Study on the Effectiveness of Chaste Tree Extract (Vitex agnus-castus BNO 1095) for Women with Menstrual Cramps (Primary Dysmenorrhea)

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What is this study about?

This clinical trial is focused on studying the effects of a treatment for primary dysmenorrhea, which is a condition characterized by cramping pain in the lower abdomen that occurs just before or during menstruation. The treatment being tested is a herbal medicine called Vitex agnus-castus BNO 1095, which is derived from the chaste tree fruit. The study aims to determine if this treatment can help reduce the symptoms of primary dysmenorrhea in women.

Participants in the study will be randomly assigned to receive either the Vitex agnus-castus BNO 1095 treatment or a placebo. The study will last for three menstrual cycles, during which the effectiveness of the treatment will be assessed. The goal is to see if there is an improvement in the cramping pain experienced by participants who take the herbal medicine compared to those who receive the placebo.

The study will monitor the participants’ symptoms over the course of the treatment period to evaluate any changes in their condition. The main focus is to observe a reduction in the peak pelvic pain score and to ensure that there is no increase in the use of standard pain relief medication during the treatment. This trial is designed to provide valuable information on whether Vitex agnus-castus BNO 1095 can be an effective option for managing primary dysmenorrhea.

1 joining the study

Upon joining the study, the patient is informed about the nature, scope, and relevance of the clinical trial. The patient voluntarily agrees to participate and signs the informed consent form.

2 treatment phase

The patient receives either Vitex agnus-castus BNO 1095 (20 mg) or a placebo. The treatment is administered orally.

The treatment duration is over three menstrual cycles, specifically during the cramping windows of Cycles 3 to 5.

3 medication use

If the patient uses pain relief medication for primary dysmenorrhea, it should remain unchanged in terms of type and strength. This medication can be used as standard pain relief during the trial.

4 evaluation of treatment response

The primary goal is to assess if there is a reduction of at least 3 points in the peak pelvic pain score during the cramping window of Cycle 5 compared to the baseline.

Additionally, there should be no increase in the number of standard pain relief medications taken during the cramping window of Cycle 5 compared to the baseline.

Who Can Join the Study?

  • Women aged 18-49 years who are able to give their consent to participate.
  • The patient must be informed about the clinical trial, agree to participate voluntarily, and sign the informed consent form.
  • The patient must have been diagnosed with primary dysmenorrhea, which means experiencing painful menstrual cramps.
  • If the patient takes pain relief medication for primary dysmenorrhea, they should continue using the same type and strength of medication as before the trial.
  • The patient must have a regular menstrual cycle lasting between 24 to 38 days.
  • The patient must agree to use one of the following contraception methods during the trial:
    • Bilateral tubal occlusion (a surgical procedure to block the fallopian tubes).
    • A partner who has had a vasectomy (a surgical procedure for male sterilization) and is the only sexual partner.
    • Sexual abstinence, meaning not having sexual intercourse, if it is the patient’s usual lifestyle.
    • Using a male or female condom, with or without spermicide (a substance that kills sperm).
    • Using a cap, diaphragm, or sponge with spermicide.

Who Cannot Join the Study?

  • Women who are not experiencing primary dysmenorrhea cannot participate. Primary dysmenorrhea refers to painful menstrual cramps that occur in the absence of any other medical condition.
  • Men cannot participate in this study.
  • Individuals who are not within the specified age range for the study cannot participate. The age range is not specified here, but it is important to be within the required age group.
  • Participants who are considered part of a vulnerable population may be excluded. Vulnerable populations include groups who may have limited ability to give informed consent or are at higher risk of harm.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Praxis Geseke Geseke Germany
Medical University Of Vienna Vienna Austria
Klinische Forschung Karlsruhe GmbH Karlsruhe Germany
Medizinische Universitaet Innsbruck Innsbruck Austria
Gyncare MUDr. Michael Svec s.r.o. Plzen 2-Slovany Czechia

