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

Overview

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.

Full Title of Study: “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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 2006

Interventions

  • Drug: Norethindrone,Ethinyl Estradiol

Participating in This Clinical Trial

Inclusion Criteria

  • dysmenorrhea associated with endometriosis Exclusion Criteria:

  • severe hepatopathy – pregnant woman

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Nobelpharma
  • Overall Official(s)
    • Naoki Terakawa, M.D.,Ph.D., Study Director, Tottori University,Tottori,Japan

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