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a Clinical Trial to Evaluate the Efficacy and Safety of Agnucaston Tablets in the Treatment of Premenstrual Syndrome (PMS) (ACT-RCT-C 01)

This study has been completed.
Sponsor:
Information provided by:
Schwabe-Wenex International Ltd
ClinicalTrials.gov Identifier:
NCT00672607
First received: May 4, 2008
Last updated: September 30, 2009
Last verified: September 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Premenstrual Syndrome
 Drug: extracts of Vitex agnus castus tablets
Drug: Placebo
 Phase 2

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Schwabe-Wenex International Ltd:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 217
Study Start Date: February 2005
Study Completion Date: January 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 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 Name: Agnucaston tablets
Placebo Comparator: 2 Drug: Placebo
Placebo

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 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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00672607

Locations
China
Peking Union Medical College Hospital
Beijing, China, 100730
Sponsors and Collaborators
Schwabe-Wenex International Ltd
  More Information

No publications provided

Responsible Party: Helen Guo, Schwabe-Wenex
ClinicalTrials.gov Identifier: NCT00672607     History of Changes
Other Study ID Numbers: Schwabe-Wenex
Study First Received: May 4, 2008
Last Updated: September 30, 2009
Health Authority: China: Food and Drug Administration

Keywords provided by Schwabe-Wenex International Ltd:
premenstual syndrome, PMS, clinical trial

Additional relevant MeSH terms:
Premenstrual Syndrome
Menstruation Disturbances
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013