Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 310283 | Other Identifier | Company Internal |
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The purpose of this study is to investigate efficacy of drospirenone for dysmenorrhea.
Not provided
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DRSP 1 mg/EE 20 μg | Experimental | 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 | Experimental | 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 | Experimental | 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 | Placebo Comparator | 1 tablet per day placebo for 28 days in each 28-day cycle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SH T04740B | Drug | Drospirenone 1mg/EE 20µg (ß-CDC) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Total Dysmenorrheal Score at Final Evaluation | 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.) | Baseline and up to 4 Cycles (28 days per cycle) |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Total Dysmenorrheal Score at Cycle 1 up to Cycle 4 | 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. | Baseline and up to 4 Cycles (28 days per cycle) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maebashi | Gunma | 371-0024 | Japan | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Momoeda M, et al. Treatment of Functional and Organic Dysmenorrhea - Investigation of the Efficacy and Safety of Drospirenone/Ethinylestradiol Combination Tablet (YAZ). Sanka to Fujinka (Obstetrics and Gynecology), 2010: 77 (8) 977-88 (in Japanese) | ||
| 37523477 | Derived | Schroll JB, Black AY, Farquhar C, Chen I. Combined oral contraceptive pill for primary dysmenorrhoea. Cochrane Database Syst Rev. 2023 Jul 31;7(7):CD002120. doi: 10.1002/14651858.CD002120.pub4. |
Not provided
Not provided
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.
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Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| FG002 | 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 |
| FG003 | Placebo | 1 tablet per day placebo for 28 days in each 28-day cycle |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | DRSP 2 mg/EE 20 μg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Total Dysmenorrheal Score at Final Evaluation | 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.) | FAS | Posted | Mean | Standard Deviation | scores on a scale | Baseline and up to 4 Cycles (28 days per cycle) |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendicitis | Infections and infestations | MedDRA (11.1) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA (11.1) | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | BAYER | clinical-trials-contact@bayerhealthcare.com |
Not provided
| ID | Term |
|---|---|
| D004412 | Dysmenorrhea |
| ID | Term |
|---|---|
| D008599 | Menstruation Disturbances |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017699 | Pelvic Pain |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| SH T00186DF |
| Drug |
Drospirenone 3 mg/EE 20µg (ß-CDC) |
|
| SH T04740F | Drug | Drospirenone 2 mg/EE 20µg (ß-CDC) |
|
| Placebo | Drug | Placebo |
|
| Number of Participants With Severity of Lower Abdominal Pain During Menstruation 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). | Cycle 4 (28 days per cycle) |
| Number of Participants With Severity of Low Back Pain During Menstruation 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). | Cycle 4 (28 days per cycle) |
| Number of Participants With Severity of Headache During Menstruation 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). | Cycle 4 (28 days per cycle) |
| Number of Participants With Severity of Nausea or Vomiting During Menstruation 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). | Cycle 4 (28 days per cycle) |
| Number of Participants With Total Pelvic Pain Score at Times Other Than During Menstruation 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. | Cycle 4 (28 days per cycle) |
| Change From Baseline in Visual Analogue Scale (VAS) for Dysmenorrhea at Times Other Than During Menstruation 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). | From baseline up to Cycle 4 (28 days per cycle) |
| Visual Analogue Scale (VAS) for Pelvic Pain at Times Other Than During Menstruation 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). | Cycle 4 (28 days per cycle) |
