Efficacy of Vitex Agnus-castus BNO 1095 (20 mg) in Women With Primary Dysmenorrhea

Primary Dysmenorrhea Clinical Trial

Official title: Efficacy of Vitex Agnus-castus BNO 1095 (20 mg) in Women With Primary Dysmenorrhea

Status Recruiting

Clinical Trial Summary

In this Phase III study, the herbal product Vitex agnus-castus BNO 1095 20 mg will be tested.

The sponsor would like to find out if treatment with Vitex agnus-castus BNO 1095 20 mg may improve the cramping pain before or during menstruation (primary dysmenorrhea) (without an organic cause) in women and if this treatment is safe. It is tested, if the pelvic pain and other symptoms during menstruation improve in patients who are treated with Vitex agnus-castus BNO 1095 20 mg and if therefore the standard treatments for primary dysmenorrhea, for example pain relief medications will not have to be increased.

The study has 2 treatment groups. Patients in one group will receive Vitex agnus-castus BNO 1095 20 mg, and patients in the other group will receive a placebo. Placebo tablets look like Vitex agnus-castus BNO 1095 20 mg tablets but have no active ingredient. Patients will be randomly assigned (like tossing a coin) to one of the 2 groups (this process is called randomization). The chance for the patients to receive Vitex agnus-castus BNO 1095 is 50%. Neither the patients nor the investigators know which product the patients are taking (this method is known as "double-blind").

Clinical Trial Description

This is a randomized, placebo-controlled, double-blind, multicenter, phase III clinical trial to investigate the efficacy and safety of investigational medicinal product (IMP) Vitex agnus-castus BNO 1095 20 mg in women with primary dysmenorrhea.

The clinical trial will be conducted in Austria, Czech Republic, Germany, Hungary, Poland and Sweden.

About 390 patients will be screened so that about 300 patients (150 patients per treatment group) will be randomized.

Vitex agnus-castus BNO 1095 20 mg is extracted from the fruits of the plant Vitex agnus-castus also called monk's pepper or chaste tree. Vitex agnus-castus BNO 1095 20 mg is currently marketed for the treatment of the premenstrual syndrome (PMS) which means repeated occurrence of physical, behavioral and psychological symptoms the days before the onset of menstruation, but it is not authorized for the treatment of primary dysmenorrhea.

The study has 2 treatment groups. Patients in one group will receive Vitex agnus-castus BNO 1095 20 mg, and patients in the other group will receive a placebo. Patients will be randomly assigned 1:1 to one of the 2 groups. The chance to receive Vitex agnus-castus BNO 1095 is 50%. The study is double blinded, neither the patients nor the investigators know which product the patients are taking.

The study will last about 7 months for each patient. There will be 5 visits at the study site, and in addition the patients will receive 3 phone calls from the study site. On average, each study site visit will take about 2 hours and each phone call about half an hour.

The trial will include 3 phases: a screening and run-in phase of up to 2 menstrual cycles, a treatment phase of 4 menstrual cycles and a follow-up phase of 1 menstrual cycle. The length of each phase depends on the length of women's menstrual cycle. If their menstrual cycle is 28 days, the screening and run-in phase will take up to 59 days (slightly more than 2 menstrual cycles), the treatment phase 113 days (about 4 menstrual cycles), and the follow-up phase 28 days (1 menstrual cycle).

The main objective of this study is to determine if primary dysmenorrhea improves in women treated with Vitex agnus-castus BNO 1095 20 mg compared to placebo over a treatment duration of 3 menstrual cycles (cramping windows of Cycles 3-5).

Vitex agnus-castus BNO 1095 20 mg or placebo tablets are taken orally (means by mouth) once a day during the treatment phase.

If a patient usually takes pain relief medication for primary dysmenorrhea, the patient is allowed to continue taking this pain relief medication during study participation.

The patients will complete the dysmenorrhea daily diary (DysDD) every day in the evening. Depending on her bleeding status, the diary includes questions about menstrual bleeding, pieces of sanitary protection used, severity of the worst pain or cramps in the pelvic area on a numerical rating scale (NRS), intake of pain relief medication, and impact on daily life in an electronic diary (handheld device).

Additionally, the dysmenorrhea associated symptoms nausea, vomiting, diarrhea, fatigue, weakness, fainting, and headache will be assessed by the patients on a NRS in the electronic diary on Days 1-3 of the menstrual cycle. Migraine will be assessed by the investigator at the clinical trial visits. The patient and investigator will assess the efficacy of treatment on a 5-point verbal rating scale at the end of treatment and at the end of the study (EoS). ;

Related Conditions & MeSH terms

• Dysmenorrhea
• Primary Dysmenorrhea

• NCT number: NCT06211049
• Study type: Interventional
• Source: Bionorica SE
• Contact: Kundeninfoservice
• Phone: +49918123190
• Email: info@bionorica.de
• Status: Recruiting
• Phase: Phase 3
• Start date: December 12, 2023
• Completion date: March 31, 2025