Novo Nordisk Investigational Site
Neuss, 41460, Germany
NCT Number: NCT01324505
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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Notify Me18 year and older
Female
Interventional
Phase 1
Neuss, 41460, Germany
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Placebo semaglutide will be administered once for securing eligibility of subjects (willingness and ability to self inject) at the screening visit.
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.
Time frame: in the 24 hour dosing interval
Time frame: in the 24 hour dosing interval
Time frame: in the 24 hour dosing interval
Time frame: in the 24 hour dosing interval
Time frame: within the weekly dosing interval
Time frame: from week 1 to end of trial at maximum 23 weeks
Novo Nordisk A/S
Industry
An Open-label, One-sequence Cross-over, Single Centre Trial Investigating the Influence of Semaglutide on Pharmacokinetics of Ethinylestradiol and Levonorgestrel in an Oral Contraceptive Combination Drug After Multiple Dose Administration of Semaglutide in Subjects With Type 2 Diabetes
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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