This study is a Phase III, multicenter, open-label, single-arm clinical trial designed to evaluate the contraceptive efficacy and safety of a new formulation containing N0999 in women of childbearing potential. Approximately 1,600 post-menarche women aged 14 to 45 years who are candidates for systemic hormonal contraception are expected to be enrolled.
All participants will receive the investigational product, consisting of N0999 administered in a 24+4 regimen. Each treatment cycle consists of 24 active tablets followed by 4 inactive tablets. Participants will receive treatment for 13 consecutive 28-day cycles, corresponding to approximately 52 weeks of treatment. Total study participation, including screening and follow-up, is expected to be approximately 58 weeks.
The primary objective of the study is to evaluate contraceptive efficacy over 13 treatment cycles using the Pearl Index in participants aged 35 years or younger. Secondary objectives include assessing the Pearl Index in the overall study population and in participants older than 35 years, evaluating the method-failure Pearl Index based on correct and consistent use, and estimating cumulative pregnancy rates using Life Table Analysis.
Additional objectives include evaluating cycle control, including withdrawal bleeding, intermenstrual spotting, amenorrhea, and bleeding duration, as well as participant satisfaction with study treatment. Exploratory assessments of clinical and laboratory signs of hyperandrogenism will also be performed.
The safety and tolerability of the investigational product will be evaluated throughout the study by monitoring adverse events, serious adverse events, adverse events of special interest, safety-related discontinuations, clinically relevant findings, and laboratory assessments. An Independent Data and Safety Monitoring Committee will oversee participant safety during the trial.
Participants who wish to become pregnant after completing treatment may participate in an additional exploratory follow-up period of up to 12 months to characterize the return of spontaneous menstruation
Ability to voluntarily participate in the study and provide written informed consent (and assent, where applicable) before the performance of any study-specific procedures.
Biological female aged 14 to 45 years (inclusive) at the time of informed consent/assent.
Post-menarche for at least 1 year.
Regular menstrual cycles lasting 21 to 35 days documented during the 3 months prior to screening (for women not using hormonal contraception at screening).
Confirmed or suspected pregnancy, or plans to become pregnant within the next 12 weeks.
Childbirth, abortion, or breastfeeding within the previous 3 months.
Personal history of cardiovascular disease, including myocardial infarction, stroke, coronary artery disease, peripheral arterial disease, venous thromboembolic disease (deep vein thrombosis or pulmonary embolism), arterial thromboembolic disease, or any condition that increases the risk of these disorders.
Known history of cardiomyopathy, heart failure, or clinically significant cardiac arrhythmia requiring continuous antiarrhythmic therapy.