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| ID | Type | Description | Link |
|---|---|---|---|
| 307987 | Other Identifier | Other company ID |
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The purpose of this study is to investigate the contraceptive efficacy, bleeding pattern, and safety of SH D00342A. Subjects participating in the study will be treated with an oral contraceptive pill containing 0.03 mg ethinylestradiol and 0.125 mg levonorgestrel.
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 |
|---|---|---|---|---|
| Minisiston (SH D00342A) | Drug | Daily oral administration in 21 days per cycle, followed by a 7-day pill-free interval |
|
| Measure | Description | Time Frame |
|---|---|---|
| Unadjusted Pearl Index | After 13 cycles of intake |
| Measure | Description | Time Frame |
|---|---|---|
| Adjusted Pearl Index | After 13 cycles of intake | |
| Cumulative pregnancy rate | After 13 cycles of intake | |
| Bleeding pattern |
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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 |
|---|---|---|---|---|---|---|
| Hanover | Lower Saxony | 30159 | Germany | |||
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| After 13 cycles of intake |
| Cycle control | After 13 cycles of intake |
| Dresden |
| Saxony |
| 01067 |
| Germany |
| Dresden | Saxony | 01099 | Germany |
| Dresden | Saxony | 01108 | Germany |
| Dresden | Saxony | 01324 | Germany |
| Großpösna | Saxony | 04463 | Germany |
| Leipzig | Saxony | 04207 | Germany |
| Leipzig | Saxony | 04277 | Germany |
| Leipzig | Saxony | 04279 | Germany |
| Aschersleben | Saxony-Anhalt | 06449 | Germany |
| Burg | Saxony-Anhalt | 39288 | Germany |
| Egeln | Saxony-Anhalt | 39435 | Germany |
| Halberstadt | Saxony-Anhalt | 38820 | Germany |
| Halberstadt | Saxony-Anhalt | 38821 | Germany |
| Jessen | Saxony-Anhalt | 06917 | Germany |
| Magdeburg | Saxony-Anhalt | 39112 | Germany |
| Magdeburg | Saxony-Anhalt | 39120 | Germany |
| Magdeburg | Saxony-Anhalt | 39126 | Germany |
| Berlin | State of Berlin | 10179 | Germany |
| Berlin | State of Berlin | 10247 | Germany |
| Berlin | State of Berlin | 10409 | Germany |
| Berlin | State of Berlin | 12435 | Germany |
| Berlin | State of Berlin | 13507 | Germany |
| Suhl | Thuringia | 98527 | Germany |
| Weida | Thuringia | 07579 | Germany |
| ID | Term |
|---|---|
| D019304 | Ethinyl Estradiol-Norgestrel Combination |
| ID | Term |
|---|---|
| D004997 | Ethinyl Estradiol |
| D009651 | Norpregnatrienes |
| D009650 | Norpregnanes |
| D009654 | Norsteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D009644 | Norgestrel |
| D009652 | Norpregnenes |
| D042782 | Estrogenic Steroids, Alkylated |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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