Study S001523

A Non-randomised, Open-label Phase I Trial to Evaluate the Effect of BI 456906 at Different Dose Levels of Multiple Subcutaneous Doses in a Titration Scheme on the Single Dose Pharmacokinetics of a Combination of Ethinylestradiol and Levonorgestrel in Otherwise Healthy Women With Overweight/Obesity

ClinicalTrials.gov record

Registration

Registration: NCT05896384
Study type: INTERVENTIONAL
Phase: PHASE1
Masking: NONE
Status: COMPLETED
Enrollment: 32
Start: 2023-12-21
Primary completion: 2025-02-14
Lead sponsor: Boehringer Ingelheim
Conditions: Healthy
Interventions: DRUG:BI 456906; DRUG:Microgynon®
Results posted: FALSE
Individual participant data sharing: NO
Secondary identifiers: REGISTRY:2022-503146-53-00

Registered primary outcomes

Area under the concentration-time curve of ethinylestradiol in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) [up to Week 29]
Maximum measured concentration of ethinylestradiol in plasma (Cmax) [up to Week 29]
Area under the concentration-time curve of levonorgestrel in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) [up to Week 29]
Maximum measured concentration of levonorgestrel in plasma (Cmax) [up to Week 29]

Linked records (0)

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.

No records link to this registration yet.