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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)

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ClinicalTrials.gov Identifier: NCT00672607
Recruitment Status : Completed
First Posted : May 6, 2008
Last Update Posted : October 1, 2009
Information provided by:
Schwabe-Wenex International Ltd

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.

Condition or disease Intervention/treatment Phase
Premenstrual Syndrome Drug: extracts of Vitex agnus castus tablets Drug: Placebo Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 217 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : February 2005
Primary Completion Date : January 2007
Study Completion Date : January 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00672607

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

Responsible Party: Helen Guo, Schwabe-Wenex
ClinicalTrials.gov Identifier: NCT00672607     History of Changes
Other Study ID Numbers: Schwabe-Wenex
First Posted: May 6, 2008    Key Record Dates
Last Update Posted: October 1, 2009
Last Verified: September 2009

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

Additional relevant MeSH terms:
Premenstrual Syndrome
Pathologic Processes
Menstruation Disturbances