Dysmenorrhea
Conditions
Keywords
Dysmenorrhea, Intracyclic bleeding, Drospirenone (DRSP), Ethinylestradiol
Brief summary
The purpose of this study is to investigate efficacy of ethinylestradiol for intracyclic bleeding profile in patients with dysmenorrhea and to investigate the long term safety
Detailed description
The drospirenone 3 mg/ethinylestradiol 20 μg (13 cycles) group is to be treated by oral administration for 52 weeks, 13 cycles. The drospirenone 3 mg/ethinylestradiol 30 μg (6 cycles) group is to be treated by oral administration for 24 weeks, 6 cycles. The trial is sponsored by Bayer Yakuhin, Ltd.
Interventions
DRUGDRSP 3 mg/EE 20 µg (13 cycles)
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; treatment duration 52 weeks (13 cycles)
DRUGDRSP 3 mg/EE 30 µg (6 cycles)
1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients aged 20 years or older at obtaining informed consent * Patients having the normal menstrual cycle (25 to 38 days) in the latest two menses before the final enrollment * Patients having a total dysmenorrheal score of at least 3 points in twice of the latest menstruation before the final enrollment
Exclusion criteria
* Patients with ovarian chocolate cysts * Patients with fibroid needed to be treated * Patients with estrogen-dependent tumors and patients with cervical cancer or suspected cervical cancer * Patients with undiagnosed abnormal vaginal bleeding * Patients with thrombophlebitis, pulmonary embolism, cerebrovascular disease, or coronary artery disease or a history of those diseases * Patients aged 35 years or older who smoke at least 15 cigarettes per day * Patients with migraine accompanied by prodromata * Patients with pulmonary hypertension or valvular heart disease * Patients who are regularly taking nutritional products that contain St. John's Wort * Patients who underwent surgical treatment for endometriosis within 2 months prior to screening * Patients who may need to regularly use analgesics for therapeutic objectives other than relief from the pain of dysmenorrhea during this study (occasional use permitted)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Intracyclic Bleeding at Cycle 6 | Up to Cycle 6 (168 days) with 28 days per cycle | Intracyclic bleedings were defined as bleedings while a participant takes active tablets. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 13 | From baseline up to Cycle 13 (364 days) with 28 days per cycle | 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). Note: used with permission of Nobelpharma Co., Ltd. from the phase 3 clinical study protocol of IKH-01 in dysmenorrhea (associated with endometriosis) (Nobelpharma Co., Ltd.). Changed total dysmenorrheal scores: -6 to -1 mean improvement, 1 to 6 mean worsening, 0 means no change. |
| Distribution of Total Dysmenorrhea Score at Cycle 6 | Up to Cycle 6 (168 days) with 28 days per cycle | Total dysmenorrhea 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. |
| Distribution of Total Dysmenorrhea Score at Cycle 13 | Up to Cycle 13 (364 days) with 28 days per cycle | Total dysmenorrhea 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. |
| Distribution of Severity of Lower Abdominal Pain During Menstruation at Cycle 6 | Up to Cycle 6 (168 days) with 28 days per cycle | 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). |
| Distribution of Severity of Lower Abdominal Pain During Menstruation at Cycle 13 | Up to Cycle 13 (364 days) with 28 days per cycle | 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). |
| Distribution of Severity of Lumbago During Menstruation at Cycle 6 | Up to Cycle 6 (168 days) with 28 days per cycle | Severity of lumbago 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). |
| Distribution of Severity of Lumbago During Menstruation at Cycle 13 | Up to Cycle 13 (364 days) with 28 days per cycle | Severity of lumbago 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). |
| Distribution of Severity of Headache During Menstruation at Cycle 6 | Up to Cycle 6 (168 days) with 28 days per cycle | 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). |
| Distribution of Severity of Headache During Menstruation at Cycle 13 | Up to Cycle 13 (364 days) with 28 days per cycle | 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). |
| Distribution of Severity of Nausea or Vomiting During Menstruation at Cycle 6 | Up to Cycle 6 (168 days) with 28 days per cycle | 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). |
| Distribution of Severity of Nausea or Vomiting During Menstruation at Cycle 13 | Up to Cycle 13 (364 days) with 28 days per cycle | 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). |
| Number of Participants With a Total Pelvic Pain Score of 0 up to 6 at Times Other Than During Menstruation at Cycle 6 | Up to Cycle 6 (168 days) with 28 days per cycle | 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. |
| Number of Participants With a Total Pelvic Pain Score of 0 up to 6 at Times Other Than During Menstruation at Cycle 13 | Up to Cycle 13 (364 days) with 28 days per cycle | 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. |
| Change in Serum C-reactive Protein (CRP) From Baseline to Cycle 6 | From baseline up to Cycle 6 (168 days) with 28 days per cycle | CRP is a laboratory parameter giving an indication of inflammation, whose elevated level suggests a potential inflammation. |
| Change in Visual Analogue Scale (VAS) for Dysmenorrhea at Times Other Than During Menstruation From Baseline to Cycle 6 | From baseline up to Cycle 6 (168 days) with 28 days per cycle | 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). |
| Change in Visual Analogue Scale (VAS) for Dysmenorrhea at Times Other Than During Menstruation From Baseline to Cycle 13 | From baseline up to Cycle 13 (364 days) with 28 days per cycle | 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). |
| Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 6 | From baseline up to Cycle 6 (168 days) with 28 days per cycle | 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). Note: used with permission of Nobelpharma Co., Ltd. from the phase 3 clinical study protocol of IKH-01 in dysmenorrhea (associated with endometriosis) (Nobelpharma Co., Ltd.). Changed total dysmenorrheal scores: -6 to -1 mean improvement, 1 to 6 mean worsening, 0 means no change. |
| Change in Visual Analogue Scale (VAS) for Pelvic Pain at Times Other Than During Menstruation From Baseline to Cycle 13 | From baseline up to Cycle 13 (364 days) with 28 days per cycle | 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). |
| Number of Any Bleeding Episodes From Cycle 1 to Cycle 6 | Up to Cycle 6 (168 days) with 28 days per cycle | Vaginal bleeding was rated as none, spotting, light, normal, or heavy based on the participant's experience. A reference period is about 3 cycles (90 days): reference period 1 is from Cycle 1 to Cycle 3 (the 1st 90 days), reference period 2 is from Cycle 4 to Cycle 6 (the 2nd 90 days). |
| Number of Any Bleeding Episodes From Cycle 1 to Cycle 13 | Up to Cycle 13 (364 days) with 28 days per cycle | Vaginal bleeding was rated as none, spotting, light, normal, or heavy based on the participant's experience. A reference period is about 3 cycles (90 days): reference period 1 is from Cycle 1 to Cycle 3 (the 1st 90 days), reference period 2 is from Cycle 4 to Cycle 6 (the 2nd 90 days), reference period 3 is from Cycle 7 to Cycle 9 (the 3rd 90 days), reference period 4 is from Cycle 10 to Cycle 12 (the 4th 90 days). |
| Number of Any Bleeding Days From Cycle 1 to Cycle 6 | Up to Cycle 6 (168 days) with 28 days per cycle | Vaginal bleeding was rated as none, spotting, light, normal, or heavy based on the participant's experience. A reference period is about 3 cycles (90 days): reference period 1 is from Cycle 1 to Cycle 3 (the 1st 90 days), reference period 2 is from Cycle 4 to Cycle 6 (the 2nd 90 days). |
| Number of Any Bleeding Days From Cycle 1 to Cycle 13 | Up to Cycle 13 (364 days) with 28 days per cycle | Vaginal bleeding was rated as none, spotting, light, normal, or heavy based on the participant's experience. A reference period is about 3 cycles (90 days): reference period 1 is from Cycle 1 to Cycle 4 (the 1st 90 days), reference period 2 is from Cycle 4 to Cycle 6 (the 2nd 90 days), reference period 3 is from Cycle 7 to Cycle 9 (the 3rd 90 days), reference period 4 is from Cycle 10 to Cycle 12 (the 4th 90 days). |
| Number of Participants With Intracyclic Bleeding From Cycle 1 to Cycle 6 | Up to Cycle 6 (168 days) with 28 days per cycle | Intracyclic bleedings were defined as bleedings while a participant takes active tablets. |
| Number of Participants With Intracyclic Bleeding From Cycle 1 to Cycle 13 | Up to Cycle 13 (364 days) with 28 days per cycle | Intracyclic bleedings were defined as bleedings while a participant takes active tablets. |
| Number of Participants With Withdrawal Bleeding From Cycle 1 to Cycle 6 | Up to Cycle 6 (168 days) with 28 days per cycle | Withdrawal bleedings were defined as bleedings while a participant takes placebo tablets. |
| Change in Serum CRP From Baseline to Cycle 13 | From baseline up to Cycle 13 (364 days) with 28 days per cycle | CRP is a laboratory parameter giving an indication of inflammation, whose elevated level suggests a potential inflammation. |
| Number of Participants With Withdrawal Bleeding From Cycle 1 to Cycle 13 | Up to Cycle 13 (364 days) with 28 days per cycle | Withdrawal bleedings were defined as bleedings while a participant takes placebo tablets. |
| Percentage of Participants With Non-heavy Intracyclic Bleeding From Cycle 1 to Cycle 6 | Up to Cycle 6 (168 days) with 28 days per cycle | Non-heavy bleeding was defined as those other than heavy bleeding (i.e. spotting, light, or normal bleeding). |
| Percentage of Participants With Non-heavy Intracyclic Bleeding From Cycle 1 to Cycle 13 | Up to Cycle 13 (364 days) with 28 days per cycle | Non-heavy bleeding was defined as those other than heavy bleeding (i.e. spotting, light, or normal bleeding). |
| Percentage of Participants With Non-heavy Withdrawal Bleeding From Cycle 1 to Cycle 6 | Up to Cycle 6 (168 days) with 28 days per cycle | Non-heavy bleeding was defined as those other than heavy bleeding (i.e. spotting, light, or normal bleeding). |
| Percentage of Participants With Non-heavy Withdrawal Bleeding From Cycle 1 to Cycle 13 | Up to Cycle 13 (364 days) with 28 days per cycle | Non-heavy bleeding was defined as those other than heavy bleeding (i.e. spotting, light, or normal bleeding). |
| Change in Serum Carbohydrate Antigen-125 (CA-125) From Baseline to Cycle 6 | From baseline up to Cycle 6 (168 days) with 28 days per cycle | CA125 is a laboratory parameter giving an indication of having tumor, whose elevated levels that were defined by a lab suggest a potential tumor. |
| Change in Serum CA-125 From Baseline to Cycle 13 | From baseline up to Cycle 13 (364 days) with 28 days per cycle | CA125 is a laboratory parameter giving an indication of having tumor, whose elevated levels that were defined by a lab suggest a potential tumor. |
| Change in Visual Analogue Scale (VAS) for Pelvic Pain at Times Other Than During Menstruation From Baseline to Cycle 6 | From baseline up to Cycle 6 (168 days) with 28 days per cycle | 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). |
Countries
Japan
Participant flow
Pre-assignment details
Full Analysis Set (FAS) consisted of all patients randomized who received at least one dose of study drug. Patients were analyzed as treated. FAS was the primary analysis set for the efficacy and safety. Per Protocol Set (PPS) was a subgroup of the FAS. The PPS consisted of patients in the FAS without major protocol deviations reported by Cycle 6.
