Efficacy and Safety,Long-term 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: NCT00212277
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : September 10, 2010
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Brief Summary:
The purpose of this long-term study is to determine whether combination oral contraceptive pill of Norethindrone & Ethinyl estradiol is effective in the treatmentof dysmenorrhea associated with endometriosis.

Condition or disease Intervention/treatment Phase
Dysmenorrhea Drug: Norethindrone,Ethinyl Estradiol Phase 3

Study Type : Interventional  (Clinical Trial)
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase3,Open-label,Long-term,NSAID-Add-on,Clinical Trial of Mono-phase Low-dose Oral Contraceptive Pill for Treatment of Dysmenorrhea Associated With Endometriosis.
Study Start Date : February 2005
Primary Completion Date : September 2006
Study Completion Date : February 2007

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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): NCT00212277

Sponsors and Collaborators
Study Director: Naoki Terakawa, M.D.,Ph.D. Tottori University,Tottori,Japan Identifier: NCT00212277     History of Changes
Other Study ID Numbers: IKH-01-5
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: September 10, 2010
Last Verified: September 2010

Additional relevant MeSH terms:
Menstruation Disturbances
Pathologic Processes
Pelvic Pain
Neurologic Manifestations
Signs and Symptoms
Ethinyl Estradiol
Contraceptive Agents
Norethindrone acetate
Contraceptives, Oral
Contraceptives, Oral, Combined
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Reproductive Control Agents
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic