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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-005280-89 | EudraCT Number |
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The clinical phase I study aims at investigating the conversion of the contraceptive compound norethisterone within the body towards the contraceptive compound ethinylestradiol. Therefore concentrations of ethinylestradiol will be measured from blood samples after administration of a single intramuscular dose of norethisterone. In a comparison arm concentrations of ethinylestradiol will be measured from blood samples after administration of a pill containing ethinylestradiol itself.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | Healthy premenopausal subjects will receive multiple oral doses of Microgynon for 21days |
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| Arm 2 | Experimental | Healthy premenopausal subjects will receive a single intramuscular dose of Noristerat |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Microgynon | Drug | Subjects will receive 21 daily oral doses of Microgynon tablets containing 0.15 mg levonorgestrel und 0.03 mg ethinylestradiol. |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed drug concentration of ethinylestradiol at steady state after multiple administrations of Microgynon (Cmax)ss | At different time points on day 21 | |
| Area under the concentration-time curve of ethinylestradiol at steady state after multiple administrations of Microgynon {AUC(0-24)}ss | At different time points on day 21 | |
| Maximum observed drug concentration of ethinylestradiol after single administration of Noristerat (Cmax) | At different time points upto 8 weeks | |
| Area under the concentration-time curve of ethinylestradiol after single administration of Noristerat (AUC) | At different time points up to 8 weeks | |
| Maximum observed drug concentration of Norethisterone after single administration of Noristerat (Cmax) | At different time points up to 8 weeks | |
| Area under the concentration-time curve of Norethisterone after single administration of Noristerat (AUC) | At different time points up to 8 weeks |
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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 | 13353 | Germany |
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| Noristerat(BAY86-6308) | Drug | Subjects will receive one intramuscular dose of Noristerat (oily solution for intramuscular injection) containing 200 mg norethisterone enantate. |
|
| ID | Term |
|---|---|
| C072593 | ethinyl estradiol, levonorgestrel drug combination |
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