Clinical Trials Logo

Clinical Trial Summary

Many women, particularly adolescent women, suffer from painful menstrual cramps, medically referred to as dysmenorrhea. Common treatments for menstrual cramps are non-steroidal anti-inflammatory drugs and oral contraceptives, but both have side effects that limit their use. Injection of vitamin K into an acupuncture point has been used as treatment for dysmenorrhea at the Obstetrics & Gynecology Hospital in Shanghai, China since at least 1985. More research is needed on the effectiveness of this treatment and its acceptability to different women. The objective of this study is to examine the feasibility and effectiveness of acupoint injection of vitamin K1 for the treatment of severe primary dysmenorrhea in the United States. Twenty participants will be randomized to receive either 1) vitamin K1 injection into an acupuncture point at the start of their menstrual cycle followed by a saline injection in a non-acupuncture point two months later or 2) saline injection in a non-acupuncture point followed by vitamin K1 injection into an acupuncture point two months later. The primary outcome measure will be change in pain intensity measured before and after each treatment. Data on other menstrual symptoms will be collected by telephone or a web-based survey. Three additional participants will be recruited to receive vitamin K1 injection into an acupuncture point and have blood samples drawn before and after injection to determine absorption of vitamin K1. The aims of the study are to collect preliminary data on the efficacy and safety of vitamin K1 injected in an acupoint for the treatment of severe primary dysmenorrhea; assess the feasibility and acceptability of the treatment among U.S. women; and test the blood absorption of vitamin K1 following acupoint injection treatment.

The investigators hypothesize that:

1. Vitamin K1 acupoint injection is a safe treatment for women with menstrual pain.

2. Vitamin K1 acupoint injection reduces menstrual pain more than placebo saline injection does.

3. The treatment of vitamin K1 acupoint injection is acceptable to U.S. women.

4. Vitamin K1 is absorbed into the blood thru acupoint injection.


Clinical Trial Description

n/a


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00995917
Study type Interventional
Source University of California, San Francisco
Contact
Status Completed
Phase N/A
Start date October 2009
Completion date July 2011

See also
  Status Clinical Trial Phase
Completed NCT04607382 - Survey on Menstrual Symptoms, Health Related Quality of Life and Work Productivity in Patients Suffering From Pain During Menstruation (Dysmenorrhea) in Japan
Recruiting NCT04091789 - Sublingual Tablets With Cannabinoid Combinations for the Treatment of Dysmenorrhea Phase 2
Completed NCT00769964 - VA111913 TS: First in Human Study Phase 1
Completed NCT00746096 - Efficacy and Safety Study of Low Dose Oral Contraceptive Pill to Treat Primary Dysmenorrhea Phase 3
Completed NCT00104546 - Vitamin K Injections for the Treatment of Painful Menstruation Phase 1
Completed NCT06011928 - MOPEXE and RE in Treating Dysmenorrhea N/A
Not yet recruiting NCT06398990 - The Effect of Cognitive Exercise Therapy Approach and Yoga in Adolescents With Dysmenorrhoea N/A
Recruiting NCT02031523 - Multi-center Clinical Trials of Sanjie Analgesic Capsule in Treating Endometriosis Phase 4
Completed NCT01449305 - Effectiveness of Nanoone Woman Underwear Using in the Management of Dysmenorrhea N/A
Completed NCT02910167 - Observational Prospective Study to Evaluate AEs, Risk Factors and Drug Utilization of BUSCAPINA COMPOSITUM N in Adults From Metropolitan Lima
Not yet recruiting NCT05461846 - Effect of Integrated Neuromuscular Inhibition Technique in Females With Menstrual Low Back Pain N/A
Completed NCT05247333 - Implementation of a Minor Ailment Service in Community Pharmacy Practice N/A
Not yet recruiting NCT03697746 - Comparison of Dexketoprofen, Paracetamol and Ibuprofen in the Treatment of Primary Dysmenorrhea N/A
Recruiting NCT03394547 - Pulsed Electromagnetic Field Treatment for Painful Periods N/A
Recruiting NCT06294743 - Posterior Tibia Nerve Neuroprolotherapy for Dysmenorrhea Early Phase 1
Active, not recruiting NCT01738204 - The Women's Health Study: From Adolescence to Adulthood
Completed NCT01462370 - Study to Assess the Safety and Efficacy of Etoricoxib Versus Ibuprofen in the Treatment of Dysmenorrhea (MK-0663-145 AM1) Phase 3
Completed NCT01250587 - Dose-Finding Study of PDC31 in Patients With Primary Dysmenorrhea Phase 1
Completed NCT00951561 - A Comparison Study of Pain Relief From Dysmenorrhea Between the Vipon Tampon and Ibuprofen N/A
Completed NCT03972917 - Observation of Long-term Effects on Endometrium and Uterine Fibroids in Women With Ulipristal Acetate Therapy