Investigation of the Effect of Subcutaneously Co-administered Semaglutide and NNC0480-0389 on Pharmacokinetics of an Oral Combination Contraceptive (Ethinylestradiol and Levonorgestrel) in Healthy Postmenopausal Females

Registration

Registration

NCT05153564

Study type

INTERVENTIONAL

Phase

PHASE1

Masking

NONE

Status

COMPLETED

Enrollment

27

Start

2021-12-13

Primary completion

2022-08-13

Lead sponsor

Novo Nordisk A/S

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®

Results posted

FALSE

Individual participant data sharing

YES

Secondary identifiers

EUDRACT_NUMBER:2021-003060-27; OTHER:U1111-1266-3910

Registered primary outcomes

• Area under the ethinylestradiol plasma concentration time curve during a dosing interval (0 to 24 hours) at steady state (AUC0-24h,EE,SS) [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) [From pre-dose to 24 hours after last dosing of oral contraceptive on day 8 and day 100]