NCT00672607

a Clinical Trial to Evaluate the Efficacy and Safety of Agnucaston Tablets in the Treatment of Premenstrual Syndrome (PMS)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 217 (actual)
• Sponsor: Schwabe-Wenex International Ltd · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

To compare the efficacy and safety of Agnucaston tablets with placebo for the treatment of Premenstrual Syndrome (PMS) and assess if Agnucaston tablets are superior to placebo on efficacy or not.

Detailed description

Premenstrual syndrome (PMS) is a common disorder in women and consists of somatic and/or behavioral/mood symptoms, which can impair a woman's social and work-related functioning. Some clinical studies with preparations containing Vitex agnus castus have demonstrated a positive effect on PMS with good tolerability. The aim of this clinical trial is to investigate the efficacy and safety of Agnucaston tablets for the therapy of PMS.

Conditions

• Premenstrual Syndrome

Interventions

Type	Name	Description
DRUG	extracts of Vitex agnus castus tablets	orally, one tablet daily. Apply for a period of 3 months. Do not interrupt during menses period.
DRUG	Placebo	Placebo

Timeline

• Start date: 2005-02-01
• Primary completion: 2007-01-01
• Completion: 2007-01-01
• First posted: 2008-05-06
• Last updated: 2009-10-01

Locations

1 site across 1 country: China