This is a registry record, not a result. A trial being listed, recruiting or completed says nothing by itself about whether the compound works or is safe.
| Registry number | NCT05896384 |
|---|---|
| Status | Completed |
| Phase | Phase 1 |
| Sponsor | Boehringer Ingelheim |
| Enrollment | 32 participants |
| Design | Interventional, Na, Single Group, Masking: None |
| Conditions | Healthy |
| Interventions | BI 456906; Microgynon® |
| Start | Dec 21, 2023 |
| Primary completion | Feb 14, 2025 |
| Study completion | Mar 26, 2025 |
| Results posted | Not yet |
| Registry last updated | Apr 16, 2025 |
Compounds on this site that cite this trial
What the registry says the trial is about
This study is open to women with overweight or obesity who are otherwise healthy. Women with a body mass index (BMI) from 27 to 40 kg/m2 can participate. The purpose of this study is to find out whether taking multiple doses of BI 456906 influences the amount of ethinylestradiol and levonorgestrel in the blood. Ethinylestradiol and levonorgestrel are ingredients of the contraceptive Microgynon®.
The study has 2 treatment periods. In Period 1, participants get 1 tablet of Microgynon®. In Period 2, participants get weekly injections of BI 456906 for 7 months. The doses of BI 456906 increase each month. At 8 specific timepoints during Period 2, participants also get 1 tablet of Microgynon®.
Participants visit the study site up to 40 times. At 8 visits, participants take Microgynon® and stay overnight at the site. During the visits, the doctors collect information about participants' health and take blood samples from the participants. They compare the amount of ethinylestradiol and levonorgestrel in the blood in Period 2 with the amounts in Period 1. Doctors also regularly check participants' health and take note of any unwanted effects.
Primary outcomes
These are what the trial was designed to measure first. They are registered in advance, which is what makes a later result checkable.
| Outcome measure | Time frame |
|---|---|
| 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 |
Source: ClinicalTrials.gov (U.S. National Library of Medicine). Last checked against the registry on Oct 3, 2026. See the trial changes feed for what has changed recently.
