Trial | NCT00672607  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    217
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.
Study Started
Feb 28
2005
Primary Completion
Jan 31
2007
Study Completion
Jan 31
2007
Last Update
Oct 01
2009
Estimate

Drug extracts of Vitex agnus castus tablets

orally, one tablet daily. Apply for a period of 3 months. Do not interrupt during menses period.

  • Other names: Agnucaston tablets

Drug Placebo

Placebo

1 Experimental

2 Placebo Comparator

Criteria 

Inclusion Criteria:

clinical diagnosis of PMS disease
Age between 18 and 45 years
Patients is in general good health

Exclusion Criteria:

Any of the following endocrinological diseases: diabetes mellitus, hypo-/hyperthyreosis, pituitary tumor.
Clearly kidney or liver disease, abnormal kidney or liver function.
Any of the following gynecological diseases: endometriosis, mammary carcinoma, intraductal papilloma, galactorrhea, mammary fibroadenoma.
Prior to the start of the study any planned surgical intervention of the breasts (including cyst puncture), of the uterus and/ or adnexa.
No Results Posted