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

Study Overview
=================
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.

Conditions
-----------------
Premenstrual Syndrome

Intervention / Treatment
-----------------
* Drug: extracts of Vitex agnus castus tablets
* Drug: Placebo


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: extracts of Vitex agnus castus tablets<br>* orally, one tablet daily. Apply for a period of 3 months. Do not interrupt during menses period.<br>* Other names: Agnucaston tablets;|
| Placebo Comparator: 2<br> | Drug: Placebo<br>* Placebo<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
premenstual syndrome, PMS, clinical trial