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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-019902-17 | EudraCT Number |
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The objective of the study is to evaluate the effect of the dispenser's buzzer function on compliance with daily tablet intake of an ethinyl estradiol (EE) + drospirenone (DRSP) containing oral contraceptive (OC) in a flexible extended regimen when administered for approximately 12 months to healthy female volunteers who request contraception.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
| |
| Arm 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BAY86-5300 | Drug | 0.02 mg EE as ß-CDC / 3 mg DRSP in a tablet form (1 tablet/day) for up to 120 days, followed by a 4-day tablet-free interval, administered with a dispenser supported by a reminder function |
| Measure | Description | Time Frame |
|---|---|---|
| Mean daily delay of tablet release, i.e. the time of tablet-release which will be compared to the reference tablet release time | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of delayed and missed pills | 12 months | |
| Bleeding pattern and cycle control parameters | 12 months | |
| Length of the tablet break and the length of the bleeding episode preceding the tablet break |
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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 |
|---|---|---|---|---|---|---|
| Paris | Paris | 75018 | France | |||
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| Label | URL |
|---|---|
| Click here to find information about studies related to Bayer Healthcare products conducted in Europe | View source |
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| BAY86-5300 | Drug | 0.02 mg EE as ß-CDC / 3 mg DRSP in a tablet form (1 tablet/day) for up to 120 days, followed by a 4-day tablet-free interval, administered with a dispenser without reminder support |
|
| 12 months |
| Biarritz |
| 64200 |
| France |
| Marly-le-Roi | 78160 | France |
| Nancy | 54000 | France |
| Olivet | 45160 | France |
| Paris | 75 009 | France |
| Paris | 75 017 | France |
| Paris | 75007 | France |
| Strasbourg | 67 000 | France |
| Toulouse | 31000 | France |
| Heidelberg | Baden-Wurttemberg | 69115 | Germany |
| Hamburg | Free and Hanseatic City of Hamburg | 20357 | Germany |
| Frankfurt am Main | Hesse | 60590 | Germany |
| Wuppertal | North Rhine-Westphalia | 42103 | Germany |
| Blankenburg | Saxony-Anhalt | 38889 | Germany |
| Burg | Saxony-Anhalt | 39288 | Germany |
| Magdeburg | Saxony-Anhalt | 39130 | Germany |
| Gera | Thuringia | 07545 | Germany |
| Kahla | Thuringia | 07768 | Germany |
| Bologna | 40138 | Italy |
| Brescia | 25123 | Italy |
| Cagliari | 09124 | Italy |
| Catania | 95123 | Italy |
| Milan | 20154 | Italy |
| Modena | 41124 | Italy |
| Naples | 80138 | Italy |
| Palermo | 90127 | Italy |
| Pavia | 27100 | Italy |
| Pisa | 56126 | Italy |
| Roma | 00189 | Italy |
| Siena | 53100 | Italy |
| Elda | Alicante | 03600 | Spain |
| Barcelona | Barcelona | 08019 | Spain |
| Córdoba | Córdoba | 14004 | Spain |
| Boadilla del Monte | Madrid | 28660 | Spain |
| Málaga | Málaga | 29013 | Spain |
| Chesterfield | Derbyshire | S40 4TF | United Kingdom |
| Nottingham | Nottinghamshire | NG2 4PJ | United Kingdom |
| Bath | Somerset | BA1 2SR | United Kingdom |
| East Horsley | Surrey | KT24 6QT | United Kingdom |
| Bradford-on-Avon | Wiltshire | BA15 1DQ | United Kingdom |
| Corsham | Wiltshire | SN3 9DL | United Kingdom |
| Cardiff | CF5 4AD | United Kingdom |