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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title:

Brief 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 Summary: 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.
Sponsor: Schwabe-Wenex International Ltd

Current Primary Outcome: Change from baseline (cycle 0) of premenstrual complaints, assessed by the sum score of the 18 items of the PMS-Diary, after 3 cycles under treatment, evaluated for the luteal phase, i.e. the last 7 days prior a menstrual bleeding. [ Time Frame: the last 7 days prior a menstrual bleeding ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Change from baseline (cycle 0) of the sum score of the 36 questions of the PMTS self-assessment scale after 3 cycles under treatment. [ Time Frame: on the 1st-3nd day of menstrual bleeding ]

Original Secondary Outcome: Same as current

Information By: Schwabe-Wenex International Ltd

Dates:
Date Received: May 4, 2008
Date Started: February 2005
Date Completion:
Last Updated: September 30, 2009
Last Verified: September 2009