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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-004544-73 | EudraCT Number | ||
| 311623 | Other Identifier | Company internal |
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Investigation of a new pill containing an estrogen and a progestin in order to monitor the inhibition of the ovulation in young healthy females over 3 treatment cycles
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
| |
| Arm 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BAY86-4891 (Estradiol / Drospirenone) | Drug | Monophasic regimen containing estrogen and progestin 1 pre-treatment cycle, 3 treatment cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary efficacy variable will be the proportion of volunteers with ovulation in at least one of the treatment cycles 2 and 3, based on the binary variable ovulation (i.e. Hoogland score 6) with the levels yes and no | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of ovarian activity in treatment cycles 2 and 3 | 12 months | |
| Course of gonadotropins (FSH, LH) | 12 months | |
| Endometrial growth |
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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 |
|---|---|---|---|---|---|---|
| Berlin | State of Berlin | 10115 | Germany | |||
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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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| BAY86-4891 (Estradiol / Drospirenone) | Drug | Triphasic regimen containing estrogen and progestin 1 pre-treatment cycle, 3 treatment cycles |
|
| 12 months |
| Pharmacokinetics of estrogen and progestin in treatment cycle 3 | 12 months |
| Berlin |
| State of Berlin |
| 13353 |
| Germany |
| ID | Term |
|---|---|
| D004958 | Estradiol |
| C035144 | drospirenone |
| ID | Term |
|---|---|
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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