Efficacy and Safety,Long-term Study of Low-dose Oral Contraceptive Pill to Treat Dysmenorrhea.
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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. |
ClinicalTrials.gov Identifier: NCT00212277 |
Recruitment Status :
Completed
First Posted : September 21, 2005
Last Update Posted : September 10, 2010
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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 |
Actual Primary Completion Date : | September 2006 |
Actual Study Completion Date : | February 2007 |

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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

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
Study Director: | Naoki Terakawa, M.D.,Ph.D. | Tottori University,Tottori,Japan |
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 |
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 |