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Efficacy of Vitex agnus-castus BNO 1095 (20 mg) in women with primary dysmenorrhea

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-503688-41-00
Acronym
AgnoMed
Enrollment
300
Registered
2023-11-20
Start date
2023-11-28
Completion date
2025-07-23
Last updated
2025-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Dysmenorrhea

Brief summary

Proportion of patients who respond to treatment defined as: a) a ≥3-point reduction in the peak pelvic pain score assessed in the cramping window of Cycle 5 compared to Baseline AND b) no increase in the number of standard pain relief medication taken in the cramping window of Cycle 5 compared to Baseline.

Interventions

DRUGPlacebo
DRUGDRY EXTRACT FROM CHASTE TREE FRUITS (7-11:1)
DRUGEXTRACTION SOLVENT: ETHANOL 70% (V/V)

Sponsors

Bionorica SE
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
Proportion of patients who respond to treatment defined as: a) a ≥3-point reduction in the peak pelvic pain score assessed in the cramping window of Cycle 5 compared to Baseline AND b) no increase in the number of standard pain relief medication taken in the cramping window of Cycle 5 compared to Baseline.

Countries

Austria, Czechia, Germany, Hungary, Poland, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026