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

• Status: Completed
• Trial end date: 2007-01-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Schwabe-Wenex International Ltd

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.