Participants by arm
| Arm | Count |
|---|---|
| DRSP 3 mg/EE 20 µg (13 Cycles) 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; treatment duration 52 weeks (13 cycles) | 349 |
| DRSP 3 mg/EE 30 µg (6 Cycles) 1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles) | 65 |
| Total | 414 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Continued Treatment | Adverse Event | 26 | 0 |
| Continued Treatment | Lost to Follow-up | 4 | 0 |
| Continued Treatment | Other (missing drug etc) | 2 | 0 |
| Continued Treatment | Partially missing diary | 2 | 0 |
| Continued Treatment | Protocol Violation | 13 | 0 |
| Continued Treatment | Withdrawal by Subject | 48 | 0 |
| Treatment | Adverse Event | 26 | 3 |
| Treatment | Lost to Follow-up | 4 | 2 |
| Treatment | Never dispensed | 5 | 0 |
| Treatment | Other (missing drug etc) | 2 | 0 |
| Treatment | Partially missing diary | 2 | 0 |
| Treatment | Protocol Violation | 13 | 2 |
| Treatment | Study drug not taken | 1 | 0 |
| Treatment | Withdrawal by Subject | 48 | 2 |
Baseline characteristics
| Characteristic | DRSP 3 mg/EE 30 µg (6 Cycles) | DRSP 3 mg/EE 20 µg (13 Cycles) | Total |
|---|---|---|---|
| Age Continuous | 30.9 years | 29.0 years | 29.3 years |
| Average length of menstrual cycle | 29.5 days | 29.5 days | 29.5 days |
| Body Mass Index | 20.56 kg/m^2 | 20.73 kg/m^2 | 20.70 kg/m^2 |
| Details of organic dysmenorrhea Bicornuate uterus | 0 participants | 3 participants | 3 participants |
| Details of organic dysmenorrhea Endometrial polyp | 0 participants | 1 participants | 1 participants |
| Details of organic dysmenorrhea Endometriosis | 4 participants | 24 participants | 28 participants |
| Details of organic dysmenorrhea Multiple endometrial polyp | 0 participants | 1 participants | 1 participants |
| Details of organic dysmenorrhea Uterine adenomyosis | 8 participants | 35 participants | 43 participants |
| Details of organic dysmenorrhea Uterine enlargement | 0 participants | 1 participants | 1 participants |
| Details of organic dysmenorrhea Uterine fibroids | 7 participants | 27 participants | 34 participants |
| Diagnosis type Functional dysmenorrhea | 53 participants | 273 participants | 326 participants |
| Diagnosis type Organic dysmenorrhea | 12 participants | 76 participants | 88 participants |
| Sex: Female, Male Female | 65 Participants | 349 Participants | 414 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 335 / 355 | 63 / 65 |
| serious Total, serious adverse events | 5 / 355 | 0 / 65 |
Outcome results
Primary
Number of Participants With Intracyclic Bleeding at Cycle 6
Intracyclic bleedings were defined as bleedings while a participant takes active tablets.
Time frame: Up to Cycle 6 (168 days) with 28 days per cycle
Population: FAS (Participants with data at Cycle 6)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DRSP 3 mg/EE 20 µg (6 Cycles) | Number of Participants With Intracyclic Bleeding at Cycle 6 | 40 participants |
| DRSP 3 mg/EE 30 µg (6 Cycles) | Number of Participants With Intracyclic Bleeding at Cycle 6 | 4 participants |
Comparison: Exact 95% confident intervals were calculated using F-distribution by treatment group. If the upper confidence limit is lower than 27.56% (threshold incidence), the treatment arm will be concluded to be acceptable. No group comparison was planned.95% CI: [9.73, 17.77]Binominal parameter by exact method
Comparison: Exact 95% confident intervals were calculated using F-distribution by treatment group.95% CI: [1.98, 17.29]Binominal parameter by exact method
Secondary
Change in Serum CA-125 From Baseline to Cycle 13
CA125 is a laboratory parameter giving an indication of having tumor, whose elevated levels that were defined by a lab suggest a potential tumor.
Time frame: From baseline up to Cycle 13 (364 days) with 28 days per cycle
Population: FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| DRSP 3 mg/EE 20 µg (6 Cycles) | Change in Serum CA-125 From Baseline to Cycle 13 | -4.66 Units/mL |
Secondary
Change in Serum Carbohydrate Antigen-125 (CA-125) From Baseline to Cycle 6
CA125 is a laboratory parameter giving an indication of having tumor, whose elevated levels that were defined by a lab suggest a potential tumor.
Time frame: From baseline up to Cycle 6 (168 days) with 28 days per cycle
Population: FAS(Participants with data at Cycle 6)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| DRSP 3 mg/EE 20 µg (6 Cycles) | Change in Serum Carbohydrate Antigen-125 (CA-125) From Baseline to Cycle 6 | -4.33 Units/mL |
| DRSP 3 mg/EE 30 µg (6 Cycles) | Change in Serum Carbohydrate Antigen-125 (CA-125) From Baseline to Cycle 6 | -5.50 Units/mL |
Secondary
Change in Serum C-reactive Protein (CRP) From Baseline to Cycle 6
CRP is a laboratory parameter giving an indication of inflammation, whose elevated level suggests a potential inflammation.
Time frame: From baseline up to Cycle 6 (168 days) with 28 days per cycle
Population: FAS(Participants with data at Cycle 6)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| DRSP 3 mg/EE 20 µg (6 Cycles) | Change in Serum C-reactive Protein (CRP) From Baseline to Cycle 6 | 0.159 mg/dL |
| DRSP 3 mg/EE 30 µg (6 Cycles) | Change in Serum C-reactive Protein (CRP) From Baseline to Cycle 6 | 0.000 mg/dL |
Secondary
Change in Serum CRP From Baseline to Cycle 13
CRP is a laboratory parameter giving an indication of inflammation, whose elevated level suggests a potential inflammation.
Time frame: From baseline up to Cycle 13 (364 days) with 28 days per cycle
Population: FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| DRSP 3 mg/EE 20 µg (6 Cycles) | Change in Serum CRP From Baseline to Cycle 13 | 0.014 mg/dL |
Secondary
Change in Visual Analogue Scale (VAS) for Dysmenorrhea at Times Other Than During Menstruation From Baseline to Cycle 13
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).
Time frame: From baseline up to Cycle 13 (364 days) with 28 days per cycle
Population: FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| DRSP 3 mg/EE 20 µg (6 Cycles) | Change in Visual Analogue Scale (VAS) for Dysmenorrhea at Times Other Than During Menstruation From Baseline to Cycle 13 | -41.6 scores on a scale |
Secondary
Change in Visual Analogue Scale (VAS) for Dysmenorrhea at Times Other Than During Menstruation From Baseline to Cycle 6
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).
Time frame: From baseline up to Cycle 6 (168 days) with 28 days per cycle
Population: FAS (Participants with data at Cycle 6)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| DRSP 3 mg/EE 20 µg (6 Cycles) | Change in Visual Analogue Scale (VAS) for Dysmenorrhea at Times Other Than During Menstruation From Baseline to Cycle 6 | -37.2 scores on a scale |
| DRSP 3 mg/EE 30 µg (6 Cycles) | Change in Visual Analogue Scale (VAS) for Dysmenorrhea at Times Other Than During Menstruation From Baseline to Cycle 6 | -31.9 scores on a scale |
Secondary
Change in Visual Analogue Scale (VAS) for Pelvic Pain at Times Other Than During Menstruation From Baseline to Cycle 13
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).