| Change From Baseline in Endometrial Thickness After 4-cycle Treatment | 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. | From baseline to Cycle 4 (28 days per cycle) |
| Number of Bleeding / Spotting Episodes | 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. | For the first 90 days |
| Number of Bleeding / Spotting Days | 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. | For the first 90 days |
| Participants With Withdrawal Bleeding | Withdrawal bleedings were defined as bleedings while a participant takes placebo tablets. | At Cycle 4 (28 days per cycle) |
| Participants With Intracyclic Bleeding | Intracyclic bleedings were defined as bleedings while a participant takes active drugs. | At Cycle 4 (28 days per cycle) |
| Participants With Non-heavy Intracyclic Bleeding | Non-heavy bleedings were defined as those other than heavy bleeding (less or normal bleeding). | At Cycle 4 (28 days per cycle) |
| Participants With Non-heavy Withdrawal Bleeding | Non-heavy bleedings were defined as those other than heavy bleeding (less or normal bleeding). | At Cycle 4 (28 dyas per cycle) |
| Change From Baseline in Serum Carbohydrate Antigen-125 (CA125) After 4-cycle Treatment | CA125 is a laboratory parameter giving an indication of having tumor, whose elevated levels that were defined by a lab suggest a potential tumor. | From baseline to Cycle 4 (28 days per cycle) |
| Change From Baseline in Serum C-reactive Protein (CRP) After 4-cycle Treatment | CRP is a laboratory parameter giving an indication of inflammation, whose elevated levels that were defined by a lab suggest a potential inflammation. | From baseline to Cycle 4 (28 days per cycle) |
| Change From Baseline in Serum Estradiol Level After 4-cycle Treatment | Estradiol is a predominant sex hormone that presents in female. | From baseline to Cycle 4 (28 days per cycle) |
| Change From Baseline in Serum Progesterone Level at Cycle 4 | Progesterone is a steroid hormone involving in the female menstrual cycle, pregnancy, etc. | From baseline to Cycle 4 (28 days per cycle) |
| Kobe |
| Hyōgo |
| 650-0021 |
| Japan |
| Nishinomiya | Hyōgo | 663-8204 | Japan |
| Yokohama | Kanagawa | 231-0861 | Japan |
| Kyoto | Kyoto | 612-0064 | Japan |
| Sendai | Miyagi | 981-0933 | Japan |
| Osaka | Osaka | 530-0013 | Japan |
| Chuo-ku | Tokyo | 104-0061 | Japan |
| Hachiōji | Tokyo | 192-0046 | Japan |
| Setagaya-ku | Tokyo | 156-0042 | Japan |
| Setagaya-ku | Tokyo | 157-0066 | Japan |
| Toshima-ku | Tokyo | 171-0021 | Japan |
| Lost to Follow-up |
|
| Pregnancy |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Never dispensed |
|
| Study drug not taken |
|
| Partially missing diary |
|
| Other (moving etc) |
|
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
| BG002 | 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 |
| BG003 | Placebo | 1 tablet per day placebo for 28 days in each 28-day cycle |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Gender | Count of Participants | Participants |
|
| Diagnosis type | Number | participants |
|
| Details of organic dysmenorrhea | Not all participants had organic dysmenorrhea. Some of participants were diagnosed as having a multiple type of organic dysmenorrhea. | Number | participants |
|
| Average length of menstrual cycle | Mean | Full Range | days |
|
| Body mass index (BMI) | Mean | Full Range | kg/m^2 |
|
| OG001 |
| 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 |
| OG002 | 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 |
| OG003 | Placebo | 1 tablet per day placebo for 28 days in each 28-day cycle |
|
|
|
| Secondary | Change From Baseline in Total Dysmenorrheal Score at Cycle 1 up to Cycle 4 | 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. | FAS | Posted | Mean | Standard Deviation | scores on a scale | Baseline and up to 4 Cycles (28 days per cycle) |
|
|
|
|
| Secondary | Number of Participants With Severity of Lower Abdominal Pain During Menstruation 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). | FAS (Participants with data at Cycle 4) | Posted | Number | participants | Cycle 4 (28 days per cycle) |
|
|
|
