Study S001553

A Trial Investigating the Influence of Oral Semaglutide on Pharmacokinetics of Ethinylestradiol and Levonorgestrel in an Oral Contraceptive Combination Drug in Healthy Postmenopausal Females

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: NCT02845219
Study type: INTERVENTIONAL
Phase: PHASE1
Masking: NONE
Status: COMPLETED
Enrollment: 25
Start: 2016-07
Primary completion: 2016-12
Lead sponsor: Novo Nordisk A/S
Conditions: Diabetes; Diabetes Mellitus, Type 2
Interventions: DRUG:semaglutide; DRUG:SNAC; DRUG:Microgynon®
Results posted: FALSE
Secondary identifiers: EUDRACT_NUMBER:2015-004232-35; OTHER:U1111-1174-7914; NIH:2015

Registered primary outcomes

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)]

Linked records (1)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.

Record	Title	Year	Design	Identifiers	Link basis
R0008631	Effect of Oral Semaglutide on the Pharmacokinetics of Levonorgestrel and Ethinylestradiol in Healthy Postmenopausal Women and Furosemide and Rosuvastatin in Healthy Subjects. Jordy AB, Clinical pharmacokinetics	2021	Other trial	PMID 33782832 DOI	cites ClinicalTrials.gov:NCT02845219; registry reference DERIVED:33782832