Back to resultsa Clinical Trial to Evaluate the Efficacy and Safety of Agnucaston Tablets in the Treatment of Premenstrual Syndrome (PMS) (ACT-RCT-C 01)
Primary Purpose
Premenstrual Syndrome
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
extracts of Vitex agnus castus tablets
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Premenstrual Syndrome focused on measuring premenstual syndrome, PMS, clinical trial
Eligibility 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.
Sites / Locations
- Peking Union Medical College Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Outcomes
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.
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.
Full Information
NCT ID
NCT00672607
First Posted
May 4, 2008
Last Updated
September 30, 2009
Sponsor
Schwabe-Wenex International Ltd
1. Study Identification
Unique Protocol Identification Number
NCT00672607
Brief Title
a Clinical Trial to Evaluate the Efficacy and Safety of Agnucaston Tablets in the Treatment of Premenstrual Syndrome (PMS)
Acronym
ACT-RCT-C 01
Study Type
Interventional
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
January 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Schwabe-Wenex International Ltd
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premenstrual Syndrome
Keywords
premenstual syndrome, PMS, clinical trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
217 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
extracts of Vitex agnus castus tablets
Other Intervention Name(s)
Agnucaston tablets
Intervention Description
orally, one tablet daily. Apply for a period of 3 months. Do not interrupt during menses period.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
ZIP/Postal Code
100730
Country
China
12. IPD Sharing Statement
Learn more about this trial
a Clinical Trial to Evaluate the Efficacy and Safety of Agnucaston Tablets in the Treatment of Premenstrual Syndrome (PMS)
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