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

Exclusion Criteria

• •A patient will not be eligible for inclusion if any of the following criteria applies:
• •1. Non-menstruating women
• •2. Clinically diagnosed secondary dysmenorrhea (e.g., fibroids, uterine adenomyosis, endometriosis, pelvic inflammation, ovarian pathologies, or other pelvic diseases)
• •3. Dysmenorrhea resulting from the use of an intrauterine device
• •4. Use of hormonal contraceptives (oral, intravaginal, transdermal, injectable, implantable), intrauterine device, or intrauterine hormone-releasing system within 6 months prior to the trial and not willing to waive it during the entire trial period
• •5. Any surgical treatments in the past (e.g., due to myoma) that may cause pain, adhesions or scarring in the lower abdomen Note: Further diagnostic examination (e.g., laparoscopy for differential diagnosis, exclusion of endometriosis) if deemed necessary by the investigator will be outside the trial protocol and reimbursement
• •6. Known or suspected gastrointestinal or urological conditions that may cause abdominal and/or pelvic pain, such as colitis, appendicitis, irritable bowel syndrome, cholelithiasis, interstitial cystitis, cystitis, urolithiasis, and other conditions that, according to the investigator's judgement, are not suitable for the trial
• •7. Known or suspected gynecological complaints e.g., premenstrual abdominal pain, deep dyspareunia, uterine fibroids and polyps, or chronic pain (abdominal, dorsal, urogenital)
• •8. Known instable diseases e.g., psychiatric, cardiovascular, or endocrine disorders
• •9. Body mass index \<18.5 or \>34.9 kg/m² at Screening
• •10. Known or suspected acute infection of gonorrhea, syphilis and/or chlamydia at Screening
• •11. Current or past estrogen sensitive cancer or pituitary disorder that, in the investigator's opinion, would make the patient not suitable for the trial
• •12. Women who are breastfeeding, pregnant (positive pregnancy test at Screening), or planning to become pregnant during the trial
• •13. Fewer than 3 menstrual cycles before Screening following delivery, abortion, miscarriage, or lactation
• •14. Current severe physical or mental illness
• •15. Patient does not agree to avoid daily smoking
• •16. History of alcohol, drug, or medicine abuse within 1 year prior to Screening, or positive for drugs or medicines of abuse in the laboratory analysis performed at Screening
• •17. Patients with hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption
• •18. Hypersensitivity to Vitex agnus-castus, lactose or any of the excipients of the IMP or to any ingredients of the standard pain relief medication
• •19. Patients committed to an institution by virtue of an order issued either by the judicial or the administrative authorities
• •20. Employees of the sponsor or site staff or direct relatives of the site staff
• •21. Legal incapacity or limited legal capacity
• •22. Patients not able to follow trial instructions or assessments or to participate in the trial for the whole duration of approximately 7 months or unable to understand written and verbal instruction, in particular regarding the risks and inconveniences that the patients will be exposed to during participation in the clinical trial
• •23. Participation in another interventional clinical trial during the last month before Screening
• •24. Use of Vitex agnus-castus containing preparation or product within the last 3 months before Screening
• •25. Current intake or intake within the last 4 weeks before Screening of dopamine agonists, dopamine antagonists, estrogens, or antiestrogens that would make the patient not suitable for the trial