| Secondary | Number of Participants With Severity of Low Back Pain During Menstruation 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). | FAS (Participants with data at Cycle 4) | Posted | Number | participants | Cycle 4 (28 days per cycle) |
|
|
|
| Secondary | Number of Participants With Severity of Headache During Menstruation 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). | FAS (Participants with data at Cycle 4) | Posted | Number | participants | Cycle 4 (28 days per cycle) |
|
|
|
| Secondary | Number of Participants With Severity of Nausea or Vomiting During Menstruation 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). | FAS (Participants with data at Cycle 4) | Posted | Number | participants | Cycle 4 (28 days per cycle) |
|
|
|
| Secondary | Number of Participants With Total Pelvic Pain Score at Times Other Than During Menstruation 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. | FAS (Participants with data at Cycle 4) | Posted | Number | participants | Cycle 4 (28 days per cycle) |
|
|
|
| Secondary | Change From Baseline in Visual Analogue Scale (VAS) for Dysmenorrhea at Times Other Than During Menstruation 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). | FAS (Participants with data at Cycle 4) | Posted | Mean | Standard Deviation | scores on a scale | From baseline up to Cycle 4 (28 days per cycle) |
|
|
|
| Secondary | Visual Analogue Scale (VAS) for Pelvic Pain at Times Other Than During Menstruation 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). | FAS (Participants with data at Cycle 4) | Posted | Mean | Standard Deviation | scores on a scale | Cycle 4 (28 days per cycle) |
|
|
|
| Secondary | Change From Baseline in Endometrial Thickness After 4-cycle Treatment | 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. | FAS (Participants with data at Cycle 4) | Posted | Mean | Standard Deviation | mm | From baseline to Cycle 4 (28 days per cycle) |
|
|
|
| Secondary | Number of Bleeding / Spotting Episodes | 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. | FAS (Participants with the defined data) | Posted | Mean | Standard Deviation | number of episodes | For the first 90 days |
|
|
|
| Secondary | Number of Bleeding / Spotting Days | 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. | FAS (Participants with the defined data) | Posted | Mean | Standard Deviation | days | For the first 90 days |
|
|
|
| Secondary | Participants With Withdrawal Bleeding | Withdrawal bleedings were defined as bleedings while a participant takes placebo tablets. | FAS (Participants with data at Cycle 4) | Posted | Number | participants | At Cycle 4 (28 days per cycle) |
|
|
|
| Secondary | Participants With Intracyclic Bleeding | Intracyclic bleedings were defined as bleedings while a participant takes active drugs. | FAS (Participants with data at Cycle 4) | Posted | Number | participants | At Cycle 4 (28 days per cycle) |
|
|
|
| Secondary | Participants With Non-heavy Intracyclic Bleeding | Non-heavy bleedings were defined as those other than heavy bleeding (less or normal bleeding). | FAS (Participants with data at Cycle 4) | Posted | Number | participants | At Cycle 4 (28 days per cycle) |
|
|
|
| Secondary | Participants With Non-heavy Withdrawal Bleeding | Non-heavy bleedings were defined as those other than heavy bleeding (less or normal bleeding). | FAS (Participants with data at Cycle 4) | Posted | Number | participants | At Cycle 4 (28 dyas per cycle) |
|
|
|
| Secondary | Change From Baseline in Serum Carbohydrate Antigen-125 (CA125) After 4-cycle Treatment | CA125 is a laboratory parameter giving an indication of having tumor, whose elevated levels that were defined by a lab suggest a potential tumor. | FAS (Participants with data at Cycle 4) | Posted | Mean | Full Range | Units/L | From baseline to Cycle 4 (28 days per cycle) |
|
|
|
| Secondary | Change From Baseline in Serum C-reactive Protein (CRP) After 4-cycle Treatment | CRP is a laboratory parameter giving an indication of inflammation, whose elevated levels that were defined by a lab suggest a potential inflammation. | FAS (Participants with data at Cycle 4) | Posted | Mean | Full Range | mg/dL | From baseline to Cycle 4 (28 days per cycle) |
|
|
|
| Secondary | Change From Baseline in Serum Estradiol Level After 4-cycle Treatment | Estradiol is a predominant sex hormone that presents in female. | FAS (Participants with data at Cycle 4) | Posted | Mean | Full Range | pg/mL | From baseline to Cycle 4 (28 days per cycle) |
