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Completed

NCT Number: NCT00672607

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

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.

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Key information

Conditions

Premenstrual Syndrome Menstruation Disturbances Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Peking Union Medical College Hospital

Beijing, 100730, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

extracts of Vitex agnus castus tablets

Drug

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

Other names: Agnucaston tablets

Placebo

Drug

Placebo

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Schwabe-Wenex International Ltd

Industry

Registry information

Acronym: ACT-RCT-C 01

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
May 6, 2008
Registry last updated
Oct 1, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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