Status:
COMPLETED
a Clinical Trial to Evaluate the Efficacy and Safety of Agnucaston Tablets in the Treatment of Premenstrual Syndrome (PMS)
Lead Sponsor:
Schwabe-Wenex International Ltd
Conditions:
Premenstrual Syndrome
Eligibility:
FEMALE
18-45 years
Phase:
PHASE2
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 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...
Eligibility Criteria
Inclusion
- clinical diagnosis of PMS disease
- Age between 18 and 45 years
- Patients is in general good health
Exclusion
- 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.
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2007
Estimated Enrollment :
217 Patients enrolled
Trial Details
Trial ID
NCT00672607
Start Date
February 1 2005
End Date
January 1 2007
Last Update
October 1 2009
Active Locations (1)
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1
Peking Union Medical College Hospital
Beijing, China, 100730