A Phase 2 interventional study of extracts of Vitex agnus castus tablets and Placebo in Premenstrual Syndrome, sponsored by Schwabe-Wenex International Ltd. Completed at 1 site in China. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2009-10-01.
Sponsored by Schwabe-Wenex International Ltd · Phase 2, Interventional, and Treatment
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.
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.
9,217 studies on the registry are indexed under Syndrome; 1,031 are open to participants now.
This study's enrollment of 217 is above the median of 50 across 6,515 interventional studies indexed under Syndrome.
Browse Syndrome studies →This is the only study on the registry with Schwabe-Wenex International Ltd as lead sponsor.
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Exclusion Criteria:
Drug: extracts of Vitex agnus castus tablets
Drug: Placebo
orally, one tablet daily. Apply for a period of 3 months. Do not interrupt during menses period.
Also known as: Agnucaston tablets
Placebo
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
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
This study is completed, as verified in Sep 2009. You cannot join it, but the record below documents what was studied.
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