A Research Study Looking at How the Compound NNC0194-0499 Works With Birth Control Pills in Women Not Able to Bear Children.

Last updated: February 16, 2025
Sponsor: Novo Nordisk A/S
Overall Status: Completed

Phase

1

Condition

Liver Disease

Treatment

ethinylestradiol/levonorgestrel

NNC0194-0499

Clinical Study ID

NCT06188026
NN9500-4619
U1111-1279-3843
2023-503595-24-00
  • Ages 18-65
  • Female
  • Accepts Healthy Volunteers

Study Summary

The study will investigate the influence of NNC0194-0499 on the blood levels of the two components of a birth control pill, Microgynon®. Participants will get the birth control pill in form of tablets in two periods of 8 days each.

Participants will get NNC0194-0499 as injection under the skin of their thigh. The injections will be given once weekly for 5 weeks.

The study will last for about 11 to 15 weeks, depending on the length of the screening period.

Participants will have to stay overnight at the study centre (2 nights and 4 nights, respectively) Only healthy women who are not able to bear children can take part in this study.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Female of non-childbearing potential.

  • Age 18-65 years (both inclusive) at the time of signing the informed consent.

  • Body mass index (BMI) between 18.5 and 29.9 kg/m^2 (both inclusive) at screening.

  • Considered to be generally healthy based on the medical history, physicalexamination, and the results of vital signs, electrocardiogram and clinicallaboratory tests performed during the screening visit, as judged by theinvestigator.

Exclusion

Exclusion Criteria:

  • Any disorder which in the investigator's opinion might jeopardise participant'ssafety or compliance with the protocol.

  • Any contraindications for the use of the oral contraception used in the studyaccording to the Prescription Drug Information.

  • Sitting blood pressure at screening outside the range of 90-139 mmHg for systolic or 50-89 mmHg for diastolic.

  • Pulse outside the range of 50-89 beats/minute at screening

  • Use of prescription medicinal products or non-prescription drugs including anyherbal medicine known to interfere with the metabolic CYP pathways, such ashypericum (St. John's Wort), ginseng, garlic, milk thistle, and echinaceae, within 14 days before screening. Exceptions are: use of routine vitamins (vitamins usedwithin a normal dose reference interval), occasional use of paracetamol,non-steroidal anti-inflammatory drugs (NSAIDs), or topical medication not reachingsystemic circulation.

  • Presence or history of any clinically relevant respiratory, metabolic, renal,hepatic, gastrointestinal, or endocrinological conditions.

Study Design

Total Participants: 34
Treatment Group(s): 2
Primary Treatment: ethinylestradiol/levonorgestrel
Phase: 1
Study Start date:
December 18, 2023
Estimated Completion Date:
December 30, 2024

Connect with a study center

  • Medical University of Graz

    Graz, 8010
    Austria

    Site Not Available

  • Novo Nordisk Investigational Site

    Graz, 8010
    Austria

    Active - Recruiting

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