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Clinical Trial Details

Trial ID: L5096
Source ID: NCT05153564
Associated Drug: Semaglutide 1.34 Mg/Ml
Title: A Research Study Looking Into the Effect of Semaglutide and NNC0480 0389 on Blood Levels of a Birth Control Pill in Woman After Menopause
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Semaglutide 1.34 mg/mL|DRUG: Semaglutide 3.0 mg/mL|DRUG: NNC0480-0389 10 mg/mL|DRUG: NNC0480-0389 30 mg/mL|DRUG: Microgynon®
Outcome Measures: Primary: Area under the ethinylestradiol plasma concentration time curve during a dosing interval (0 to 24 hours) at steady state (AUC0-24h,EE,SS), Measured in h\*pg/mL, From pre-dose to 24 hours after last dosing of oral contraceptive on day 8 and day 100|Area under the levonorgestrel plasma concentration time curve during a dosing interval (0 to 24 hours) at steady state (AUC0-24h,LN,SS), Measured in h\*pg/mL, From pre-dose to 24 hours after last dosing of oral contraceptive on day 8 and day 100 | Secondary: Maximum concentration of ethinylestradiol at steady state (Cmax,EE,SS), Measured in pg/mL, Within pre-dose to 24 hours after last dosing of oral contraceptive on day 8 and day 100|Maximum concentration of levonorgestrel at steady state (Cmax,LN,SS), Measured in pg/mL, Within pre-dose to 24 hours after last dosing of oral contraceptive on day 8 and day 100|Area under the paracetamol concentration-time curve for 0-60 minutes following a standardised meal (AUC0-60min,para), Measured in h\*μg/mL, From pre-dose to 60 minutes after dosing of paracetamol on day 1 and day 93|Area under the paracetamol concentration-time curve for 0-300 minutes following a standardised meal (AUC0-300min,para), Measured in h\*μg/mL, From pre-dose to 300 minutes after dosing of paracetamol on day 1 and day 93|Maximum observed paracetamol concentration following a standardised meal (Cmax,para), Measured in μg/mL, Within pre-dose to 300 minutes after dosing of paracetamol on day 1 and day 93
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: FEMALE
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 27
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2021-12-13
Completion Date: 2022-09-01
Results First Posted:
Last Update Posted: 2023-11-13
Locations: Novo Nordisk Investigational Site, Berlin, 10117, Germany
URL: https://clinicaltrials.gov/show/NCT05153564