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| ID | Type | Description | Link |
|---|---|---|---|
| X311965 | Other Identifier | Company Internal |
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To evaluate efficacy and safety of a combined oral contraceptive of estradiol valerate and dienogest in the treatment of heavy menstrual bleeding
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
| |
| Arm 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EV/DNG (Qlaira, Natazia, BAY86-5027) | Drug | 2 days of 3 mg estradiol valerate (EV);5 days of 2 mg EV + 2 mg dienogest (DNG);17 days of 2 mg EV + 3 mg DNG;2 days of 1 mg EV;2 days of placebo. A blister card consists of 28 pills, taken orally once a day for 7 cycles of 28 days each. |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute change in Menstrual Blood Loss (MBL) at baseline and 90 days | 90 day baseline period and 90 days during treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects with successful treatment | Successful treatment is defined as no bleeding episode with MBL of 80 mL or more and a decrease to a value \ | 90 days during treatment phase |
| Percent change of MBL at baseline and 90 day period during 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 | 510120 | China | |||
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| placebo | Drug | Matching placebo to be taken orally daily for 7 cycles of 28 days each. |
|
| Baseline and 90 days during treatment phase |
| Absolute change of average MBL at baseline and up to cycle 7 (one cycle = 28 days) | Baseline and cycle 1, cycle 2, cycle 3, cycle 4, cycle 5, cycle 6, cycle 7 |
| Proportion of subjects with improvement in the investigator's global assessment scale on Day 84 | Investigator's global assessment scale: 0 = not assessed; 1 = very much improved; 2 = much improved; 3 = improved; 4 = no change; 5 = worse; 6 = much worse; 7 = very much worse; Improvement is defined as the assessment score = 1, 2, or 3. | Treatment day 84 |
| Proportion of subjects with improvement in the investigator's global assessment scale on Day 196 | Investigator's global assessment scale: 0 = not assessed; 1 = very much improved; 2 = much improved; 3 = improved; 4 = no change; 5 = worse; 6 = much worse; 7 = very much worse; Improvement is defined as the assessment score = 1, 2, or 3. | Treatment day 196 |
| Proportion of subjects with improvement in the subject's global assessment scale on Day 84 | Subject's global assessment scale: 0 = not assessed; 1 = very much improved; 2 = much improved; 3 = improved; 4 = no change; 5 = worse; 6 = much worse; 7 = very much worse; Improvement is defined as the assessment score = 1, 2, or 3. | Treatment day 84 |
| Proportion of subjects with improvement in the subject's global assessment scale on Day 196 | Subject's global assessment scale: 0 = not assessed; 1 = very much improved; 2 = much improved; 3 = improved; 4 = no change; 5 = worse; 6 = much worse; 7 = very much worse; Improvement is defined as the assessment score = 1, 2, or 3. | Treatment day 196 |
| Number of participants with adverse events as a measure of safety and tolerability | Up to 12 months |
| Nanning |
| Guangxi |
| 530021 |
| China |
| Shijiazhuang | Hebei | 050051 | China |
| Wuhan | Hubei | 430030 | China |
| Wuhan | Hubei | 430032 | China |
| Changsha | Hunan | 410013 | China |
| Hengyang | Hunan | 421001 | China |
| Dalian | Liaoning | 116011 | China |
| Shenyang | Liaoning | 110004 | China |
| Xi'an | Shaanxi | 710032 | China |
| Jinan | Shandong | 250012 | China |
| Chengdu | Sichuan | 610041 | China |
| Chengdu | Sichuan | 610072 | China |
| Beijing | 100026 | China |
| Beijing | 100034 | China |
| Beijing | 100044 | China |
| Beijing | 100730 | China |
| Changchun | China |
| Chongqing | 400010 | China |
| Qingdao | 266071 | China |
| Shanghai | 200030 | China |
| Shanghai | 2100129 | China |
| Tianjin | 300193 | China |
| Tianjin | 300211 | China |
| Manila | Philippines |
| Quezon City | Philippines |
| Irkutsk | 664003 | Russia |
| Ivanovo | 153045 | Russia |
| Krasnodar | 350012 | Russia |
| Moscow | 117049 | Russia |
| Moscow | 117415 | Russia |
| Saint Petersburg | 194354 | Russia |
| Saint Petersburg | 199034 | Russia |
| Singapore | 169608 | Singapore |
| Singapore | 229899 | Singapore |
| Taichung | 40705 | Taiwan |
| Tainan | Taiwan |
| Taipei | 100 | Taiwan |
| Taipei | 11217 | Taiwan |
| Bangkok | 10330 | Thailand |
| Bangkok | 10700 | Thailand |
| ID | Term |
|---|---|
| D008796 | Metrorrhagia |
| D008595 | Menorrhagia |
| ID | Term |
|---|---|
| D014592 | Uterine Hemorrhage |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008599 | Menstruation Disturbances |
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