Status:
COMPLETED
Efficacy of Vitex Agnus-castus BNO 1095 (20 mg) in Women With Primary Dysmenorrhea
Lead Sponsor:
Bionorica SE
Collaborating Sponsors:
FGK Clinical Research GmbH
Conditions:
Primary Dysmenorrhea
Eligibility:
FEMALE
18-49 years
Phase:
PHASE3
Brief 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 cr...
Detailed 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 1...
Eligibility Criteria
Inclusion
- Women aged 18-49 years who have the capacity for consenting
- 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 the approved informed consent form (ICF)
- Diagnosed primary dysmenorrhea
- If patients take pain relief medication for primary dysmenorrhea, this medication should be taken unchanged with regard to application form and kind of medication including strength during the Screening as well as during the first three treatment cycles.
- Note: Medication (drugs) for primary dysmenorrhea as mono- or combination therapy in form of tablets/capsules regularly used by the patient before Screening is allowed to be used as standard pain relief medication during the trial apart from non-medication methods. A complete list of allowed pain relief medication is attached to the protocol.
- This medication should be taken by the patient at least for 1 cycle before Screening guaranteeing a stable intake of this medication in total for 3 cycles before randomization.
- Patients with a regular menstrual cycle duration of ≥24 to ≤38 days
- Patients agreeing to use one of the following contraception methods throughout the trial:
- Bilateral tubal occlusion
- Vasectomized partner (provided that the partner is the sole sexual partner of the woman and has received medical assessment of the surgical success)
- Sexual abstinence Abstinence is only accepted as true abstinence when this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods and withdrawal) is not an acceptable method of contraception
- Male or female condom with or without spermicide
- Cap, diaphragm, or sponge with spermicide
Exclusion
- A patient will not be eligible for inclusion if any of the following criteria applies:
- Non-menstruating women
- Clinically diagnosed secondary dysmenorrhea (e.g., fibroids, uterine adenomyosis, endometriosis, pelvic inflammation, ovarian pathologies, or other pelvic diseases)
- Dysmenorrhea resulting from the use of an intrauterine device
- 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
- 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
- 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
- Known or suspected gynecological complaints e.g., premenstrual abdominal pain, deep dyspareunia, uterine fibroids and polyps, or chronic pain (abdominal, dorsal, urogenital)
- Known instable diseases e.g., psychiatric, cardiovascular, or endocrine disorders
- Body mass index \<18.5 or \>34.9 kg/m² at Screening
- Known or suspected acute infection of gonorrhea, syphilis and/or chlamydia at Screening
- Current or past estrogen sensitive cancer or pituitary disorder that, in the investigator's opinion, would make the patient not suitable for the trial
- Women who are breastfeeding, pregnant (positive pregnancy test at Screening), or planning to become pregnant during the trial
- Fewer than 3 menstrual cycles before Screening following delivery, abortion, miscarriage, or lactation
- Current severe physical or mental illness
- Patient does not agree to avoid daily smoking
- 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
- Patients with hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption
- Hypersensitivity to Vitex agnus-castus, lactose or any of the excipients of the IMP or to any ingredients of the standard pain relief medication
- Patients committed to an institution by virtue of an order issued either by the judicial or the administrative authorities
- Employees of the sponsor or site staff or direct relatives of the site staff
- Legal incapacity or limited legal capacity
- 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
- Participation in another interventional clinical trial during the last month before Screening
- Use of Vitex agnus-castus containing preparation or product within the last 3 months before Screening
- 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
Key Trial Info
Start Date :
December 12 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 23 2025
Estimated Enrollment :
335 Patients enrolled
Trial Details
Trial ID
NCT06211049
Start Date
December 12 2023
End Date
July 23 2025
Last Update
July 28 2025
Active Locations (34)
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1
Medizinische Universität Innsbruck, Department Frauenheilkunde, Universitätsklinik für Gynäkologische Endokrinologie und Reproduktionsmedizin
Innsbruck, Austria, 6020
2
Medizinische Universität Wien, Universitätsklinik für Frauenheilkunde, Klinische Abteilung für Gynäkologische Endokrinologie und Reproduktionsmedizin
Vienna, Austria, 1090
3
Centrum ambulantní gynekologie a primární péče s.r.o.
Brno střed, Czechia, 60200
4
Fakultní nemocnice Brno, Gynekologickoporodnická Klinika, Centrum asistované reprodukce CAR 01 Brno
Brno střed, Czechia, 60200