Time frame: From baseline up to Cycle 13 (364 days) with 28 days per cycle
Population: FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| DRSP 3 mg/EE 20 µg (6 Cycles) | Change in Visual Analogue Scale (VAS) for Pelvic Pain at Times Other Than During Menstruation From Baseline to Cycle 13 | 6.2 scores on a scale |
Secondary
Change in Visual Analogue Scale (VAS) for Pelvic Pain at Times Other Than During Menstruation From Baseline to Cycle 6
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).
Time frame: From baseline up to Cycle 6 (168 days) with 28 days per cycle
Population: FAS (Participants with data at Cycle 6)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| DRSP 3 mg/EE 20 µg (6 Cycles) | Change in Visual Analogue Scale (VAS) for Pelvic Pain at Times Other Than During Menstruation From Baseline to Cycle 6 | 6.7 scores on a scale |
| DRSP 3 mg/EE 30 µg (6 Cycles) | Change in Visual Analogue Scale (VAS) for Pelvic Pain at Times Other Than During Menstruation From Baseline to Cycle 6 | 12.2 scores on a scale |
Secondary
Distribution of Severity of Headache During Menstruation at Cycle 13
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).
Time frame: Up to Cycle 13 (364 days) with 28 days per cycle
Population: FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DRSP 3 mg/EE 20 µg (6 Cycles) | Distribution of Severity of Headache During Menstruation at Cycle 13 | none | 168 participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Distribution of Severity of Headache During Menstruation at Cycle 13 | mild | 38 participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Distribution of Severity of Headache During Menstruation at Cycle 13 | moderate | 30 participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Distribution of Severity of Headache During Menstruation at Cycle 13 | severe | 6 participants |
Secondary
Distribution of Severity of Headache During Menstruation at Cycle 6
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).
Time frame: Up to Cycle 6 (168 days) with 28 days per cycle
Population: FAS (Participants with data at Cycle 6)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DRSP 3 mg/EE 20 µg (6 Cycles) | Distribution of Severity of Headache During Menstruation at Cycle 6 | none | 187 participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Distribution of Severity of Headache During Menstruation at Cycle 6 | mild | 41 participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Distribution of Severity of Headache During Menstruation at Cycle 6 | moderate | 29 participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Distribution of Severity of Headache During Menstruation at Cycle 6 | severe | 15 participants |
| DRSP 3 mg/EE 30 µg (6 Cycles) | Distribution of Severity of Headache During Menstruation at Cycle 6 | severe | 2 participants |
| DRSP 3 mg/EE 30 µg (6 Cycles) | Distribution of Severity of Headache During Menstruation at Cycle 6 | none | 37 participants |
| DRSP 3 mg/EE 30 µg (6 Cycles) | Distribution of Severity of Headache During Menstruation at Cycle 6 | moderate | 11 participants |
| DRSP 3 mg/EE 30 µg (6 Cycles) | Distribution of Severity of Headache During Menstruation at Cycle 6 | mild | 4 participants |
Secondary
Distribution of Severity of Lower Abdominal Pain During Menstruation at Cycle 13
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).
Time frame: Up to Cycle 13 (364 days) with 28 days per cycle
Population: FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DRSP 3 mg/EE 20 µg (6 Cycles) | Distribution of Severity of Lower Abdominal Pain During Menstruation at Cycle 13 | none | 78 participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Distribution of Severity of Lower Abdominal Pain During Menstruation at Cycle 13 | mild | 106 participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Distribution of Severity of Lower Abdominal Pain During Menstruation at Cycle 13 | moderate | 47 participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Distribution of Severity of Lower Abdominal Pain During Menstruation at Cycle 13 | severe | 11 participants |
Secondary
Distribution of Severity of Lower Abdominal Pain During Menstruation at Cycle 6
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).
Time frame: Up to Cycle 6 (168 days) with 28 days per cycle
Population: FAS (Participants with data at Cycle 6)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DRSP 3 mg/EE 20 µg (6 Cycles) | Distribution of Severity of Lower Abdominal Pain During Menstruation at Cycle 6 | none | 75 participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Distribution of Severity of Lower Abdominal Pain During Menstruation at Cycle 6 | mild | 119 participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Distribution of Severity of Lower Abdominal Pain During Menstruation at Cycle 6 | moderate | 59 participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Distribution of Severity of Lower Abdominal Pain During Menstruation at Cycle 6 | severe | 19 participants |
| DRSP 3 mg/EE 30 µg (6 Cycles) | Distribution of Severity of Lower Abdominal Pain During Menstruation at Cycle 6 | severe | 5 participants |
| DRSP 3 mg/EE 30 µg (6 Cycles) | Distribution of Severity of Lower Abdominal Pain During Menstruation at Cycle 6 | none | 14 participants |
| DRSP 3 mg/EE 30 µg (6 Cycles) | Distribution of Severity of Lower Abdominal Pain During Menstruation at Cycle 6 | moderate | 16 participants |
| DRSP 3 mg/EE 30 µg (6 Cycles) | Distribution of Severity of Lower Abdominal Pain During Menstruation at Cycle 6 | mild | 19 participants |
Secondary
Distribution of Severity of Lumbago During Menstruation at Cycle 13
Severity of lumbago 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).
Time frame: Up to Cycle 13 (364 days) with 28 days per cycle
Population: FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DRSP 3 mg/EE 20 µg (6 Cycles) | Distribution of Severity of Lumbago During Menstruation at Cycle 13 | none | 148 participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Distribution of Severity of Lumbago During Menstruation at Cycle 13 | mild | 72 participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Distribution of Severity of Lumbago During Menstruation at Cycle 13 | moderate | 19 participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Distribution of Severity of Lumbago During Menstruation at Cycle 13 | severe | 3 participants |
Secondary
Distribution of Severity of Lumbago During Menstruation at Cycle 6
Severity of lumbago 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).
Time frame: Up to Cycle 6 (168 days) with 28 days per cycle
Population: FAS (Participants with data at Cycle 6)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DRSP 3 mg/EE 20 µg (6 Cycles) | Distribution of Severity of Lumbago During Menstruation at Cycle 6 | none | 154 participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Distribution of Severity of Lumbago During Menstruation at Cycle 6 | mild | 88 participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Distribution of Severity of Lumbago During Menstruation at Cycle 6 | moderate | 26 participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Distribution of Severity of Lumbago During Menstruation at Cycle 6 | severe | 4 participants |
| DRSP 3 mg/EE 30 µg (6 Cycles) | Distribution of Severity of Lumbago During Menstruation at Cycle 6 | severe | 2 participants |
| DRSP 3 mg/EE 30 µg (6 Cycles) | Distribution of Severity of Lumbago During Menstruation at Cycle 6 | none | 21 participants |
| DRSP 3 mg/EE 30 µg (6 Cycles) | Distribution of Severity of Lumbago During Menstruation at Cycle 6 | moderate | 2 participants |
| DRSP 3 mg/EE 30 µg (6 Cycles) | Distribution of Severity of Lumbago During Menstruation at Cycle 6 | mild | 29 participants |
Secondary
Distribution of Severity of Nausea or Vomiting During Menstruation at Cycle 13
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).
Time frame: Up to Cycle 13 (364 days) with 28 days per cycle
Population: FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DRSP 3 mg/EE 20 µg (6 Cycles) | Distribution of Severity of Nausea or Vomiting During Menstruation at Cycle 13 | none | 229 participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Distribution of Severity of Nausea or Vomiting During Menstruation at Cycle 13 | mild | 11 participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Distribution of Severity of Nausea or Vomiting During Menstruation at Cycle 13 | moderate | 2 participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Distribution of Severity of Nausea or Vomiting During Menstruation at Cycle 13 | severe | 0 participants |
Secondary
Distribution of Severity of Nausea or Vomiting During Menstruation at Cycle 6
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).
Time frame: Up to Cycle 6 (168 days) with 28 days per cycle
Population: FAS (Participants with data at Cycle 6)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DRSP 3 mg/EE 20 µg (6 Cycles) | Distribution of Severity of Nausea or Vomiting During Menstruation at Cycle 6 | none | 251 participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Distribution of Severity of Nausea or Vomiting During Menstruation at Cycle 6 | mild | 14 participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Distribution of Severity of Nausea or Vomiting During Menstruation at Cycle 6 | moderate | 4 participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Distribution of Severity of Nausea or Vomiting During Menstruation at Cycle 6 | severe | 3 participants |
| DRSP 3 mg/EE 30 µg (6 Cycles) | Distribution of Severity of Nausea or Vomiting During Menstruation at Cycle 6 | severe | 0 participants |
| DRSP 3 mg/EE 30 µg (6 Cycles) | Distribution of Severity of Nausea or Vomiting During Menstruation at Cycle 6 | none | 51 participants |
| DRSP 3 mg/EE 30 µg (6 Cycles) | Distribution of Severity of Nausea or Vomiting During Menstruation at Cycle 6 | moderate | 2 participants |
| DRSP 3 mg/EE 30 µg (6 Cycles) | Distribution of Severity of Nausea or Vomiting During Menstruation at Cycle 6 | mild | 1 participants |
Secondary
Distribution of Total Dysmenorrhea Score at Cycle 13
Total dysmenorrhea 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.
