NCT00672607

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
217

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Feb 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2005

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

May 4, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 6, 2008

Completed
Last Updated

October 1, 2009

Status Verified

September 1, 2009

Enrollment Period

1.9 years

First QC Date

May 4, 2008

Last Update Submit

September 30, 2009

Conditions

Premenstrual Syndrome

Keywords

premenstual syndrome, PMS, clinical trial

Outcome Measures

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.

    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.

    on the 1st-3nd day of menstrual bleeding

Study Arms (2)

1

EXPERIMENTAL
Drug: extracts of Vitex agnus castus tablets

2

PLACEBO COMPARATOR
Drug: Placebo

Interventions

extracts of Vitex agnus castus tabletsDRUG

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

Also known as: Agnucaston tablets
1
PlaceboDRUG

Placebo

2

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • clinical diagnosis of PMS disease
  • Age between 18 and 45 years
  • Patients is in general good health

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, 100730, China

Location

MeSH Terms

Conditions

Premenstrual Syndrome

Condition Hierarchy (Ancestors)

Menstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 4, 2008

First Posted

May 6, 2008

Study Start

February 1, 2005

Primary Completion

January 1, 2007

Study Completion

January 1, 2007

Last Updated

October 1, 2009

Record last verified: 2009-09

Locations

CN(1)