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

Schwabe-Wenex International

Status and phase

Completed

Phase 2

Conditions

Premenstrual Syndrome

Treatments

Drug: Placebo

Drug: extracts of Vitex agnus castus tablets

Study type

Interventional

Funder types

Industry

Identifiers

NCT00672607

Schwabe-Wenex

Details and patient eligibility

About

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.

Full 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.

Enrollment

217 patients

Sex

Female

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

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.