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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1119-2214 | Other Identifier | WHO | |
| 2010-022435-11 | EudraCT Number |
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This clinical trial is conducted in Europe. The purpose of the trial is to investigate the influence on the pharmacokinetics (the rate at which the trial drug is eliminated from the body) of an oral contraceptive combination drug after multiple administration of semaglutide in female subjects with type 2 diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| One-sequence cross-over arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| semaglutide | Drug | Semaglutide will be administered once weekly by s.c. (under the skin) injections in the abdomen. A total of 13 doses of semaglutide will be administered according to a predefined dosing scheme |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the ethinylestradiol concentration-time curve | in the 24 hour dosing interval | |
| Area under the levonorgestrel concentration-time curve | in the 24 hour dosing interval |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum oral contraceptive concentration | in the 24 hour dosing interval | |
| Area under the semaglutide concentration-time curve | in the 24 hour dosing interval | |
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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 | Neuss | 41460 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Kapitza C, Nosek L, Jensen L, Hartvig H, Jensen CB, Flint A. Semaglutide, a once-weekly human GLP-1 analogue, does not reduce the bioavailability of oral contraceptives in patients with type 2 diabetes. Diabetes 2014; 63 (suppl 1): A595-A631 (2383-PO) |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| 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 |
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| placebo | Drug | Placebo semaglutide will be administered once for securing eligibility of subjects (willingness and ability to self inject) at the screening visit. |
|
| Microgyn® | Drug | Microgyn® will be given as once daily oral dosing in two periods, each of 8 days' duration. One tablet contains levonorgestrel 0.15 mg and ethinylestradiol 0.03 mg. |
|
| Maximum semaglutide concentration |
| within the weekly dosing interval |
| Percentage of subjects experiencing adverse events | from week 1 to end of trial at maximum 23 weeks |