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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-004232-35 | EudraCT Number | ||
| U1111-1174-7914 | Other Identifier | WHO |
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This trial is conducted in Europe. The aim of the trial is to investigate the influence of oral semaglutide on pharmacokinetics (the exposure of the trial drug in the body) of ethinylestradiol and levonorgestrel in an oral contraceptive combination drug in healthy postmenopausal females.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral contraceptive/SNAC/Oral Trial drug | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| semaglutide | Drug | Oral administration once daily alone or together with oral contraceptive. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the ethinylestradiol plasma concentration-time curve during a dosing interval (0-24 hours) at steady state | On day 8 (OC alone), day 24 (OC with SNAC) and day 82 (OC with oral semaglutide at steady state) | |
| Area under the levonorgestrel plasma concentration-time curve during a dosing interval (0-24 hours) at steady state | On day 8 (OC alone), day 24 (OC with SNAC) and day 82 (OC with oral semaglutide at steady state) |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed ethinylestradiol plasma concentration during a dosing interval (0-24 hours) at steady state | On day 8 (OC alone), day 24 (OC with SNAC) and day 82 (OC with oral semaglutide at steady state) | |
| Maximum observed levonorgestrel plasma concentration during a dosing interval 0-24 hours) at steady state |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Berlin | 14050 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33782832 | Derived | Jordy AB, Albayaty M, Breitschaft A, Anderson TW, Christiansen E, Houshmand-Oregaard A, Manigandan E, Baekdal TA. Effect of Oral Semaglutide on the Pharmacokinetics of Levonorgestrel and Ethinylestradiol in Healthy Postmenopausal Women and Furosemide and Rosuvastatin in Healthy Subjects. Clin Pharmacokinet. 2021 Sep;60(9):1171-1185. doi: 10.1007/s40262-020-00976-x. |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| SNAC | Drug | Oral administration once daily together with oral contraceptive. |
|
| Microgynon® | Drug | Oral administration once daily alone or together with oral semaglutide or SNAC. |
|
| On day 8 (OC alone), day 24 (OC with SNAC) and day 82 (OC with oral semaglutide at steady state) |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C000591245 | semaglutide |
| C072593 | ethinyl estradiol, levonorgestrel drug combination |
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