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Efficacy and Safety Study of Low Dose Oral Contraceptive Pill to Treat Dysmenorrhea

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: NCT00212342
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : September 8, 2010
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Brief Summary:
The purpose of this study is to determine whether combination oral contraceptive pill of Norethindrone & Ethinyl estradiol is effective in the treatment of dysmenorrhea associated with endometriosis.

Condition or disease Intervention/treatment Phase
Dysmenorrhea Drug: Norethisterone,Ethinylestradiol Drug: Sugar pill Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 3,Placebo Controlled,Randomized,Double-Blinded,NSAID-Add-on,Clinical Trial of Mono-phase Low Dose Oral Contraceptive Pill for Treatment of Dysmenorrhea Associated With Endometriosis.
Study Start Date : December 2004
Actual Primary Completion Date : January 2006
Actual Study Completion Date : March 2006

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Norethisterone,Ethinylestradiol Drug: Norethisterone,Ethinylestradiol
Placebo Comparator: Sugar pill Drug: Sugar pill

Primary Outcome Measures :
  1. patient response to treatment for dysmenorrhea associated with endometriosis,as evaluated by VRS

Secondary Outcome Measures :
  1. changes in the VAS of dysmenorrhea.
  2. changes in the VRS of non-menstrual pain.
  3. changes in the VAS of non-menstrual pain.
  4. changes in the clinical evaluation of pelvic induration.
  5. changes in the size of ovarian endometrioma.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • dysmenorrhea associated with endometriosis

Exclusion Criteria:

  • severe hepatopathy
  • pregnant woman

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): NCT00212342

Sponsors and Collaborators
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Study Director: Naoki Terakawa, M.D.,Ph.D. Tottori University,Tottori,Japan
Layout table for additonal information Identifier: NCT00212342    
Other Study ID Numbers: IKH-01-4
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: September 8, 2010
Last Verified: September 2010
Additional relevant MeSH terms:
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Menstruation Disturbances
Pathologic Processes
Pelvic Pain
Neurologic Manifestations
Ethinyl Estradiol
Norethindrone Acetate
Contraceptives, Oral, Hormonal
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Hormonal
Hormones, Hormone Substitutes, and Hormone Antagonists
Contraceptives, Oral, Synthetic