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

NCT06211049 | Completed Phase 3

• 3 other identifiers: AgnoMed2023-503688-41-00U1111-1288-9484
• Study Type: interventional
• Target: 335
• Locations: 6 countries
• Sites: 34

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 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").

Conditions

Primary Dysmenorrhea

Keywords

Vitex agnus-castus; Menstrual pain

Outcome Measures

Primary Outcomes (1)

• Proportion of patients who respond to treatment defined as: a) a ≥3-point reduction in the peak pelvic pain score and b) no increase in the number of standard pain relief medication

  Response to treatment will be determined by comparing the peak pelvic pain score (using an 11-point numeric rating scale (NRS, scale ranging from 0 (no symptom) to 10 (extreme severity of symptom) of the dysmenorrhea daily diary (DysDD) assessments) made during the cramping window of Cycle 5 with those made at Baseline and by comparing the assessments of number of tablets or capsules of standard pain relief medication taken during the cramping window of Cycle 5 with those taken at Baseline.

  Change from Baseline (28 days prior to randomization) to the cramping window of Cycle No. 5 (each cycle is 28 days). The cramping window is defined as Days -1 to 3 of a menstrual cycle (i.e., 4 days in total).

Secondary Outcomes (20)

• Proportion of patients who respond to treatment defined as: a) a ≥3-point reduction in the peak pelvic pain score and b) no increase in the number of standard pain relief medication in the cramping window of Cycles 3, 4, and 6 compared to Baseline

  Change from Baseline (28 days prior to randomization) to the cramping windows of Cycles No. 3, 4 and 6 (each cycle is 28 days). The cramping window is defined as Days -1 to 3 of a menstrual cycle (i.e., 4 days in total).

• Proportion of patients with a ≥3-point reduction in the peak pelvic pain score and a decrease in the number of standard pain relief medication

  Change from Baseline (28 days prior to randomization) to the cramping windows of Cycles No. 3, 4, 5 and 6) (each cycle is 28 days). The cramping window is defined as Days -1 to 3 of a menstrual cycle (i.e., 4 days in total).

• Proportion of patients with a peak pelvic pain score of "0" or "1" and no use of standard pain relief medication

  At the cramping windows of Cycles No. 3, 4, 5 and 6) (each cycle is 28 days). The cramping window is defined as Days -1 to 3 of a menstrual cycle (i.e., 4 days in total).

• Assessment of change of peak pelvic pain score

  Change from Baseline (28 days prior to randomization) to the cramping windows of Cycles No. 3, 4, 5 and 6) (each cycle is 28 days). The cramping window is defined as Days -1 to 3 of a menstrual cycle (i.e., 4 days in total).

• Assessment of the sum of the pelvic pain scores

  At the cramping windows of Cycles No. 3, 4 and 5 (each cycle is 28 days). The cramping window is defined as Days -1 to 3 of a menstrual cycle (i.e., 4 days in total).

Other Outcomes (17)

• Proportion of patients with treatment-emergent adverse events (TEAEs), TEAEs related to the IMP, serious TEAEs related to the IMP, and TEAEs leading to premature discontinuation of the IMP

  From Baseline (28 days prior to randomization) until Visit 5 (Day 141).

• Assessment of change in safety laboratory parameters analyzed from blood samples (hematology)

  Change from Baseline (28 days prior to randomization) to Visit 4 (Day 113).

• Assessment of change in safety laboratory parameters analyzed from blood samples (biochemistry)

  Change from Baseline to (28 days prior to randomization) Visit 4 (Day 113).

Study Arms (2)

Vitex agnus-castus BNO 1095 (20 mg)

EXPERIMENTAL

1 tablet once daily for about 4 menstrual cycles (cramping windows of Cycles 3-6) (i.e., 113 days in case of a 28-day menstrual cycle).

Drug: Vitex agnus-castus BNO 1095 (20 mg)

Placebo

PLACEBO COMPARATOR

1 tablet once daily for about 4 menstrual cycles (cramping windows of Cycles 3-6) (i.e., 113 days in case of a 28-day menstrual cycle).

Drug: Placebo

Interventions

Vitex agnus-castus BNO 1095 (20 mg) DRUG

1 tablet once daily for about 4 menstrual cycles (cramping windows of Cycles 3-6) (i.e.,113 days in case of a 28-day menstrual cycle).

Vitex agnus-castus BNO 1095 (20 mg)

Placebo DRUG

1 tablet once daily for about 4 menstrual cycles (cramping windows of Cycles 3-6) (i.e.,113 days in case of a 28-day menstrual cycle).