Time frame: Up to Cycle 13 (364 days) with 28 days per cycle
Population: FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DRSP 3 mg/EE 20 µg (6 Cycles) | Distribution of Total Dysmenorrhea Score at Cycle 13 | 0 | 73 participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Distribution of Total Dysmenorrhea Score at Cycle 13 | 1 | 66 participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Distribution of Total Dysmenorrhea Score at Cycle 13 | 2 | 41 participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Distribution of Total Dysmenorrhea Score at Cycle 13 | 3 | 24 participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Distribution of Total Dysmenorrhea Score at Cycle 13 | 4 | 24 participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Distribution of Total Dysmenorrhea Score at Cycle 13 | 5 | 13 participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Distribution of Total Dysmenorrhea Score at Cycle 13 | 6 | 1 participants |
Secondary
Distribution of Total Dysmenorrhea Score at Cycle 6
Total dysmenorrhea 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.
Time frame: Up to Cycle 6 (168 days) with 28 days per cycle
Population: FAS (Participants with data at Cycle 6)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DRSP 3 mg/EE 20 µg (6 Cycles) | Distribution of Total Dysmenorrhea Score at Cycle 6 | 5 | 17 participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Distribution of Total Dysmenorrhea Score at Cycle 6 | 2 | 49 participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Distribution of Total Dysmenorrhea Score at Cycle 6 | 6 | 1 participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Distribution of Total Dysmenorrhea Score at Cycle 6 | 0 | 65 participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Distribution of Total Dysmenorrhea Score at Cycle 6 | 4 | 19 participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Distribution of Total Dysmenorrhea Score at Cycle 6 | 1 | 79 participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Distribution of Total Dysmenorrhea Score at Cycle 6 | 3 | 42 participants |
| DRSP 3 mg/EE 30 µg (6 Cycles) | Distribution of Total Dysmenorrhea Score at Cycle 6 | 6 | 1 participants |
| DRSP 3 mg/EE 30 µg (6 Cycles) | Distribution of Total Dysmenorrhea Score at Cycle 6 | 2 | 9 participants |
| DRSP 3 mg/EE 30 µg (6 Cycles) | Distribution of Total Dysmenorrhea Score at Cycle 6 | 3 | 8 participants |
| DRSP 3 mg/EE 30 µg (6 Cycles) | Distribution of Total Dysmenorrhea Score at Cycle 6 | 4 | 3 participants |
| DRSP 3 mg/EE 30 µg (6 Cycles) | Distribution of Total Dysmenorrhea Score at Cycle 6 | 5 | 4 participants |
| DRSP 3 mg/EE 30 µg (6 Cycles) | Distribution of Total Dysmenorrhea Score at Cycle 6 | 0 | 13 participants |
| DRSP 3 mg/EE 30 µg (6 Cycles) | Distribution of Total Dysmenorrhea Score at Cycle 6 | 1 | 16 participants |
Secondary
Number of Any Bleeding Days From Cycle 1 to Cycle 13
Vaginal bleeding was rated as none, spotting, light, normal, or heavy based on the participant's experience. A reference period is about 3 cycles (90 days): reference period 1 is from Cycle 1 to Cycle 4 (the 1st 90 days), reference period 2 is from Cycle 4 to Cycle 6 (the 2nd 90 days), reference period 3 is from Cycle 7 to Cycle 9 (the 3rd 90 days), reference period 4 is from Cycle 10 to Cycle 12 (the 4th 90 days).
Time frame: Up to Cycle 13 (364 days) with 28 days per cycle
Population: FAS (Participants with the defined data, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| DRSP 3 mg/EE 20 µg (6 Cycles) | Number of Any Bleeding Days From Cycle 1 to Cycle 13 | Reference period 1 | 30.6 days |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Number of Any Bleeding Days From Cycle 1 to Cycle 13 | Reference period 2 | 19.8 days |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Number of Any Bleeding Days From Cycle 1 to Cycle 13 | Reference period 3 | 21.2 days |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Number of Any Bleeding Days From Cycle 1 to Cycle 13 | Reference period 4 | 17.7 days |
Secondary
Number of Any Bleeding Days From Cycle 1 to Cycle 6
Vaginal bleeding was rated as none, spotting, light, normal, or heavy based on the participant's experience. A reference period is about 3 cycles (90 days): reference period 1 is from Cycle 1 to Cycle 3 (the 1st 90 days), reference period 2 is from Cycle 4 to Cycle 6 (the 2nd 90 days).
Time frame: Up to Cycle 6 (168 days) with 28 days per cycle
Population: FAS (Participants with the defined data, values for Cycle 1 to Cycle 6 (Reference period 1 and Reference period 2) in the DRSP 3mg/EE 20 µg group were calculated based on incomplete data due to the cut-off date)
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| DRSP 3 mg/EE 20 µg (6 Cycles) | Number of Any Bleeding Days From Cycle 1 to Cycle 6 | Reference period 1 | 30.7 days |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Number of Any Bleeding Days From Cycle 1 to Cycle 6 | Reference period 2 | 19.3 days |
| DRSP 3 mg/EE 30 µg (6 Cycles) | Number of Any Bleeding Days From Cycle 1 to Cycle 6 | Reference period 1 | 28.9 days |
| DRSP 3 mg/EE 30 µg (6 Cycles) | Number of Any Bleeding Days From Cycle 1 to Cycle 6 | Reference period 2 | 19.9 days |
Secondary
Number of Any Bleeding Episodes From Cycle 1 to Cycle 13
Vaginal bleeding was rated as none, spotting, light, normal, or heavy based on the participant's experience. A reference period is about 3 cycles (90 days): reference period 1 is from Cycle 1 to Cycle 3 (the 1st 90 days), reference period 2 is from Cycle 4 to Cycle 6 (the 2nd 90 days), reference period 3 is from Cycle 7 to Cycle 9 (the 3rd 90 days), reference period 4 is from Cycle 10 to Cycle 12 (the 4th 90 days).
Time frame: Up to Cycle 13 (364 days) with 28 days per cycle
Population: FAS (Participants with the defined data, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| DRSP 3 mg/EE 20 µg (6 Cycles) | Number of Any Bleeding Episodes From Cycle 1 to Cycle 13 | Reference period 1 | 3.2 number of episodes |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Number of Any Bleeding Episodes From Cycle 1 to Cycle 13 | Reference period 2 | 3.5 number of episodes |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Number of Any Bleeding Episodes From Cycle 1 to Cycle 13 | Reference period 3 | 3.1 number of episodes |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Number of Any Bleeding Episodes From Cycle 1 to Cycle 13 | Reference period 4 | 3.2 number of episodes |
Secondary
Number of Any Bleeding Episodes From Cycle 1 to Cycle 6
Vaginal bleeding was rated as none, spotting, light, normal, or heavy based on the participant's experience. A reference period is about 3 cycles (90 days): reference period 1 is from Cycle 1 to Cycle 3 (the 1st 90 days), reference period 2 is from Cycle 4 to Cycle 6 (the 2nd 90 days).
Time frame: Up to Cycle 6 (168 days) with 28 days per cycle
Population: FAS (Participants with the defined data, values for Cycle 1 to Cycle 6 (Reference period 1 and Reference period 2) in the DRSP 3mg/EE 20 µg group were calculated based on incomplete data due to the cut-off date)
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| DRSP 3 mg/EE 20 µg (6 Cycles) | Number of Any Bleeding Episodes From Cycle 1 to Cycle 6 | Reference period 1 | 3.3 number of episodes |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Number of Any Bleeding Episodes From Cycle 1 to Cycle 6 | Reference period 2 | 3.3 number of episodes |
| DRSP 3 mg/EE 30 µg (6 Cycles) | Number of Any Bleeding Episodes From Cycle 1 to Cycle 6 | Reference period 1 | 3.4 number of episodes |
| DRSP 3 mg/EE 30 µg (6 Cycles) | Number of Any Bleeding Episodes From Cycle 1 to Cycle 6 | Reference period 2 | 3.1 number of episodes |
Secondary
Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 13
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). Note: used with permission of Nobelpharma Co., Ltd. from the phase 3 clinical study protocol of IKH-01 in dysmenorrhea (associated with endometriosis) (Nobelpharma Co., Ltd.). Changed total dysmenorrheal scores: -6 to -1 mean improvement, 1 to 6 mean worsening, 0 means no change.
