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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-003924-29 | EudraCT Number |
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The objective of this study is to investigate the safety and efficacy of (0.02 mg EE as betadex clathrate [β-CDC]) / 3 mg drospirenone (DRSP) for dysmenorrhea. In order to appropriately evaluate the efficacy of EE(β-CDC)/DRSP the study was set up as a placebo-controlled comparative study
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BAY86-5300 | Experimental | Patients suffering from dysmenorrhea, treated with Yaz |
|
| Placebo | Placebo Comparator | Patients suffering from dysmenorrhea,treated with placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EE20/DRSP(YAZ,BAY86-5300) | Drug | 0.02 mg EE (β-CDC)/3 mg DRSP for 24 days and placebo tablets for 4 days per 28-day intake cycle |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in visual analogue scale (VAS) score for pain due to dysmenorrhea from baseline to Visit 6 | The patient marks the individual pain impression on a visual analogue scale in the range 0 (no pain) to 100mm (worst pain ever experienced) | Baseline to week 17 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events as measure of safety and tolerability | Up to 16 weeks | |
| Number of days with dysmenorrhea | The occurrence of dysmenorrhea will be recorded in the patient diary |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
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| ID | Term |
|---|---|
| D004412 | Dysmenorrhea |
| ID | Term |
|---|---|
| D008599 | Menstruation Disturbances |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017699 | Pelvic Pain |
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| Placebo | Drug | Matching placebo tablets for 28 days per 28-day intake cycle |
|
| Up to 16 weeks |
| Change in dysmenorrhea score | It is the sum of two four-stage sub-scales which assess the extent to which dysmenorrhea interferes with daily life & the extent to which pain medication is used. | Baseline to week 16 |
| Changes from baseline to each menstrual period of total number of taken supportive analgesic medication | Standard Analgesic tablets are provided to participants | Baseline to week 16 |
| Changes from baseline to each menstrual period of days without supportive analgesic medication. | Baseline to week 16 |
| Clinical Global Impression(CGI) | The CGI is the measure of global improvement index from the opinion of the investigator and subject to document changes in the health status during treatment | At week 16 |
| Self administered SF-36 questionnaire | The 36-items Short Form Health Survey (SF-36) (version 2.0) is a set of generic, coherent,and easily administered quality-of-life measures. | At baseline and week 17 |
| Changes from baseline to each menstrual period of severity of lumbago | The patient classifies the severity on a mild, moderate, severe scale | Up to 16 weeks |
| Changes from baseline to each menstrual period of severity of headache | The patient classifies the severity on a mild, moderate, severe scale | Up to 16 weeks |
| Changes from baseline to each menstrual period of severity of nausea/vomiting | The patient classifies the severity on a mild, moderate, severe scale | Up to 16 weeks |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |