A Study to Assess the Impact of Multiple Doses of AZD6234 on a Single Dose of Combined Oral Contraceptive in Female Participants

Launched by ASTRAZENECA · Jun 2, 2025

Keywords

ClinConnect Summary

This clinical trial is designed to study how a medication called AZD6234 affects the way a single dose of a combined oral contraceptive pill works in healthy women who are overweight or obese. The contraceptive pill being tested contains two hormones: ethinyl estradiol (EE) and levonorgestrel (LEVO). The researchers want to see if taking AZD6234 multiple times changes the effectiveness of this birth control pill.

To be eligible for this study, women must be between 18 and 40 years old, have a body mass index (BMI) of 25 or higher, and not be pregnant or breastfeeding. They should also agree to use a reliable method of contraception that does not include hormonal methods, as these could affect the study results. Participants will undergo screening tests to ensure they are healthy enough for the trial, and they will be monitored throughout the study. It’s important for potential participants to know that this study is not yet recruiting, so they will need to wait until it starts to apply.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • All participants must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit.
• • Women of childbearing potential must not be lactating and if heterosexually active, must agree to use an approved method of highly effective contraception.
• • o Hormonal contraceptives and estrogen-containing hormonal methods of birth control are not permitted due to potential effect and influence on the results using a combined oral contraceptive assessment.
• • Females of non-childbearing potential must be confirmed at the Screening Visit.
• • Have a Body Mass Index (BMI) ≥ 25 kg/m2 inclusive and weigh at least 60 kg.
• Exclusion Criteria:
• • History of any clinically important disease or disorder (gastroparesis, deep vein thrombosis, previous surgery of the upper gastrointestinal tract, cardiovascular disease, neuromuscular or neurogenic disease, severe vitamin D deficiency, type I or type II diabetes mellitus, glycated hemoglobin (HbA1c) ≥ 6.5%) at screening.
• • History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
• • Any clinically important illness, medical/surgical procedure, or trauma.
• • Any laboratory values with deviations or clinically important abnormalities in clinical chemistry, hematology, or urinalysis.
• • Any positive result on screening for serum Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (HBcAb) or Human immunodeficiency virus (HIV).
• • Abnormal vital signs.
• • Any clinically important abnormalities in rhythm, conduction, or morphology of the resting 12 lead electrocardiogram (ECG), at screening.
• • Current smokers or those who have smoked or used nicotine products.
• • Known or suspected history of alcohol or drug abuse or excessive intake of alcohol.
• • History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity.
• • Statin treatment within 4 weeks prior to the start of study treatment.
• • Current use of estrogen-containing products.