Time frame: From baseline up to Cycle 13 (364 days) with 28 days per cycle
Population: FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DRSP 3 mg/EE 20 µg (6 Cycles) | Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 13 | -6 (change in total dysmenorrhea scores) | 4 participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 13 | -5 (change in total dysmenorrhea scores) | 22 participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 13 | -4 (change in total dysmenorrhea scores) | 47 participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 13 | -3 (change in total dysmenorrhea scores) | 68 participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 13 | -2 (change in total dysmenorrhea scores) | 44 participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 13 | -1 (change in total dysmenorrhea scores) | 32 participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 13 | 0 (change in total dysmenorrhea scores) | 12 participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 13 | 1 (change in total dysmenorrhea scores) | 11 participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 13 | 2 (change in total dysmenorrhea scores) | 2 participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 13 | 3 (change in total dysmenorrhea scores) | 0 participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 13 | 4 (change in total dysmenorrhea scores) | 0 participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 13 | 5 (change in total dysmenorrhea scores) | 0 participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 13 | 6 (change in total dysmenorrhea scores) | 0 participants |
Secondary
Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 6
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). Note: used with permission of Nobelpharma Co., Ltd. from the phase 3 clinical study protocol of IKH-01 in dysmenorrhea (associated with endometriosis) (Nobelpharma Co., Ltd.). Changed total dysmenorrheal scores: -6 to -1 mean improvement, 1 to 6 mean worsening, 0 means no change.
Time frame: From baseline up to Cycle 6 (168 days) with 28 days per cycle
Population: FAS (Participants with data at Cycle 6)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DRSP 3 mg/EE 20 µg (6 Cycles) | Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 6 | -4 (change in total dysmenorrhea scores) | 41 participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 6 | 1 (change in total dysmenorrhea scores) | 4 participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 6 | -2 (change in total dysmenorrhea scores) | 71 participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 6 | 2 (change in total dysmenorrhea scores) | 4 participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 6 | -5 (change in total dysmenorrhea scores) | 22 participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 6 | 3 (change in total dysmenorrhea scores) | 0 participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 6 | -1 (change in total dysmenorrhea scores) | 30 participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 6 | 4 (change in total dysmenorrhea scores) | 0 participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 6 | -3 (change in total dysmenorrhea scores) | 70 participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 6 | 5 (change in total dysmenorrhea scores) | 0 participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 6 | 0 (change in total dysmenorrhea scores) | 25 participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 6 | 6 (change in total dysmenorrhea scores) | 0 participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 6 | -6 (change in total dysmenorrhea scores) | 5 participants |
| DRSP 3 mg/EE 30 µg (6 Cycles) | Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 6 | 6 (change in total dysmenorrhea scores) | 0 participants |
| DRSP 3 mg/EE 30 µg (6 Cycles) | Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 6 | -6 (change in total dysmenorrhea scores) | 2 participants |
| DRSP 3 mg/EE 30 µg (6 Cycles) | Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 6 | -5 (change in total dysmenorrhea scores) | 3 participants |
| DRSP 3 mg/EE 30 µg (6 Cycles) | Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 6 | -4 (change in total dysmenorrhea scores) | 8 participants |
| DRSP 3 mg/EE 30 µg (6 Cycles) | Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 6 | -3 (change in total dysmenorrhea scores) | 13 participants |
| DRSP 3 mg/EE 30 µg (6 Cycles) | Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 6 | -2 (change in total dysmenorrhea scores) | 10 participants |
| DRSP 3 mg/EE 30 µg (6 Cycles) | Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 6 | -1 (change in total dysmenorrhea scores) | 12 participants |
| DRSP 3 mg/EE 30 µg (6 Cycles) | Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 6 | 0 (change in total dysmenorrhea scores) | 4 participants |
| DRSP 3 mg/EE 30 µg (6 Cycles) | Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 6 | 1 (change in total dysmenorrhea scores) | 2 participants |
| DRSP 3 mg/EE 30 µg (6 Cycles) | Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 6 | 2 (change in total dysmenorrhea scores) | 0 participants |
| DRSP 3 mg/EE 30 µg (6 Cycles) | Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 6 | 3 (change in total dysmenorrhea scores) | 0 participants |
| DRSP 3 mg/EE 30 µg (6 Cycles) | Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 6 | 4 (change in total dysmenorrhea scores) | 0 participants |
| DRSP 3 mg/EE 30 µg (6 Cycles) | Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 6 | 5 (change in total dysmenorrhea scores) | 0 participants |
Secondary
Number of Participants With a Total Pelvic Pain Score of 0 up to 6 at Times Other Than During Menstruation at Cycle 13
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.
Time frame: Up to Cycle 13 (364 days) with 28 days per cycle
Population: FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DRSP 3 mg/EE 20 µg (6 Cycles) | Number of Participants With a Total Pelvic Pain Score of 0 up to 6 at Times Other Than During Menstruation at Cycle 13 | 0 | 177 participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Number of Participants With a Total Pelvic Pain Score of 0 up to 6 at Times Other Than During Menstruation at Cycle 13 | 1 | 49 participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Number of Participants With a Total Pelvic Pain Score of 0 up to 6 at Times Other Than During Menstruation at Cycle 13 | 2 | 12 participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Number of Participants With a Total Pelvic Pain Score of 0 up to 6 at Times Other Than During Menstruation at Cycle 13 | 3 | 2 participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Number of Participants With a Total Pelvic Pain Score of 0 up to 6 at Times Other Than During Menstruation at Cycle 13 | 4 | 2 participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Number of Participants With a Total Pelvic Pain Score of 0 up to 6 at Times Other Than During Menstruation at Cycle 13 | 5 | 0 participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Number of Participants With a Total Pelvic Pain Score of 0 up to 6 at Times Other Than During Menstruation at Cycle 13 | 6 | 0 participants |
Secondary
Number of Participants With a Total Pelvic Pain Score of 0 up to 6 at Times Other Than During Menstruation at Cycle 6
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.
Time frame: Up to Cycle 6 (168 days) with 28 days per cycle
Population: FAS (Participants with data at Cycle 6)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DRSP 3 mg/EE 20 µg (6 Cycles) | Number of Participants With a Total Pelvic Pain Score of 0 up to 6 at Times Other Than During Menstruation at Cycle 6 | 3 | 2 participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Number of Participants With a Total Pelvic Pain Score of 0 up to 6 at Times Other Than During Menstruation at Cycle 6 | 4 | 2 participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Number of Participants With a Total Pelvic Pain Score of 0 up to 6 at Times Other Than During Menstruation at Cycle 6 | 0 | 202 participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Number of Participants With a Total Pelvic Pain Score of 0 up to 6 at Times Other Than During Menstruation at Cycle 6 | 5 | 2 participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Number of Participants With a Total Pelvic Pain Score of 0 up to 6 at Times Other Than During Menstruation at Cycle 6 | 2 | 11 participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Number of Participants With a Total Pelvic Pain Score of 0 up to 6 at Times Other Than During Menstruation at Cycle 6 | 6 | 0 participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Number of Participants With a Total Pelvic Pain Score of 0 up to 6 at Times Other Than During Menstruation at Cycle 6 | 1 | 52 participants |
| DRSP 3 mg/EE 30 µg (6 Cycles) | Number of Participants With a Total Pelvic Pain Score of 0 up to 6 at Times Other Than During Menstruation at Cycle 6 | 6 | 1 participants |
| DRSP 3 mg/EE 30 µg (6 Cycles) | Number of Participants With a Total Pelvic Pain Score of 0 up to 6 at Times Other Than During Menstruation at Cycle 6 | 0 | 34 participants |
| DRSP 3 mg/EE 30 µg (6 Cycles) | Number of Participants With a Total Pelvic Pain Score of 0 up to 6 at Times Other Than During Menstruation at Cycle 6 | 1 | 13 participants |
| DRSP 3 mg/EE 30 µg (6 Cycles) | Number of Participants With a Total Pelvic Pain Score of 0 up to 6 at Times Other Than During Menstruation at Cycle 6 | 2 | 4 participants |
| DRSP 3 mg/EE 30 µg (6 Cycles) | Number of Participants With a Total Pelvic Pain Score of 0 up to 6 at Times Other Than During Menstruation at Cycle 6 | 4 | 1 participants |
| DRSP 3 mg/EE 30 µg (6 Cycles) | Number of Participants With a Total Pelvic Pain Score of 0 up to 6 at Times Other Than During Menstruation at Cycle 6 | 5 | 0 participants |
| DRSP 3 mg/EE 30 µg (6 Cycles) | Number of Participants With a Total Pelvic Pain Score of 0 up to 6 at Times Other Than During Menstruation at Cycle 6 | 3 | 1 participants |
Secondary
Number of Participants With Intracyclic Bleeding From Cycle 1 to Cycle 13
Intracyclic bleedings were defined as bleedings while a participant takes active tablets.
Time frame: Up to Cycle 13 (364 days) with 28 days per cycle
Population: FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DRSP 3 mg/EE 20 µg (6 Cycles) | Number of Participants With Intracyclic Bleeding From Cycle 1 to Cycle 13 | Cycle 1 | 93 participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Number of Participants With Intracyclic Bleeding From Cycle 1 to Cycle 13 | Cycle 2 | 38 participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Number of Participants With Intracyclic Bleeding From Cycle 1 to Cycle 13 | Cycle 3 | 45 participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Number of Participants With Intracyclic Bleeding From Cycle 1 to Cycle 13 | Cycle 4 | 33 participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Number of Participants With Intracyclic Bleeding From Cycle 1 to Cycle 13 | Cycle 5 | 41 participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Number of Participants With Intracyclic Bleeding From Cycle 1 to Cycle 13 | Cycle 6 | 40 participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Number of Participants With Intracyclic Bleeding From Cycle 1 to Cycle 13 | Cycle 7 | 114 participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Number of Participants With Intracyclic Bleeding From Cycle 1 to Cycle 13 | Cycle 8 | 24 participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Number of Participants With Intracyclic Bleeding From Cycle 1 to Cycle 13 | Cycle 9 | 24 participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Number of Participants With Intracyclic Bleeding From Cycle 1 to Cycle 13 | Cycle 10 | 24 participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Number of Participants With Intracyclic Bleeding From Cycle 1 to Cycle 13 | Cycle 11 | 21 participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Number of Participants With Intracyclic Bleeding From Cycle 1 to Cycle 13 | Cycle 12 | 23 participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Number of Participants With Intracyclic Bleeding From Cycle 1 to Cycle 13 | Cycle 13 | 31 participants |
Secondary
Number of Participants With Intracyclic Bleeding From Cycle 1 to Cycle 6
Intracyclic bleedings were defined as bleedings while a participant takes active tablets.
