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| ID | Type | Description | Link |
|---|---|---|---|
| 2006-003904-21 | EudraCT Number |
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This trial is conducted in Europe. The aim of this trial is to investigate if liraglutide changes AUC (area under the curve) of ethinylestradiol and levonorgestrel administered as a combination contraceptive drug (Neovletta®).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment period 1 | Experimental |
| |
| Treatment period 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| liraglutide | Drug | Administered with daily subcutaneous injections for approximately 3 weeks in each treatment period in random order |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUC of ethinylestradiol | ||
| AUC of levonorgestrel |
| Measure | Description | Time Frame |
|---|---|---|
| AUC (0-t) | ||
| Cmax, maximum concentration | ||
| tmax, time to reach Cmax |
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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 | Uppsala | 75323 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25504028 | Result | Jensen TM, Saha K, Steinberg WM. Is there a link between liraglutide and pancreatitis? A post hoc review of pooled and patient-level data from completed liraglutide type 2 diabetes clinical trials. Diabetes Care. 2015 Jun;38(6):1058-66. doi: 10.2337/dc13-1210. Epub 2014 Dec 12. |
| 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 |
|---|---|
| D000069450 | Liraglutide |
| D016912 | Levonorgestrel |
| D004997 | Ethinyl Estradiol |
| ID | Term |
|---|---|
| D052216 | Glucagon-Like Peptide 1 |
| D004763 | Glucagon-Like Peptides |
| D052336 | Proglucagon |
| D005768 | Gastrointestinal Hormones |
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| placebo | Drug | Administered with daily subcutaneous injections for approximately 3 weeks in each treatment period in random order |
|
| levonorgestrel / ethinylestradiol | Drug | One single oral tablet after the liraglutide or placebo dose administration at the end of each treatment period |
|
| t½, terminal half-life |
| Adverse events |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009644 | Norgestrel |
| D009652 | Norpregnenes |
| D009650 | Norpregnanes |
| D009654 | Norsteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D009651 | Norpregnatrienes |
| D042782 | Estrogenic Steroids, Alkylated |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |