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Efficacy and Safety,Long-term Study of Low-dose Oral Contraceptive Pill to Treat Dysmenorrhea.

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ClinicalTrials.gov Identifier: NCT00212277
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : September 10, 2010
Sponsor:
Information provided by:
Nobelpharma

Study Description
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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 Design
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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
Actual Primary Completion Date : September 2006
Actual Study Completion Date : February 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Period Pain

Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • dysmenorrhea associated with endometriosis

Exclusion Criteria:

  • severe hepatopathy
  • pregnant woman
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT00212277


Sponsors and Collaborators
Nobelpharma
Investigators
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Study Director: Naoki Terakawa, M.D.,Ph.D. Tottori University,Tottori,Japan
More Information
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ClinicalTrials.gov 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:
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Dysmenorrhea
Menstruation Disturbances
Pathologic Processes
Pelvic Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Contraceptive Agents
Norethindrone
Norethindrone Acetate
Contraceptives, Oral
 Contraceptives, Oral, Combined
Estradiol
Ethinyl Estradiol
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Reproductive Control Agents
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic