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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-003611-13 | EudraCT Number |
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This study will be investigated what mechanism of action Dienogest has. The growth of the follicles, the endometrium, the hormones in the blood and the mucus that is produced by the cervix that will be looked upon. Four different dosages of Dienogest (0.5 mg, 1 mg, 2 mg and 3 mg) will be investigated in healthy young women over two cycles, or up to a maximum of 72 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
| |
| Arm 2 | Experimental |
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| Arm 3 | Experimental |
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| Arm 4 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dienogest (81150037) | Drug | daily oral intake of 0.5 mg dienogest over two cycles or a max. of 72 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| No primary variables defined, all variables are considered exploratory since no confirmatory statistical analysis planned | No primary variables defined, all variables are considered exploratory since no confirmatory statistical analysis planned |
| Measure | Description | Time Frame |
|---|---|---|
| Course of gonadotropins (FSH, LH, P, E2) | During pre-treatment and treatment cycles (3 months) | |
| Endometrial thickness | During pre-treatment and treatment cycles (3 months) | |
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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 |
|---|---|---|---|---|---|---|
| Groningen | 9713 GZ | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22128200 | Result | Klipping C, Duijkers I, Remmers A, Faustmann T, Zurth C, Klein S, Schuett B. Ovulation-inhibiting effects of dienogest in a randomized, dose-controlled pharmacodynamic trial of healthy women. J Clin Pharmacol. 2012 Nov;52(11):1704-13. doi: 10.1177/0091270011423664. Epub 2011 Nov 29. |
| Label | URL |
|---|---|
| Click here and search for product information by EMA | View source |
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| ID | Term |
|---|---|
| C023635 | dienogest |
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| Dienogest (81150231) | Drug | daily oral intake of 1.0 mg dienogest over two cycles or a max. of 72 days |
|
| Dienogest (SH T00660A) | Drug | daily oral intake of 2.0 mg dienogest over two cycles or a max. of 72 days |
|
| Dienogest (81150746) | Drug | daily oral intake of 3.0 mg dienogest over two cycles or a max. of 72 days |
|
| Grading of ovarian activity |
| During pre-treatment and treatment cycles (3 months) |
| Effects on the cervix and the cervical mucus | During pre-treatment and treatment cycles (3 months) |
| mRNA expression profile of endometrial biopsies and in blood | once in pre-treatment and during treatment |
| Concentrations of DNG in serum | During pre-treatment and treatment cycles (3 months) |
| Safety and tolerability | During pre-treatment and treatment cycles (3 months) |