Status:

COMPLETED

Vitamin K Injections for the Treatment of Painful Menstruation

Lead Sponsor:

National Center for Complementary and Integrative Health (NCCIH)

Conditions:

Dysmenorrhea

Eligibility:

FEMALE

14-25 years

Phase:

PHASE1

Brief Summary

The purpose of this study is to test the feasibility and effectiveness of vitamin K injections into certain body parts for the treatment of painful menstruation.

Detailed Description

Painful menstruation, also known as dysmenorrhea, is a common problem affecting a significant percentage of women. In the United States and Europe, nonsteroidal anti-inflammatory drugs (NSAIDs) and or...

Eligibility Criteria

Inclusion

  • Dysmenorrhea for at least 6 months prior to study entry
  • Have never been pregnant or have given birth
  • Mandarin Chinese or Shanghainese speaking
  • Regular menstrual cycles for at least 6 months prior to diagnosis of dysmenorrhea
  • Has a working home phone or cellular phone
  • Willing to disclose address
  • Intends to stay in the area during the study
  • Parent or guardian willing to provide informed consent, if applicable

Exclusion

  • Dysmenorrhea due to any suspected or recognized causes
  • Current use of hormonal contraceptives or an intrauterine device
  • History of abdominal surgery
  • Other concomitant therapy for acute or chronic pain
  • Anticoagulant drugs
  • Vitamin K acu-injections at leg acupuncture points prior to study entry
  • Intolerance to NSAIDs
  • Known allergy to vitamin K

Key Trial Info

Start Date :

September 1 2004

Trial Type :

INTERVENTIONAL

End Date :

March 1 2006

Estimated Enrollment :

36 Patients enrolled

Trial Details

Trial ID

NCT00104546

Start Date

September 1 2004

End Date

March 1 2006

Last Update

January 25 2008

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Menstrual Disorder Clinic of the OBS/GYN Hospital of Fudan University

Shanghai, China