Other Sites

Site Name City Country Status
IPR Hungary Kft. Miskolc Hungary
Axon Kft. Kecskemet Hungary
Clinexpert Kft. Budapest Hungary
Praxis für Gynäkologie und Geburtshilfe Bernburg Germany
Obudai Egeszseguegyi Centrum Kft. Dunaújváros Hungary
Fakultni Nemocnice U Sv Anny V Brne Brno-Stred Czechia
Danderyds Sjukhus AB Danderyd Sweden
HELIOS Kliniken Schwerin GmbH Schwerin Germany
Klinische Forschung Hannover-Mitte GmbH Hanover Germany
Klinische Forschung Berlin-Mitte GmbH Berlin Germany
Klinische Forschung Hamburg GmbH Hamburg Germany
Centrum Badawcze Panaceum Agnieszka Brzezicka Magdalena Lenkiewicz Sp. z o.o. Malbork Poland
Centra Medyczne Medyceusz Sp. z o.o. Lodz Poland
Silmedic Sp. z o.o. Katowice Poland
NEUMED gynekologicka ambulance s.r.o. Olomouc Czechia
BKS Research Kft. Hatvan Hungary
Centrum gynekologicke rehabilitace s.r.o. Písek Czechia
GYNEKOLOGIE Cheb s.r.o. Cheb Czechia
Paqhitlgh Iopurkvb Mueccdep Mzsqypxbzcbg Sdjnw Whlhszdjpifw I Aurejcqhmsnkf Warsaw Poland
Zjhmb Mma Kzfq Debrecen Hungary
Nrdo Pdxieukhf Lublin Poland
Mrzjm Mpgctcn Mqolkjst Rnjurswufitq swxkpv Plzen Czechia
Mbvus Liwrzgo Mdcmelvif &upgiuq Uslmy ndr Lfdh Prague Czechia
Kgjerjupzs Utforlitme Hyqlbggvn Wigkemgcey Stockholm Sweden
Ppibni Djcimdftsop Bmnbrai Ilsede Germany
Pkckla Dqc Nfrt Aachen Germany
Fzhvlhzyzu ic Salwvksn – Wsvwyfva Cdjovjw Stolberg Germany
Cilsvpx Mhncckfr Mnvmrdroqq du Awwu Shiqufvc Katowice Poland
Kwqlkpcat Flpsduobg Deffqlk Gqqo Dresden Germany
Cmhaiyp ahcqlfzdzx gzfqrjdcytq a pkcaixnu pxzp sgktky Brno-Stred Czechia
Ptyywq Dlt Pfkfpu Hamburg Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
01.10.2023
Czechia Czechia
Not recruiting
01.10.2023
Germany Germany
Not recruiting
01.10.2023
Hungary Hungary
Not recruiting
01.10.2023
Poland Poland
Not recruiting
01.10.2023
Sweden Sweden
Not recruiting
01.10.2023

Trial locations

Vitex agnus-castus BNO 1095 is a herbal medication being studied for its potential to relieve symptoms of primary dysmenorrhea, which is a condition characterized by painful menstrual cramps. The trial aims to determine if this medication can improve the condition in women over the course of three menstrual cycles.

Primary Dysmenorrhea – This condition is characterized by painful menstrual cramps that occur just before or during menstruation. It is caused by the contraction of the uterus, which can lead to pain in the lower abdomen, back, and thighs. The pain can range from mild to severe and may be accompanied by other symptoms such as nausea, fatigue, and headaches. The discomfort typically begins a day or two before menstruation and can last for several days. It is a common condition among women, especially during adolescence and early adulthood. The severity of symptoms can vary from cycle to cycle.

Trial ID:
2023-503688-41-00
Protocol code:
AgnoMed
NCT ID:
NCT06211049
Trial Phase:
Therapeutic confirmatory (Phase III)

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