| Trial ID: | L4365 |
| Source ID: | NCT02845219
|
| Associated Drug: |
Semaglutide
|
| Title: |
A Trial Investigating the Influence of Oral Semaglutide on Pharmacokinetics of Ethinylestradiol and Levonorgestrel in an Oral Contraceptive Combination Drug in Healthy Postmenopausal Females
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes|Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: semaglutide|DRUG: SNAC|DRUG: Microgynon®
|
| Outcome Measures: |
Primary: 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) | Secondary: 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, On day 8 (OC alone), day 24 (OC with SNAC) and day 82 (OC with oral semaglutide at steady state)
|
| Sponsor/Collaborators: |
Sponsor: Novo Nordisk A/S
|
| Gender: |
FEMALE
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
25
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2016-07
|
| Completion Date: |
2016-12
|
| Results First Posted: |
|
| Last Update Posted: |
2017-06-07
|
| Locations: |
Novo Nordisk Investigational Site, Berlin, 14050, Germany
|
| URL: |
https://clinicaltrials.gov/show/NCT02845219
|
