Efficacy of Vitex agnus-castus BNO 1095 in the Management of Primary Dysmenorrhea in Women: A Randomized, Double-Blind, Placebo-Controlled Trial

The primary objective of this study is to evaluate the efficacy of **Vitex agnus-castus** BNO 1095 (20 mg) in improving symptoms of primary dysmenorrhea in women. This will be assessed by comparing the treatment group to a placebo group over a duration of three menstrual cycles, specifically focusing on the cramping windows of Cycles 3-5. The clinical relevance of this objective lies in addressing the significant discomfort and pain associated with primary dysmenorrhea, which affects a substantial number of women and can impact their quality of life. No secondary objectives are specified for this study.

The clinical trial focuses on evaluating the efficacy of **Vitex agnus-castus** BNO 1095 20 mg in women with **primary dysmenorrhea**. The study population comprises women aged 18 to 49 years, exclusively female, with a regular menstrual cycle duration of 24 to 38 days. Participants are required to have the capacity for consenting and must have been informed about the trial's nature, scope, and relevance. The trial does not include male subjects and involves a vulnerable population. Participants are expected to maintain their current pain relief medication regimen for primary dysmenorrhea, if applicable, and adhere to specific contraception methods throughout the trial. The sponsor has not provided information regarding the total number of participants. The selection criteria emphasize the importance of informed consent and the use of consistent pain management strategies during the study period.

The clinical trial is designed to evaluate the efficacy of **Vitex agnus-castus BNO 1095** (20 mg) in women diagnosed with **primary dysmenorrhea**. This study is structured as a randomized, double-blind, placebo-controlled trial, ensuring that neither the participants nor the researchers know who is receiving the active treatment or the placebo, thus minimizing bias. The trial is set to span over a period of three menstrual cycles, specifically targeting the cramping windows of Cycles 3 to 5. Participants will be involved in the study for an estimated duration of 156 days, which includes the treatment period and follow-up assessments.

The sequence of study visits begins with an inclusion (screening) visit, where eligibility is confirmed based on criteria such as age, diagnosis of primary dysmenorrhea, and agreement to use specified contraception methods. Following the screening, participants will undergo baseline assessments before randomization. Subsequent visits will occur at the end of each menstrual cycle to monitor treatment response and adherence. The primary endpoint is defined as a ≥3-point reduction in the peak pelvic pain score during the cramping window of Cycle 5 compared to baseline, without an increase in the use of standard pain relief medication. The end-of-study visit will include a comprehensive evaluation of the treatment's efficacy and safety.

Participants may be withdrawn from the study if they experience adverse effects, fail to comply with the study protocol, or choose to withdraw consent. The trial's primary objective is to determine if treatment with Vitex agnus-castus BNO 1095 results in significant improvement in primary dysmenorrhea symptoms compared to placebo. The study is expected to conclude by April 2025, with recruitment having commenced in October 2023.

The clinical trial involves the administration of **Vitex agnus-castus BNO 1095**, a **dry extract from chaste tree fruits** (7-11:1), with an extraction solvent of ethanol 70% (v/v). This experimental medication is provided in the form of a film-coated tablet. The dosage is set at 20 mg per day, administered orally. The maximum total dose over the treatment period is 2280 mg. The treatment duration is specified as 156 days, corresponding to three menstrual cycles. The investigational medicinal product (IMP) will be packaged and labeled according to regulatory requirements to maintain blinding. Participant compliance will be monitored throughout the study to ensure adherence to the dosing schedule.

The study also includes a **placebo** as a comparator treatment. The placebo is designed to match the experimental medication in appearance but does not contain any active substance. It serves as a control to evaluate the efficacy of the Vitex agnus-castus BNO 1095. The placebo is administered following the same schedule and route as the experimental medication, ensuring that the study remains double-blind. The use of a placebo allows for a rigorous assessment of the treatment's impact on primary dysmenorrhea in the study population.

The efficacy of Vitex agnus-castus BNO 1095 (20 mg) in women with **primary dysmenorrhea** will be assessed through a clinical trial. The primary endpoint for evaluating efficacy is the proportion of patients who respond to treatment. A response is defined as a reduction of at least 3 points in the peak pelvic pain score during the cramping window of Cycle 5 compared to Baseline, without an increase in the number of standard pain relief medications taken during the same period. This assessment will be conducted over a treatment duration of three menstrual cycles, specifically focusing on the cramping windows of Cycles 3 to 5.