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| ID | Type | Description | Link |
|---|---|---|---|
| 307300 |
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The aim of the study is to investigate the ovulation inhibition of two 4-phasic oral contraceptive regimens.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
| |
| Arm 2 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EV/DNG (Qlaira, BAY86-5027, SH T00658K) | Drug | Estradiol valerate (EV) and dienogest (DNG) in a sequential 4-phasic regimen, EV 3, 2, and 1 mg and DNG 2 and 3 mg |
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects with a Hoogland score of 5-6 (luteinized unruptured follicle [LUF] or ovulation) | Treatment cycles 2 and 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects with a Hoogland score of 5-6 (LUF or ovulation) | Treatment cycles 2 or 3 | |
| Measurements of endometrial thickness | Treatment cycles 2 and 3 | |
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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 |
|---|---|---|---|---|---|---|
| Dinox GmbH Berlin | Berlin | State of Berlin | 10115 | Germany | ||
| Dinox B.V. |
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| EV/DNG (SH T00658L) | Drug | Estradiol valerate (EV) and dienogest (DNG) in a sequential 4-phasic regimen, EV 3, 2, and 1 mg and DNG 3 and 4 mg |
|
| Visibility of cervical mucus |
| Treatment cycles 2 and 3 |
| Ovarian activity (Hoogland score) | Posttreatment cycle (only subjects from center 2)Treatment cycles 2 and 3 |
| Measurements of follicle size | Treatment cycles 2 and 3 |
| Measurements of hormone levels (follicle-stimulating hormone [FSH], luteinizing hormone [LH], progesterone and estradiol) | Treatment cycles 2 and 3 |
| Compliance | Throughout whole study |
| Medical, surgical and medication history, concomitant medication, general physical and gynecological examination, cervical smear, pregnancy test, adverse events, safety laboratory determinations, cycle control, vital signs | Various timepoint throughout the study |
| Groningen |
| 9713 GZ |
| Netherlands |