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| ID | Type | Description | Link |
|---|---|---|---|
| 311962 | Other Identifier | Company Internal |
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The purpose of this study is to evaluate the efficacy and safety of YAZ compared to placebo in the treatment of symptoms related to Premenstrual Dysphoric Disorder (PMDD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
| |
| Arm 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EE20/DRSP(YAZ, BAY86-5300) | Drug | 20 μg ethinylestradiol, 3mg drospirenone, tablet, orally, opd |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The difference in DRSP scale scores for the first 21 items, comparing average scores from the last 5 days before menses of the 3rd cycle in the treatment phase to average scores from the last 5 days before menses of the 2 run in cycles | 3 cycles (1 cycle= 28 days) |
| Measure | Description | Time Frame |
|---|---|---|
| The difference in DRSP scale scores for the 3 functional impairment items, comparing the average over the last 5 days of daily scores from the 3rd cycle in the treatment phase to the average of daily scores from the 2 run in cycles | 3 cycles | |
| Descriptive statistics for total DRSP scale scores (sum of the first 21 items) of the last 5 days for each of the 2 run in cycles, each of the 3 cycles in the treatment phase, and the average of the 3 cycles in the treatment phase |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangzhou | Guangdong | 510405 | China | |||
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| ID | Term |
|---|---|
| D065446 | Premenstrual Dysphoric Disorder |
| ID | Term |
|---|---|
| D011293 | Premenstrual Syndrome |
| D008599 | Menstruation Disturbances |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Placebo |
| Drug |
Inert tablet |
|
| 3 cylces |
| Descriptive statistics for change in total DRSP scale scores (sum of the first 21 items) of the last 5 days from baseline to each cycle in the treatment phase and to the average of the 3 cycles in the treatment phase | 3 cycles |
| Assessment of CGI scores | 3 cycles |
| Adverse events | Whole study period |
| Laboratory tests | Whole study period |
| Guangzhou |
| Guangdong |
| 510630 |
| China |
| Wuhan | Hubei | 430060 | China |
| Changsha | Hunan | 410011 | China |
| Nanjing | Jiangsu | 210029 | China |
| Dalian | Liaoning | 116011 | China |
| Jinan | Shandong | 250012 | China |
| Xi’an | Shanxi | 710032 | China |
| Xi’an | Shanxi | 710061 | China |
| Chengdu | Sichuan | 610041 | China |
| Kunming | Yunnan | 650032 | China |
| Hangzhou | Zhejiang | 310003 | China |
| Beijing | 100050 | China |
| Beijing | 100191 | China |
| Beijing | 100853 | China |
| Tianjin | 300193 | China |
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |