum of 2 sub-scores: severity of dysmenorrhea (none: 0, mild: 1, moderate: 2, severe: 3) and use of analgesics (none: 0, mild: 1, moderate: 2, severe: 3). Total possible best is 0, and total possible worst is 6. Note: used with permission of Nobelpharma Co., Ltd. from the phase 3 clinical study protocol (Prog Med 2005:25 (3):739-758) of IKH-01 in dysmenorrhea (associated with endometriosis) (Nobelpharma Co., Ltd.)
Outcome measures
| Measure |
DRSP 1 mg/EE 20 μg
n=1 Participants
1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
|
DRSP 2 mg/EE 20 μg
1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
|
DRSP 3 mg/EE 20 μg
1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
|
Placebo
1 tablet per day placebo for 28 days in each 28-day cycle
|
|---|---|---|---|---|
|
Change From Baseline in Total Dysmenorrheal Score at Final Evaluation in Patients Without Previous Medication
|
-2.0 scores on a scale
|
—
|
—
|
—
|
Adverse Events
DRSP 1 mg/EE 20 μg
Serious events: 1 serious events
Other events: 56 other events
Deaths: 0 deaths
DRSP 2 mg/EE 20 μg
Serious events: 2 serious events
Other events: 58 other events
Deaths: 0 deaths
DRSP 3 mg/EE 20 μg
Serious events: 0 serious events
Other events: 60 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 53 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DRSP 1 mg/EE 20 μg
n=62 participants at risk
1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
|
DRSP 2 mg/EE 20 μg
n=63 participants at risk
1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
|
DRSP 3 mg/EE 20 μg
n=62 participants at risk
1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
|
Placebo
n=62 participants at risk
1 tablet per day placebo for 28 days in each 28-day cycle
|
|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Henoch-Schonlein purpura
|
1.6%
1/62 • Number of events 1
|
0.00%
0/63
|
0.00%
0/62
|
0.00%
0/62
|
|
Infections and infestations
Appendicitis
|
0.00%
0/62
|
1.6%
1/63 • Number of events 1
|
0.00%
0/62
|
0.00%
0/62
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.00%
0/62
|
0.00%
0/63
|
0.00%
0/62
|
1.6%
1/62 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma stage 0
|
0.00%
0/62
|
1.6%
1/63 • Number of events 1
|
0.00%
0/62
|
0.00%
0/62
|
Other adverse events
| Measure |
DRSP 1 mg/EE 20 μg
n=62 participants at risk
1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
|
DRSP 2 mg/EE 20 μg
n=63 participants at risk
1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
|
DRSP 3 mg/EE 20 μg
n=62 participants at risk
1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
|
Placebo
n=62 participants at risk
1 tablet per day placebo for 28 days in each 28-day cycle
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain lower
|
8.1%
5/62 • Number of events 5
|
11.1%
7/63 • Number of events 10
|
14.5%
9/62 • Number of events 10
|
4.8%
3/62 • Number of events 4
|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.2%
2/62 • Number of events 6
|
7.9%
5/63 • Number of events 6
|
1.6%
1/62 • Number of events 1
|
1.6%
1/62 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.5%
4/62 • Number of events 4
|
12.7%
8/63 • Number of events 10
|
4.8%
3/62 • Number of events 3
|
6.5%
4/62 • Number of events 4
|
|
Investigations
Blood triglycerides increased
|
8.1%
5/62 • Number of events 5
|
1.6%
1/63 • Number of events 1
|
4.8%
3/62 • Number of events 3
|
0.00%
0/62
|
|
Gastrointestinal disorders
Constipation
|
6.5%
4/62 • Number of events 5
|
3.2%
2/63 • Number of events 2
|
4.8%
3/62 • Number of events 3
|
1.6%
1/62 • Number of events 2
|
|
Nervous system disorders
Dizziness
|
1.6%
1/62 • Number of events 1
|
1.6%
1/63 • Number of events 1
|
8.1%
5/62 • Number of events 7
|
3.2%
2/62 • Number of events 2
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
25.8%
16/62 • Number of events 30
|
28.6%
18/63 • Number of events 26
|
35.5%
22/62 • Number of events 47
|
41.9%
26/62 • Number of events 58
|
|
Nervous system disorders
Headache
|
33.9%
21/62 • Number of events 48
|
44.4%
28/63 • Number of events 84
|
48.4%
30/62 • Number of events 63
|
37.1%
23/62 • Number of events 68
|
|
General disorders
Malaise
|
3.2%
2/62 • Number of events 3
|
6.3%
4/63 • Number of events 4
|
4.8%
3/62 • Number of events 4
|
0.00%
0/62
|
|
Reproductive system and breast disorders
Metrorrhagia
|
32.3%
20/62 • Number of events 34
|
28.6%
18/63 • Number of events 32
|
12.9%
8/62 • Number of events 12
|
6.5%
4/62 • Number of events 7
|
|
Infections and infestations
Nasopharyngitis
|
27.4%
17/62 • Number of events 24
|
38.1%
24/63 • Number of events 35
|
38.7%
24/62 • Number of events 32
|
41.9%
26/62 • Number of events 32
|
|
Gastrointestinal disorders
Nausea
|
25.8%
16/62 • Number of events 28
|
28.6%
18/63 • Number of events 32
|
35.5%
22/62 • Number of events 31
|
27.4%
17/62 • Number of events 30
|
|
Investigations
Prothrombin time shortened
|
0.00%
0/62
|
3.2%
2/63 • Number of events 2
|
0.00%
0/62
|
6.5%
4/62 • Number of events 6
|
|
Immune system disorders
Seasonal allergy
|
6.5%
4/62 • Number of events 5
|
3.2%
2/63 • Number of events 2
|
6.5%
4/62 • Number of events 4
|
8.1%
5/62 • Number of events 5
|
|
Reproductive system and breast disorders
Breast discomfort
|
0.00%
0/62
|
4.8%
3/63 • Number of events 3
|
6.5%
4/62 • Number of events 4
|
1.6%
1/62 • Number of events 1
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
12.9%
8/62 • Number of events 8
|
12.7%
8/63 • Number of events 8
|
12.9%
8/62 • Number of events 9
|
12.9%
8/62 • Number of events 8
|
|
Reproductive system and breast disorders
Genital haemorrhage
|
32.3%
20/62 • Number of events 32
|
30.2%
19/63 • Number of events 31
|
37.1%
23/62 • Number of events 33
|
12.9%
8/62 • Number of events 8
|
|
Investigations
Coagulation test abnormal
|
14.5%
9/62 • Number of events 9
|
9.5%
6/63 • Number of events 6
|
21.0%
13/62 • Number of events 13
|
6.5%
4/62 • Number of events 4
|
|
Injury, poisoning and procedural complications
Procedural pain
|
4.8%
3/62 • Number of events 3
|
3.2%
2/63 • Number of events 2
|
6.5%
4/62 • Number of events 4
|
4.8%
3/62 • Number of events 3
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor will confirm the contents before disclosure.
- Publication restrictions are in place
Restriction type: OTHER