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

NCT ID: NCT06188026

Last Updated: 2025-02-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-18
• Study Completion Date: 2024-12-30

Brief 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.

Conditions

Healthy Volunteers (Non-alcoholic Steatohepatitis)

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sequence 1

All participants will be exposed to both interventions in a defined sequence. OC 8 days, NNC0194-0499 4 weeks, OC/NNC0194-0499 combined 1 week.

Group Type: EXPERIMENTAL

NNC0194-0499

Intervention Type: DRUG

Once a week for 5 weeks as an injection in dose of 30 mg. The injection will be given under the skin

ethinylestradiol/levonorgestrel

Intervention Type: DRUG

Oral contraceptive is taken as tablet daily composed of 30 μg ethinylestradiol and 150 μg levonorgestrel.

Interventions

NNC0194-0499

Once a week for 5 weeks as an injection in dose of 30 mg. The injection will be given under the skin

Intervention Type: DRUG

ethinylestradiol/levonorgestrel

Oral contraceptive is taken as tablet daily composed of 30 μg ethinylestradiol and 150 μg levonorgestrel.

Intervention Type: DRUG

Eligibility Criteria

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, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.

Exclusion Criteria

• Any disorder which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
• Any contraindications for the use of the oral contraception used in the study according 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 any herbal medicine known to interfere with the metabolic CYP pathways, such as hypericum (St. John's Wort), ginseng, garlic, milk thistle, and echinaceae, within 14 days before screening. Exceptions are: use of routine vitamins (vitamins used within a normal dose reference interval), occasional use of paracetamol, non-steroidal anti-inflammatory drugs (NSAIDs), or topical medication not reaching systemic circulation.
• Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, gastrointestinal, or endocrinological conditions.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Transparency (dept. 2834)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

Medical University of Graz

Graz, , Austria

Countries

Austria

Other Identifiers

U1111-1279-3843

Identifier Type: OTHER

Identifier Source: secondary_id

2023-503595-24-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

NN9500-4619

Identifier Type: -

Identifier Source: org_study_id