Placebo

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Bionorica SE: lead
• FGK Clinical Research GmbH: collaborator

Study Sites (34)

Medizinische Universität Innsbruck, Department Frauenheilkunde, Universitätsklinik für Gynäkologische Endokrinologie und Reproduktionsmedizin

Innsbruck, 6020, Austria

Location

Medizinische Universität Wien, Universitätsklinik für Frauenheilkunde, Klinische Abteilung für Gynäkologische Endokrinologie und Reproduktionsmedizin

Vienna, 1090, Austria

Location

Centrum ambulantní gynekologie a primární péče s.r.o.

Brno-střed, 60200, Czechia

Location

Fakultní nemocnice Brno, Gynekologickoporodnická Klinika, Centrum asistované reprodukce CAR 01 Brno

Brno-střed, 60200, Czechia

Location

GYNEKOLOGIE CHEB s.r.o.

Cheb, 35002, Czechia

Location

NEUMED gynekologická ambulance s.r.o

Olomouc, 77900, Czechia

Location

MUDr. Martina Marešová Rosenbergová s.r.o.

Pilsen, 30100, Czechia

Location

Centrum gynekologické rehabilitace s.r.o

Písek, 39701, Czechia

Location

Gyncare MUDr. Michael Švec s.r.o.

Plzeň 2-Slovany, 32600, Czechia

Location

Praxis Dr. Noel

Aachen, 52072, Germany

Location

Klinische Forschung Berlin-Mitte GmbH

Berlin, 10117, Germany

Location

Frauenarztpraxis Dipl. med. Andrea Heweker, Praxis für Gynäkologie

Bernburg, 06406, Germany

Location

Klinische Forschung Dresden GmbH

Dresden, 01069, Germany

Location

Praxis Geseke

Geseke, 59590, Germany

Location

Frauenarztpraxis Dr. Inka Kiesche

Halle, 06110, Germany

Location

Klinische Forschung Hamburg GmbH

Hamburg, 20253, Germany

Location

Frauenarzt-Praxis Dr. med. Klaus Peters

Hamburg, 22159, Germany

Location

Klinische Forschung Hannover Mitte GmbH

Hanover, 30159, Germany

Location

Klinische Forschung Karlsruhe GmbH

Karlsruhe, 76137, Germany

Location

Klinische Forschung Schwerin GmbH

Schwerin, 19055, Germany

Location

Frauenarzt in Stolberg - Wolfgang Clemens

Stolberg, 52222, Germany

Location

Clinexpert Kft.

Budapest, 1033, Hungary

Location

Óbudai Egészségügyi Centrum Kft.

Budapest, 1036, Hungary

Location

Zatik Med Kft.

Debrecen, 4024, Hungary

Location

BKS Research Kft.

Hatvan, 3000, Hungary

Location

AXON Kereskedelmi Es Szolgaltato Kft.

Kecskemét, 6000, Hungary

Location

IPR Hungary Kft.

Miskolc, 3530, Hungary

Location

Centrum Medyczne Mikołowska dr Adam Sipiński

Katowice, 40-065, Poland

Location

Silmedic Sp. z o.o.

Katowice, 40-282, Poland

Location

Nzoz Profi-Med

Lublin, 20-880, Poland

Location

Centrum Badawcze Panaceum Agnieszka Brzezicka, Magdalena Lenkiewicz Sp. z o.o.

Malbork, 82-200, Poland

Location

Państwowy Instytut Medyczny Ministerstwa Spraw Wewnętrznych i Administracji, Klinika Położnictwa, Chorób Kobiecych i Ginekologii Onkologicznej

Warsaw, 02-507, Poland

Location

Karolinska University Hospital, WHO-centre

Stockholm, SE-171 76, Sweden

Location

Umeå University, Dep. of Clinical Sciences, Obstetrics and Gynecology

Umeå, SE-907 37, Sweden

Location

MeSH Terms

Conditions

Dysmenorrhea

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Petra Stute, Prof. Dr.

  Universitätsklinik für Frauenheilkunde, Inselspital Bern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: randomized, double-blind, multicenter, placebo-controlled

Study Record Dates

• First Submitted: November 23, 2023
• First Posted: January 18, 2024
• Study Start: December 12, 2023
• Primary Completion: July 23, 2025
• Study Completion: July 23, 2025
• Last Updated: July 28, 2025

Record last verified: 2025-07

Locations

PL (5); AU (2); DE (12); HU (6); SE (2); CZ (7)