Vitamin K Injections for the Treatment of Painful Menstruation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00104546
Recruitment Status : Completed
First Posted : March 2, 2005
Last Update Posted : January 25, 2008
Information provided by:
National Center for Complementary and Integrative Health (NCCIH)

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.

Condition or disease Intervention/treatment Phase
Dysmenorrhea Procedure: Acupuncture point injection of vitamin K Phase 1

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 oral contraceptives are the most commonly prescribed treatments for this condition. However, in China, oral contraceptives are not commonly prescribed for unmarried women. Acu-injection, a procedure involving the injection of vitamin K into acupuncture points, has become standard treatment for dysmenorrhea at many Chinese health care facilities. This trial will assess the willingness of young Chinese women to participate in an acu-injection trial, explore the utility of pain measurements after injection, and determine the effectiveness of the injections. This study will also help in planning larger acu-injection clinical trials.

This study will last for five menstrual cycles. Participants will be randomly assigned to one of three groups. Group 1 participants will receive a vitamin K3 injection in an acupuncture point of both legs and a saline injection in the right buttock. Group 2 participants will receive a saline injection in an acupuncture point of both legs and a saline injection in the right buttock. Group 3 participants will receive a saline injection in a pseudo-acupuncture point of both legs and a vitamin K3 injection in the right buttock. Injections will be administered one time during the first 2 days of the first menstrual cycle for participants who are experiencing menstrual pain. Participants will record their level of menstrual pain before injection and at 2, 5, 30 and 60 minutes after the injections. Participants who do not respond to or are not satisfied with the acu-injection treatment will be offered either Chinese herbal medicine or NSAIDs within 1 hour of the injection. After the injection visit, participants will be asked to complete questionnaires about any menstrual pain or side effects they may be experiencing for five subsequent menstrual cycles.

Study Type : Interventional  (Clinical Trial)
Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Vitamin K Injection Treatment for Primary Dysmenorrhea: A Controlled Pilot Study
Study Start Date : September 2004
Actual Primary Completion Date : March 2006
Actual Study Completion Date : March 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Menadione

Primary Outcome Measures :
  1. Intensity of menstrual pain before and 2, 5, 30, and 60 minutes after treatment by a 10 point Visual Analog Scale (VAS)
  2. presence and severity of recurrences of menstrual pain pre- and post-treatment and in 5 subsequent cycles after therapy
  3. Cox retrospective symptom scale
  4. Moos score

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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 Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00104546

Menstrual Disorder Clinic of the OBS/GYN Hospital of Fudan University
Shanghai, China
Sponsors and Collaborators
National Center for Complementary and Integrative Health (NCCIH)
Principal Investigator: Fredi Kronenberg, PhD Columbia University

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00104546     History of Changes
Other Study ID Numbers: R21AT001957 ( U.S. NIH Grant/Contract )
First Posted: March 2, 2005    Key Record Dates
Last Update Posted: January 25, 2008
Last Verified: January 2008

Keywords provided by National Center for Complementary and Integrative Health (NCCIH):
Vitamin K
Medicine, Chinese Traditional
Pain, Menstrual

Additional relevant MeSH terms:
Menstruation Disturbances
Pathologic Processes
Pelvic Pain
Neurologic Manifestations
Signs and Symptoms
Vitamin K
Growth Substances
Physiological Effects of Drugs
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action