Study S002777

Investigation of the Effect of NNC0174-0833 on Pharmacokinetics of an Oral Combination Contraceptive (Ethinylestradiol and Levonorgestrel) in Females of Non-childbearing Potential

Name: LivingGLP1 adjudicated trial data and network meta-analysis results
Creator: Ahmad Sofi-Mahmudi
License: https://creativecommons.org/licenses/by/4.0/

ClinicalTrials.gov record

Registration

Registration: NCT04074174
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE1
Masking: NONE
Status: COMPLETED
Enrollment: 31
Start: 2019-09-12
Primary completion: 2020-03-06
Lead sponsor: Novo Nordisk A/S
Conditions: Overweight; Obesity
Interventions: DRUG:NNC0174-0833; DRUG:Oral contraceptive (OC) tablets; DRUG:Acetaminophen
Results posted: FALSE
Individual participant data sharing: YES
Secondary identifiers: OTHER:U1111-1228-4219

Registered primary outcomes

AUC0-24h,EE,SS area under the ethinylestradiol concentration-time curve during a dosing interval (0-24 hours) at steady state [Day 8 (predose to 24 hours post-dose) and Day 79 (predose to 24 hours post-dose)]
AUC0-24h,LN,SS area under the levonorgestrel concentration-time curve during a dosing interval (0-24 hours) at steady state [Day 8 (predose to 24 hours post-dose) and Day 79 (predose to 24 hours post-dose)]

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