|
|
|
| Secondary | Change From Baseline in Serum Progesterone Level at Cycle 4 | Progesterone is a steroid hormone involving in the female menstrual cycle, pregnancy, etc. | FAS (Participants with data at Cycle 4) | Posted | Mean | Full Range | ng/mL | From baseline to Cycle 4 (28 days per cycle) |
|
|
|
| Post-Hoc | Change From Baseline for Total Pelvic Pain Score at Times Other Than During Menstruation 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. | FAS (Participants with data at Cycle 4) | Posted | Mean | Standard Deviation | scores on a scale | From baseline to Cycle 4(28 days per cycle) |
|
|
|
| Post-Hoc | Change From Baseline in Total Dysmenorrheal Score at Final Evaluation in Subgroups (1) | 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.) | FAS | Posted | Mean | Standard Deviation | scores on a scale | Baseline and up to Cycle 4 (28 days per cycle) |
|
|
|
| Post-Hoc | Change From Baseline in Total Dysmenorrheal Score at Final Evaluation in Subgroups (2) | 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.) | FAS | Posted | Mean | Standard Deviation | scores on a scale | Baseline and up to 4 Cycles (28 days per cycle) |
|
|
|
| Post-Hoc | Change From Baseline in Total Dysmenorrheal Score at Final Evaluation in Patients Without Previous Medication | 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.) | 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. | Posted | Mean | Standard Deviation | scores on a scale | Baseline and up to 4 Cycles (28 days per cycle) |
|
|
|
| 1 |
| 62 |
| 56 |
| 62 |
| EG001 | 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 | 2 | 63 | 58 | 63 |
| EG002 | 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 | 0 | 62 | 60 | 62 |
| EG003 | Placebo | 1 tablet per day placebo for 28 days in each 28-day cycle | 1 | 62 | 53 | 62 |
| Henoch-Schonlein purpura | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Lipoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.1) | Non-systematic Assessment |
|
| Cervix carcinoma stage 0 | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.1) | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Blood triglycerides increased | Investigations | MedDRA (11.1) | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Malaise | General disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Metrorrhagia | Reproductive system and breast disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (11.1) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Prothrombin time shortened | Investigations | MedDRA (11.1) | Non-systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Breast discomfort | Reproductive system and breast disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA (11.1) | Non-systematic Assessment |
|
| Genital haemorrhage | Reproductive system and breast disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Coagulation test abnormal | Investigations | MedDRA (11.1) | Non-systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA (11.1) | Non-systematic Assessment |
|
Sponsor will confirm the contents before disclosure.
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| Cycle 2 |
|
| Cycle 3 |
|
| Cycle 4 |
|
| t-test, 1 sided |
| <0.001 |
| Mean Difference (Final Values) |
| -1.34 |
| Standard Error of the Mean |
| 0.306 |
| 95 |
| -1.95 |
| -0.73 |
| No |
| Superiority or Other |
| t-test, 1 sided | <0.001 | Mean Difference (Final Values) | -1.53 | Standard Error of the Mean | 0.317 | 95 | -2.16 | -0.90 | No | Superiority or Other |
| mild |
|
| moderate |
|
| severe |
|
| mild |
|
| moderate |
|
| severe |
|
| mild |
|
| moderate |
|
| severe |
|
| mild |
|
| moderate |
|
| severe |
|
| 1 |
|
| 2 |
|
| 3 |
|
| 4 |
|
| 5 |
|
| 6 |
|
| bleeding only |
|
| spotting only |
|
| bleeding only |
|
| spotting only |
|
| age: >= 30 years |
|
| weight: < 50 kg |
|
| weight: >= 50kg |
|
| functional dysmenorrhea |
|
| organic dysmenorrhea |
|
| with medical surgical history |
|
| without medical surgical history |
|
| with pregnancy history |
|
| without pregnancy history |
|
| with birth history |
|
| without birth history |
|
| total dysmenorrheal score at baseline: 3 or 4 |
|
| total dysmenorrheal score at baseline: 5 or 6 |
|