Evaluation of the Pharmacokinetic Interaction Between Obefazimod and Ethinyl Estradiol/Drospirenone in Healthy Female Subjects of Childbearing Potential

The primary objective of this study is to evaluate the effects of multiple doses of **obefazimod** on a combined oral contraceptive, specifically ethinyl estradiol/drospirenone, in healthy female participants of childbearing potential. This investigation is clinically relevant as it aims to determine any potential interactions between obefazimod and oral contraceptives, which could impact contraceptive efficacy and safety. Understanding these interactions is crucial for ensuring the safe use of obefazimod in women who are using oral contraceptives.

The clinical trial involves **healthy female participants of childbearing potential**. The study population is exclusively female, with an age range corresponding to category code 3, which typically includes adults. The trial does not include male participants and is focused on a vulnerable population. The sponsor has not provided information regarding the total number of participants. Participants were selected based on their health status and potential for childbearing, although specific inclusion or exclusion criteria have not been disclosed. Lifestyle considerations such as diet, physical activity, or habits have not been specified in the available data.

The clinical trial is designed to evaluate the effects of multiple doses of **obefazimod** on a combined oral contraceptive, specifically ethinyl estradiol/drospirenone, in healthy female participants of childbearing potential. This study is a Phase 3 trial, which is typically conducted to confirm the efficacy and monitor the side effects of a treatment in a larger patient group. The trial follows a randomized, double-blind, controlled design to ensure the reliability and validity of the results. The estimated recruitment start date is August 1, 2023, with an anticipated end date of July 31, 2024, indicating a total trial duration of approximately one year.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to assess eligibility based on predefined criteria. This initial visit will involve a comprehensive evaluation to ensure participants meet the necessary health standards for inclusion in the study. Following successful screening, participants will be randomly assigned to receive either the investigational product or a control, with neither the participants nor the investigators aware of the group assignments, maintaining the double-blind nature of the trial.

Throughout the study, participants will attend regular follow-up visits to monitor their health status, adherence to the study protocol, and any potential side effects. These visits are crucial for collecting data on the primary and secondary endpoints of the trial. The end-of-study visit will mark the conclusion of the participant's involvement, during which final assessments will be conducted to gather comprehensive data on the treatment's effects.

The expected length of participant involvement is contingent upon the trial's schedule, with each participant's duration determined by the time of their enrollment relative to the trial's end date. Conditions that may lead to early termination from the study include non-compliance with the study protocol, adverse events that compromise participant safety, or withdrawal of consent by the participant. The trial's design and procedures are structured to ensure the collection of high-quality data while prioritizing participant safety and ethical standards.

The clinical trial involves the administration of an **experimental medication**. However, specific details regarding the name, pharmaceutical form, dosage, route, and frequency of administration of the experimental medication are not provided in the available data. The trial documentation does not specify whether the medication is a **paediatric formulation** or if it is classified as an **orphan drug**. Additionally, there is no information on the maximum daily dose, total dose, or treatment period for the experimental medication.

In addition to the experimental medication, the trial may include the use of **non-experimental treatments** such as standard-of-care therapy, placebo, or comparator treatments. However, the data does not provide explicit details about these treatments. Information regarding the administration, dosing schedules, and participant compliance monitoring for these non-experimental treatments is also not available.

Due to the lack of specific information in the source data, further details about the **experimental medication** and any **non-experimental treatments** cannot be provided. The trial documentation should be consulted for comprehensive information regarding the treatments used in this clinical trial.

The clinical trial is designed to assess efficacy in a Phase 3 study. The trial is scheduled to begin recruitment on August 1, 2023, and is estimated to conclude by July 31, 2024. The efficacy assessment will be conducted through a series of planned evaluations, although specific parameters or endpoints for efficacy evaluation are not detailed in the available data. The trial will follow a structured timeline to ensure systematic data collection and analysis, adhering to the rigorous standards expected in a Phase 3 clinical trial. The study will utilize validated methods and tools appropriate for the trial phase to ensure the reliability and validity of the efficacy outcomes. The trial's design and execution will align with the regulatory and scientific standards required for this stage of clinical research.