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

Schwabe-Wenex International Ltd217 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

217

Conditions

Premenstrual Syndrome

Interventions

extracts of Vitex agnus castus tabletsDRUG

orally, one tablet daily. Apply for a period of 3 months. Do not interrupt during menses period.

PlaceboDRUG

Placebo

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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.

Locations (1)

Peking Union Medical College Hospital

Beijing, China

Outcomes

Primary Outcomes

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 Outcomes

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

Data from ClinicalTrials.gov

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