A Study in Women With Overweight or Obesity to Test Whether Different Doses of BI 456906 Influence the Amount of a Contraceptive in the Blood

Sponsor
Boehringer Ingelheim
Study ID
NCT05896384
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

  • BI 456906 — DRUG
    BI 456906
  • Microgynon® — DRUG
    Ethinylestradiol (EE) and Levonorgestrel (LNG)

Study Details

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.

Key Dates

Start date
Dec 21, 2023
Status verified
Apr 2025
Primary completion
Feb 14, 2025
Completion
Mar 26, 2025

Study Design

Enrollment
32 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Microgynon® (Reference treatment (R)) followed by BI 456906 and Microgynon® (Test treatment (T))

Primary Outcome Measure

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

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