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

NCT06211049 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 335

Last updated 2025-07-28

No results posted yet for this study

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

Interventions

DRUG

Vitex agnus-castus BNO 1095 (20 mg)

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

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).

Sponsors & Collaborators

  • FGK Clinical Research GmbH

    collaborator INDUSTRY

  • Bionorica SE

    lead INDUSTRY

Principal Investigators

  • Petra Stute, Prof. Dr. · Universitätsklinik für Frauenheilkunde, Inselspital Bern

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-12
Primary Completion
2025-07-23
Completion
2025-07-23

Countries

  • Austria
  • Czechia
  • Germany
  • Hungary
  • Poland
  • Sweden

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06211049 on ClinicalTrials.gov