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

Inclusion Criteria:

1. Women aged 18-49 years who have the capacity for consenting

2. Patient has been informed of the nature, scope, and relevance of the clinical trial,voluntary agrees in participation and the trial provisions, and has duly signed theapproved informed consent form (ICF)

3. Diagnosed primary dysmenorrhea

4. If patients take pain relief medication for primary dysmenorrhea, this medicationshould be taken unchanged with regard to application form and kind of medicationincluding strength during the Screening as well as during the first three treatmentcycles. Note: Medication (drugs) for primary dysmenorrhea as mono- or combination therapy inform of tablets/capsules regularly used by the patient before Screening is allowedto be used as standard pain relief medication during the trial apart fromnon-medication methods. A complete list of allowed pain relief medication isattached to the protocol. This medication should be taken by the patient at least for 1 cycle before Screeningguaranteeing a stable intake of this medication in total for 3 cycles beforerandomization.

5. Patients with a regular menstrual cycle duration of ≥24 to ≤38 days

6. Patients agreeing to use one of the following contraception methods throughout thetrial:

7. Bilateral tubal occlusion

8. Vasectomized partner (provided that the partner is the sole sexual partner ofthe woman and has received medical assessment of the surgical success)

9. Sexual abstinence Abstinence is only accepted as true abstinence when this isin line with the preferred and usual lifestyle of the patient. Periodicabstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methodsand withdrawal) is not an acceptable method of contraception

10. Male or female condom with or without spermicide

11. Cap, diaphragm, or sponge with spermicide

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 6months 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 deemednecessary by the investigator will be outside the trial protocol and reimbursement

6. Known or suspected gastrointestinal or urological conditions that may causeabdominal and/or pelvic pain, such as colitis, appendicitis, irritable bowelsyndrome, cholelithiasis, interstitial cystitis, cystitis, urolithiasis, and otherconditions that, according to the investigator's judgement, are not suitable for thetrial

7. Known or suspected gynecological complaints e.g., premenstrual abdominal pain, deepdyspareunia, 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 atScreening

11. Current or past estrogen sensitive cancer or pituitary disorder that, in theinvestigator's opinion, would make the patient not suitable for the trial

12. Women who are breastfeeding, pregnant (positive pregnancy test at Screening), orplanning 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, orpositive for drugs or medicines of abuse in the laboratory analysis performed atScreening

17. Patients with hereditary problems of galactose intolerance, total lactase deficiencyor glucose-galactose malabsorption

18. Hypersensitivity to Vitex agnus-castus, lactose or any of the excipients of the IMPor to any ingredients of the standard pain relief medication

19. Patients committed to an institution by virtue of an order issued either by thejudicial 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 inthe trial for the whole duration of approximately 7 months or unable to understandwritten and verbal instruction, in particular regarding the risks and inconveniencesthat the patients will be exposed to during participation in the clinical trial

23. Participation in another interventional clinical trial during the last month beforeScreening

24. Use of Vitex agnus-castus containing preparation or product within the last 3 monthsbefore Screening

25. Current intake or intake within the last 4 weeks before Screening of dopamineagonists, dopamine antagonists, estrogens, or antiestrogens that would make thepatient not suitable for the trial