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| ID | Type | Description | Link |
|---|---|---|---|
| 308021 |
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The purpose of this study is to determine whether the study drug is effective in prevention of pregnancy in healthy women in reproductive age
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YAZ (DRSP 3 mg/EE 0.02 mg, BAY86-5300) | Drug | Oral administration of YAZ (0.02mg ethinyl estradiol-ß-cyclodextrin clathrate and 3mg drospirenone, 24 day hormone tablets followed by 4 days of placebo tablets for 13 cycles |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of unintended pregnancies (Pearl index) | 13 cycles of 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Physical and gynecological examination | screening, cycle 6 and final examination | |
| Vital signs | each visit | |
| Body weight |
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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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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21721590 | Result | Anttila L, Neunteufel W, Petraglia F, Marr J, Kunz M. Cycle control and bleeding pattern of a 24/4 regimen of drospirenone 3 mg/ethinylestradiol 20 mug compared with a 21/7 regimen of desogestrel 150 mug/ethinylestradiol 20 mug: a pooled analysis. Clin Drug Investig. 2011;31(8):519-525. doi: 10.2165/11590260-000000000-00000. | |
| 21277674 |
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| ID | Term |
|---|---|
| C534342 | drospirenone and ethinyl estradiol combination |
| C035144 | drospirenone |
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| each visit |
| Cervical smear | each visit |
| Anttila L, Bachmann G, Hernadi L, Kunz M, Marr J, Klipping C. Contraceptive efficacy of a combined oral contraceptive containing ethinyloestradiol 20 mug/drospirenone 3mg administered in a 24/4 regimen: a pooled analysis of four open-label studies. Eur J Obstet Gynecol Reprod Biol. 2011 Apr;155(2):180-2. doi: 10.1016/j.ejogrb.2010.12.037. Epub 2011 Feb 1. |