Time frame: Up to Cycle 6 (168 days) with 28 days per cycle
Population: FAS (Participants with data at Cycle 6, values for Cycle 1 to Cycle 6 (Reference period 1 and Reference period 2) in the DRSP 3mg/EE 20 µg group were calculated based on incomplete data due to the cut-off date)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DRSP 3 mg/EE 20 µg (6 Cycles) | Number of Participants With Intracyclic Bleeding From Cycle 1 to Cycle 6 | Cycle 1 | 94 participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Number of Participants With Intracyclic Bleeding From Cycle 1 to Cycle 6 | Cycle 2 | 38 participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Number of Participants With Intracyclic Bleeding From Cycle 1 to Cycle 6 | Cycle 3 | 45 participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Number of Participants With Intracyclic Bleeding From Cycle 1 to Cycle 6 | Cycle 4 | 33 participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Number of Participants With Intracyclic Bleeding From Cycle 1 to Cycle 6 | Cycle 5 | 40 participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Number of Participants With Intracyclic Bleeding From Cycle 1 to Cycle 6 | Cycle 6 | 29 participants |
| DRSP 3 mg/EE 30 µg (6 Cycles) | Number of Participants With Intracyclic Bleeding From Cycle 1 to Cycle 6 | Cycle 5 | 5 participants |
| DRSP 3 mg/EE 30 µg (6 Cycles) | Number of Participants With Intracyclic Bleeding From Cycle 1 to Cycle 6 | Cycle 1 | 19 participants |
| DRSP 3 mg/EE 30 µg (6 Cycles) | Number of Participants With Intracyclic Bleeding From Cycle 1 to Cycle 6 | Cycle 4 | 3 participants |
| DRSP 3 mg/EE 30 µg (6 Cycles) | Number of Participants With Intracyclic Bleeding From Cycle 1 to Cycle 6 | Cycle 2 | 8 participants |
| DRSP 3 mg/EE 30 µg (6 Cycles) | Number of Participants With Intracyclic Bleeding From Cycle 1 to Cycle 6 | Cycle 6 | 4 participants |
| DRSP 3 mg/EE 30 µg (6 Cycles) | Number of Participants With Intracyclic Bleeding From Cycle 1 to Cycle 6 | Cycle 3 | 8 participants |
Secondary
Number of Participants With Withdrawal Bleeding From Cycle 1 to Cycle 13
Withdrawal bleedings were defined as bleedings while a participant takes placebo tablets.
Time frame: Up to Cycle 13 (364 days) with 28 days per cycle
Population: FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DRSP 3 mg/EE 20 µg (6 Cycles) | Number of Participants With Withdrawal Bleeding From Cycle 1 to Cycle 13 | Cycle 1 | 274 participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Number of Participants With Withdrawal Bleeding From Cycle 1 to Cycle 13 | Cycle 2 | 314 participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Number of Participants With Withdrawal Bleeding From Cycle 1 to Cycle 13 | Cycle 3 | 307 participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Number of Participants With Withdrawal Bleeding From Cycle 1 to Cycle 13 | Cycle 4 | 295 participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Number of Participants With Withdrawal Bleeding From Cycle 1 to Cycle 13 | Cycle 5 | 289 participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Number of Participants With Withdrawal Bleeding From Cycle 1 to Cycle 13 | Cycle 6 | 285 participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Number of Participants With Withdrawal Bleeding From Cycle 1 to Cycle 13 | Cycle 7 | 229 participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Number of Participants With Withdrawal Bleeding From Cycle 1 to Cycle 13 | Cycle 8 | 259 participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Number of Participants With Withdrawal Bleeding From Cycle 1 to Cycle 13 | Cycle 9 | 245 participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Number of Participants With Withdrawal Bleeding From Cycle 1 to Cycle 13 | Cycle 10 | 250 participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Number of Participants With Withdrawal Bleeding From Cycle 1 to Cycle 13 | Cycle 11 | 246 participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Number of Participants With Withdrawal Bleeding From Cycle 1 to Cycle 13 | Cycle 12 | 243 participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Number of Participants With Withdrawal Bleeding From Cycle 1 to Cycle 13 | Cycle 13 | 241 participants |
Secondary
Number of Participants With Withdrawal Bleeding From Cycle 1 to Cycle 6
Withdrawal bleedings were defined as bleedings while a participant takes placebo tablets.
Time frame: Up to Cycle 6 (168 days) with 28 days per cycle
Population: FAS (Participants with data at Cycle 6, values for Cycle 1 to Cycle 6 (Reference period 1 and Reference period 2) in the DRSP 3mg/EE 20 µg group were calculated based on incomplete data due to the cut-off date)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DRSP 3 mg/EE 20 µg (6 Cycles) | Number of Participants With Withdrawal Bleeding From Cycle 1 to Cycle 6 | Cycle 1 | 276 participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Number of Participants With Withdrawal Bleeding From Cycle 1 to Cycle 6 | Cycle 2 | 310 participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Number of Participants With Withdrawal Bleeding From Cycle 1 to Cycle 6 | Cycle 3 | 302 participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Number of Participants With Withdrawal Bleeding From Cycle 1 to Cycle 6 | Cycle 4 | 290 participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Number of Participants With Withdrawal Bleeding From Cycle 1 to Cycle 6 | Cycle 5 | 279 participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Number of Participants With Withdrawal Bleeding From Cycle 1 to Cycle 6 | Cycle 6 | 185 participants |
| DRSP 3 mg/EE 30 µg (6 Cycles) | Number of Participants With Withdrawal Bleeding From Cycle 1 to Cycle 6 | Cycle 5 | 54 participants |
| DRSP 3 mg/EE 30 µg (6 Cycles) | Number of Participants With Withdrawal Bleeding From Cycle 1 to Cycle 6 | Cycle 1 | 54 participants |
| DRSP 3 mg/EE 30 µg (6 Cycles) | Number of Participants With Withdrawal Bleeding From Cycle 1 to Cycle 6 | Cycle 4 | 54 participants |
| DRSP 3 mg/EE 30 µg (6 Cycles) | Number of Participants With Withdrawal Bleeding From Cycle 1 to Cycle 6 | Cycle 2 | 57 participants |
| DRSP 3 mg/EE 30 µg (6 Cycles) | Number of Participants With Withdrawal Bleeding From Cycle 1 to Cycle 6 | Cycle 6 | 52 participants |
| DRSP 3 mg/EE 30 µg (6 Cycles) | Number of Participants With Withdrawal Bleeding From Cycle 1 to Cycle 6 | Cycle 3 | 58 participants |
Secondary
Percentage of Participants With Non-heavy Intracyclic Bleeding From Cycle 1 to Cycle 13
Non-heavy bleeding was defined as those other than heavy bleeding (i.e. spotting, light, or normal bleeding).
Time frame: Up to Cycle 13 (364 days) with 28 days per cycle
Population: FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DRSP 3 mg/EE 20 µg (6 Cycles) | Percentage of Participants With Non-heavy Intracyclic Bleeding From Cycle 1 to Cycle 13 | Cycle 1 | 90.3 Percentage of participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Percentage of Participants With Non-heavy Intracyclic Bleeding From Cycle 1 to Cycle 13 | Cycle 2 | 97.4 Percentage of participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Percentage of Participants With Non-heavy Intracyclic Bleeding From Cycle 1 to Cycle 13 | Cycle 3 | 91.1 Percentage of participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Percentage of Participants With Non-heavy Intracyclic Bleeding From Cycle 1 to Cycle 13 | Cycle 4 | 87.9 Percentage of participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Percentage of Participants With Non-heavy Intracyclic Bleeding From Cycle 1 to Cycle 13 | Cycle 5 | 87.8 Percentage of participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Percentage of Participants With Non-heavy Intracyclic Bleeding From Cycle 1 to Cycle 13 | Cycle 6 | 92.5 Percentage of participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Percentage of Participants With Non-heavy Intracyclic Bleeding From Cycle 1 to Cycle 13 | Cycle 7 | 90.4 Percentage of participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Percentage of Participants With Non-heavy Intracyclic Bleeding From Cycle 1 to Cycle 13 | Cycle 8 | 100.0 Percentage of participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Percentage of Participants With Non-heavy Intracyclic Bleeding From Cycle 1 to Cycle 13 | Cycle 9 | 87.5 Percentage of participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Percentage of Participants With Non-heavy Intracyclic Bleeding From Cycle 1 to Cycle 13 | Cycle 10 | 100.0 Percentage of participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Percentage of Participants With Non-heavy Intracyclic Bleeding From Cycle 1 to Cycle 13 | Cycle 11 | 100.0 Percentage of participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Percentage of Participants With Non-heavy Intracyclic Bleeding From Cycle 1 to Cycle 13 | Cycle 12 | 100.0 Percentage of participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Percentage of Participants With Non-heavy Intracyclic Bleeding From Cycle 1 to Cycle 13 | Cycle 13 | 90.3 Percentage of participants |
Secondary
Percentage of Participants With Non-heavy Intracyclic Bleeding From Cycle 1 to Cycle 6
Non-heavy bleeding was defined as those other than heavy bleeding (i.e. spotting, light, or normal bleeding).
