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Efficacy and Safety,Long-term Study of Low-dose Oral Contraceptive Pill to Treat Dysmenorrhea.
This study has been completed.
Sponsor:
Nobelpharma
Information provided by:
Nobelpharma
ClinicalTrials.gov Identifier:
NCT00212277
First received: September 13, 2005
Last updated: September 9, 2010
Last verified: September 2010
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Purpose
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 | Intervention | Phase |
|---|---|---|
| Dysmenorrhea | Drug: Norethindrone,Ethinyl Estradiol | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: 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. |
Resource links provided by NLM:
Further study details as provided by Nobelpharma:
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| 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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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00212277
Please refer to this study by its ClinicalTrials.gov identifier: NCT00212277
Sponsors and Collaborators
Nobelpharma
Investigators
| Study Director: | Naoki Terakawa, M.D.,Ph.D. | Tottori University,Tottori,Japan |
More Information
| ClinicalTrials.gov Identifier: | NCT00212277 History of Changes |
| Other Study ID Numbers: |
IKH-01-5 |
| Study First Received: | September 13, 2005 |
| Last Updated: | September 9, 2010 |
Additional relevant MeSH terms:
|
Dysmenorrhea Menstruation Disturbances Pathologic Processes Pelvic Pain Pain Neurologic Manifestations Signs and Symptoms Estradiol Ethinyl Estradiol Contraceptive Agents Norethindrone |
Norethindrone acetate Contraceptives, Oral Contraceptives, Oral, Combined Estrogens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Reproductive Control Agents Contraceptives, Oral, Synthetic Contraceptive Agents, Female |
ClinicalTrials.gov processed this record on June 27, 2017