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

Premenstrual Syndrome Clinical Trial

— ACT-RCT-C 01  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00672607
• Other study ID #: Schwabe-Wenex
• Status: Completed
• Phase: Phase 2
• First received: May 4, 2008
• Last updated: September 30, 2009
• Start date: February 2005
• Est. completion date: January 2007

Study information

• Verified date: September 2009
• Source: Schwabe-Wenex International Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 217
• Est. completion date: January 2007
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Premenstrual Syndrome

Intervention

Drug:
• extracts of Vitex agnus castus tablets
orally, one tablet daily. Apply for a period of 3 months. Do not interrupt during menses period.
• Placebo
Placebo

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Schwabe-Wenex International Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		the last 7 days prior a menstrual bleeding	No
Secondary	Change from baseline (cycle 0) of the sum score of the 36 questions of the PMTS self-assessment scale after 3 cycles under treatment.		on the 1st-3nd day of menstrual bleeding	No