Time frame: Up to Cycle 6 (168 days) with 28 days per cycle
Population: FAS (Participants with data at Cycle 6, values for Cycle 1 to Cycle 6 (Reference period 1 and Reference period 2) in the DRSP 3mg/EE 20 µg group were calculated based on incomplete data due to the cut-off date)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DRSP 3 mg/EE 20 µg (6 Cycles) | Percentage of Participants With Non-heavy Intracyclic Bleeding From Cycle 1 to Cycle 6 | Cycle 1 | 90.3 Percentage of participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Percentage of Participants With Non-heavy Intracyclic Bleeding From Cycle 1 to Cycle 6 | Cycle 2 | 97.4 Percentage of participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Percentage of Participants With Non-heavy Intracyclic Bleeding From Cycle 1 to Cycle 6 | Cycle 3 | 91.1 Percentage of participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Percentage of Participants With Non-heavy Intracyclic Bleeding From Cycle 1 to Cycle 6 | Cycle 4 | 87.9 Percentage of participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Percentage of Participants With Non-heavy Intracyclic Bleeding From Cycle 1 to Cycle 6 | Cycle 5 | 87.8 Percentage of participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Percentage of Participants With Non-heavy Intracyclic Bleeding From Cycle 1 to Cycle 6 | Cycle 6 | 92.5 Percentage of participants |
| DRSP 3 mg/EE 30 µg (6 Cycles) | Percentage of Participants With Non-heavy Intracyclic Bleeding From Cycle 1 to Cycle 6 | Cycle 5 | 80.0 Percentage of participants |
| DRSP 3 mg/EE 30 µg (6 Cycles) | Percentage of Participants With Non-heavy Intracyclic Bleeding From Cycle 1 to Cycle 6 | Cycle 1 | 89.5 Percentage of participants |
| DRSP 3 mg/EE 30 µg (6 Cycles) | Percentage of Participants With Non-heavy Intracyclic Bleeding From Cycle 1 to Cycle 6 | Cycle 4 | 100.0 Percentage of participants |
| DRSP 3 mg/EE 30 µg (6 Cycles) | Percentage of Participants With Non-heavy Intracyclic Bleeding From Cycle 1 to Cycle 6 | Cycle 2 | 100.0 Percentage of participants |
| DRSP 3 mg/EE 30 µg (6 Cycles) | Percentage of Participants With Non-heavy Intracyclic Bleeding From Cycle 1 to Cycle 6 | Cycle 6 | 100.0 Percentage of participants |
| DRSP 3 mg/EE 30 µg (6 Cycles) | Percentage of Participants With Non-heavy Intracyclic Bleeding From Cycle 1 to Cycle 6 | Cycle 3 | 100.0 Percentage of participants |
Secondary
Percentage of Participants With Non-heavy Withdrawal Bleeding From Cycle 1 to Cycle 13
Non-heavy bleeding was defined as those other than heavy bleeding (i.e. spotting, light, or normal bleeding).
Time frame: Up to Cycle 13 (364 days) with 28 days per cycle
Population: FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DRSP 3 mg/EE 20 µg (6 Cycles) | Percentage of Participants With Non-heavy Withdrawal Bleeding From Cycle 1 to Cycle 13 | Cycle 13 | 93.8 Percentage of participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Percentage of Participants With Non-heavy Withdrawal Bleeding From Cycle 1 to Cycle 13 | Cycle 1 | 90.1 Percentage of participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Percentage of Participants With Non-heavy Withdrawal Bleeding From Cycle 1 to Cycle 13 | Cycle 2 | 90.8 Percentage of participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Percentage of Participants With Non-heavy Withdrawal Bleeding From Cycle 1 to Cycle 13 | Cycle 3 | 91.2 Percentage of participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Percentage of Participants With Non-heavy Withdrawal Bleeding From Cycle 1 to Cycle 13 | Cycle 4 | 92.2 Percentage of participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Percentage of Participants With Non-heavy Withdrawal Bleeding From Cycle 1 to Cycle 13 | Cycle 5 | 92.7 Percentage of participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Percentage of Participants With Non-heavy Withdrawal Bleeding From Cycle 1 to Cycle 13 | Cycle 6 | 90.9 Percentage of participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Percentage of Participants With Non-heavy Withdrawal Bleeding From Cycle 1 to Cycle 13 | Cycle 7 | 91.3 Percentage of participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Percentage of Participants With Non-heavy Withdrawal Bleeding From Cycle 1 to Cycle 13 | Cycle 8 | 91.1 Percentage of participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Percentage of Participants With Non-heavy Withdrawal Bleeding From Cycle 1 to Cycle 13 | Cycle 9 | 91.0 Percentage of participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Percentage of Participants With Non-heavy Withdrawal Bleeding From Cycle 1 to Cycle 13 | Cycle 10 | 90.8 Percentage of participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Percentage of Participants With Non-heavy Withdrawal Bleeding From Cycle 1 to Cycle 13 | Cycle 11 | 91.9 Percentage of participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Percentage of Participants With Non-heavy Withdrawal Bleeding From Cycle 1 to Cycle 13 | Cycle 12 | 93.8 Percentage of participants |
Secondary
Percentage of Participants With Non-heavy Withdrawal Bleeding From Cycle 1 to Cycle 6
Non-heavy bleeding was defined as those other than heavy bleeding (i.e. spotting, light, or normal bleeding).
Time frame: Up to Cycle 6 (168 days) with 28 days per cycle
Population: FAS (Participants with data at Cycle 6, values for Cycle 1 to Cycle 6 (Reference period 1 and Reference period 2) in the DRSP 3mg/EE 20 µg group were calculated based on incomplete data due to the cut-off date)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DRSP 3 mg/EE 20 µg (6 Cycles) | Percentage of Participants With Non-heavy Withdrawal Bleeding From Cycle 1 to Cycle 6 | Cycle 1 | 90.1 Percentage of participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Percentage of Participants With Non-heavy Withdrawal Bleeding From Cycle 1 to Cycle 6 | Cycle 2 | 90.8 Percentage of participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Percentage of Participants With Non-heavy Withdrawal Bleeding From Cycle 1 to Cycle 6 | Cycle 3 | 91.2 Percentage of participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Percentage of Participants With Non-heavy Withdrawal Bleeding From Cycle 1 to Cycle 6 | Cycle 4 | 92.2 Percentage of participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Percentage of Participants With Non-heavy Withdrawal Bleeding From Cycle 1 to Cycle 6 | Cycle 5 | 92.7 Percentage of participants |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Percentage of Participants With Non-heavy Withdrawal Bleeding From Cycle 1 to Cycle 6 | Cycle 6 | 90.9 Percentage of participants |
| DRSP 3 mg/EE 30 µg (6 Cycles) | Percentage of Participants With Non-heavy Withdrawal Bleeding From Cycle 1 to Cycle 6 | Cycle 5 | 88.9 Percentage of participants |
| DRSP 3 mg/EE 30 µg (6 Cycles) | Percentage of Participants With Non-heavy Withdrawal Bleeding From Cycle 1 to Cycle 6 | Cycle 1 | 87.0 Percentage of participants |
| DRSP 3 mg/EE 30 µg (6 Cycles) | Percentage of Participants With Non-heavy Withdrawal Bleeding From Cycle 1 to Cycle 6 | Cycle 4 | 92.6 Percentage of participants |
| DRSP 3 mg/EE 30 µg (6 Cycles) | Percentage of Participants With Non-heavy Withdrawal Bleeding From Cycle 1 to Cycle 6 | Cycle 2 | 94.7 Percentage of participants |
| DRSP 3 mg/EE 30 µg (6 Cycles) | Percentage of Participants With Non-heavy Withdrawal Bleeding From Cycle 1 to Cycle 6 | Cycle 6 | 88.5 Percentage of participants |
| DRSP 3 mg/EE 30 µg (6 Cycles) | Percentage of Participants With Non-heavy Withdrawal Bleeding From Cycle 1 to Cycle 6 | Cycle 3 | 87.9 Percentage of participants |
Post Hoc
Change in Total Dysmenorrhea Score at Final Evaluation in Subgroups (1): From Baseline to Cycle 13
Total dysmenorrhea 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.
Time frame: Baseline and up to Cycle 13 (364 days) with 28 days per cycle
Population: FAS (note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DRSP 3 mg/EE 20 µg (6 Cycles) | Change in Total Dysmenorrhea Score at Final Evaluation in Subgroups (1): From Baseline to Cycle 13 | age: < 30 years | -2.5 scores on a scale | Standard Deviation 1.67 |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Change in Total Dysmenorrhea Score at Final Evaluation in Subgroups (1): From Baseline to Cycle 13 | age: >= 30 years | -2.4 scores on a scale | Standard Deviation 1.7 |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Change in Total Dysmenorrhea Score at Final Evaluation in Subgroups (1): From Baseline to Cycle 13 | weight: < 50 kg | -2.1 scores on a scale | Standard Deviation 1.68 |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Change in Total Dysmenorrhea Score at Final Evaluation in Subgroups (1): From Baseline to Cycle 13 | weight: >= 50kg | -2.7 scores on a scale | Standard Deviation 1.65 |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Change in Total Dysmenorrhea Score at Final Evaluation in Subgroups (1): From Baseline to Cycle 13 | functional dysmenorrhea | -2.6 scores on a scale | Standard Deviation 1.7 |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Change in Total Dysmenorrhea Score at Final Evaluation in Subgroups (1): From Baseline to Cycle 13 | organic dysmenorrhea | -2.1 scores on a scale | Standard Deviation 1.59 |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Change in Total Dysmenorrhea Score at Final Evaluation in Subgroups (1): From Baseline to Cycle 13 | with medical surgical history | -2.5 scores on a scale | Standard Deviation 1.72 |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Change in Total Dysmenorrhea Score at Final Evaluation in Subgroups (1): From Baseline to Cycle 13 | without medical surgical history | -2.5 scores on a scale | Standard Deviation 1.64 |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Change in Total Dysmenorrhea Score at Final Evaluation in Subgroups (1): From Baseline to Cycle 13 | with previous medication | -2.5 scores on a scale | Standard Deviation 1.69 |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Change in Total Dysmenorrhea Score at Final Evaluation in Subgroups (1): From Baseline to Cycle 13 | with pregnancy history | -2.1 scores on a scale | Standard Deviation 1.75 |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Change in Total Dysmenorrhea Score at Final Evaluation in Subgroups (1): From Baseline to Cycle 13 | with birth history | -1.9 scores on a scale | Standard Deviation 1.76 |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Change in Total Dysmenorrhea Score at Final Evaluation in Subgroups (1): From Baseline to Cycle 13 | total dysmenorrhea score at baseline 3/4 | -2.0 scores on a scale | Standard Deviation 1.48 |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Change in Total Dysmenorrhea Score at Final Evaluation in Subgroups (1): From Baseline to Cycle 13 | total dysmenorrhea score at baseline 5/6 | -3.2 scores on a scale | Standard Deviation 1.75 |
Post Hoc
Change in Total Dysmenorrhea Score at Final Evaluation in Subgroups (1): From Baseline to Cycle 6
Total dysmenorrhea 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.
Time frame: Baseline and up to Cycle 6 (168 days) with 28 days per cycle
Population: FAS
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DRSP 3 mg/EE 20 µg (6 Cycles) | Change in Total Dysmenorrhea Score at Final Evaluation in Subgroups (1): From Baseline to Cycle 6 | weight: < 50 kg | -2.0 scores on a scale | Standard Deviation 1.58 |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Change in Total Dysmenorrhea Score at Final Evaluation in Subgroups (1): From Baseline to Cycle 6 | without medical surgical history | -2.4 scores on a scale | Standard Deviation 1.54 |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Change in Total Dysmenorrhea Score at Final Evaluation in Subgroups (1): From Baseline to Cycle 6 | functional dysmenorrhea | -2.4 scores on a scale | Standard Deviation 1.64 |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Change in Total Dysmenorrhea Score at Final Evaluation in Subgroups (1): From Baseline to Cycle 6 | with previous medication | -2.3 scores on a scale | Standard Deviation 1.61 |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Change in Total Dysmenorrhea Score at Final Evaluation in Subgroups (1): From Baseline to Cycle 6 | age: >= 30 years | -2.2 scores on a scale | Standard Deviation 1.52 |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Change in Total Dysmenorrhea Score at Final Evaluation in Subgroups (1): From Baseline to Cycle 6 | with pregnancy history | -2.2 scores on a scale | Standard Deviation 1.67 |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Change in Total Dysmenorrhea Score at Final Evaluation in Subgroups (1): From Baseline to Cycle 6 | organic dysmenorrhea | -2.0 scores on a scale | Standard Deviation 1.45 |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Change in Total Dysmenorrhea Score at Final Evaluation in Subgroups (1): From Baseline to Cycle 6 | with birth history | -2.0 scores on a scale | Standard Deviation 1.71 |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Change in Total Dysmenorrhea Score at Final Evaluation in Subgroups (1): From Baseline to Cycle 6 | weight: >= 50kg | -2.5 scores on a scale | Standard Deviation 1.61 |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Change in Total Dysmenorrhea Score at Final Evaluation in Subgroups (1): From Baseline to Cycle 6 | total dysmenorrhea score at baseline 3/4 | -1.9 scores on a scale | Standard Deviation 1.37 |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Change in Total Dysmenorrhea Score at Final Evaluation in Subgroups (1): From Baseline to Cycle 6 | with medical surgical history | -2.3 scores on a scale | Standard Deviation 1.61 |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Change in Total Dysmenorrhea Score at Final Evaluation in Subgroups (1): From Baseline to Cycle 6 | total dysmenorrhea score at baseline 5/6 | -3.0 scores on a scale | Standard Deviation 1.73 |
| DRSP 3 mg/EE 20 µg (6 Cycles) | Change in Total Dysmenorrhea Score at Final Evaluation in Subgroups (1): From Baseline to Cycle 6 | age: < 30 years | -2.4 scores on a scale | Standard Deviation 1.68 |
| DRSP 3 mg/EE 30 µg (6 Cycles) | Change in Total Dysmenorrhea Score at Final Evaluation in Subgroups (1): From Baseline to Cycle 6 | total dysmenorrhea score at baseline 5/6 | -2.6 scores on a scale | Standard Deviation 2.04 |
| DRSP 3 mg/EE 30 µg (6 Cycles) | Change in Total Dysmenorrhea Score at Final Evaluation in Subgroups (1): From Baseline to Cycle 6 | age: < 30 years | -2.2 scores on a scale | Standard Deviation 1.64 |
| DRSP 3 mg/EE 30 µg (6 Cycles) | Change in Total Dysmenorrhea Score at Final Evaluation in Subgroups (1): From Baseline to Cycle 6 | age: >= 30 years | -2.1 scores on a scale | Standard Deviation 1.69 |
| DRSP 3 mg/EE 30 µg (6 Cycles) | Change in Total Dysmenorrhea Score at Final Evaluation in Subgroups (1): From Baseline to Cycle 6 | weight: < 50 kg | -2.3 scores on a scale | Standard Deviation 1.76 |
| DRSP 3 mg/EE 30 µg (6 Cycles) | Change in Total Dysmenorrhea Score at Final Evaluation in Subgroups (1): From Baseline to Cycle 6 | weight: >= 50kg | -2.0 scores on a scale | Standard Deviation 1.6 |
| DRSP 3 mg/EE 30 µg (6 Cycles) | Change in Total Dysmenorrhea Score at Final Evaluation in Subgroups (1): From Baseline to Cycle 6 | functional dysmenorrhea | -2.3 scores on a scale | Standard Deviation 1.54 |
| DRSP 3 mg/EE 30 µg (6 Cycles) | Change in Total Dysmenorrhea Score at Final Evaluation in Subgroups (1): From Baseline to Cycle 6 | organic dysmenorrhea | -1.3 scores on a scale | Standard Deviation 1.91 |
| DRSP 3 mg/EE 30 µg (6 Cycles) | Change in Total Dysmenorrhea Score at Final Evaluation in Subgroups (1): From Baseline to Cycle 6 | with medical surgical history | -2.0 scores on a scale | Standard Deviation 1.69 |
| DRSP 3 mg/EE 30 µg (6 Cycles) | Change in Total Dysmenorrhea Score at Final Evaluation in Subgroups (1): From Baseline to Cycle 6 | without medical surgical history | -2.4 scores on a scale | Standard Deviation 1.6 |
| DRSP 3 mg/EE 30 µg (6 Cycles) | Change in Total Dysmenorrhea Score at Final Evaluation in Subgroups (1): From Baseline to Cycle 6 | with previous medication | -2.1 scores on a scale | Standard Deviation 1.66 |
| DRSP 3 mg/EE 30 µg (6 Cycles) | Change in Total Dysmenorrhea Score at Final Evaluation in Subgroups (1): From Baseline to Cycle 6 | with pregnancy history | -2.1 scores on a scale | Standard Deviation 1.68 |
| DRSP 3 mg/EE 30 µg (6 Cycles) | Change in Total Dysmenorrhea Score at Final Evaluation in Subgroups (1): From Baseline to Cycle 6 | with birth history | -2.4 scores on a scale | Standard Deviation 1.83 |
| DRSP 3 mg/EE 30 µg (6 Cycles) | Change in Total Dysmenorrhea Score at Final Evaluation in Subgroups (1): From Baseline to Cycle 6 | total dysmenorrhea score at baseline 3/4 | -1.9 scores on a scale | Standard Deviation 1.37 |