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Efficacy and Safety Study of Low Dose Oral Contraceptive Pill to Treat Dysmenorrhea

This study has been completed.
Sponsor:
Information provided by:
Nobelpharma
ClinicalTrials.gov Identifier:
NCT00212342
First received: September 13, 2005
Last updated: September 6, 2010
Last verified: September 2010
History of Changes
  Purpose

The purpose of this study is to determine whether combination oral contraceptive pill of Norethindrone & Ethinyl estradiol is effective in the treatment of dysmenorrhea associated with endometriosis.


Condition Intervention Phase
Dysmenorrhea
 Drug: Norethisterone,Ethinylestradiol
Drug: Sugar pill
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 3,Placebo Controlled,Randomized,Double-Blinded,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:

MedlinePlus related topics: Endometriosis
U.S. FDA Resources

Further study details as provided by Nobelpharma:

Primary Outcome Measures:
  • patient response to treatment for dysmenorrhea associated with endometriosis,as evaluated by VRS

Secondary Outcome Measures:
  • changes in the VAS of dysmenorrhea.
  • changes in the VRS of non-menstrual pain.
  • changes in the VAS of non-menstrual pain.
  • changes in the clinical evaluation of pelvic induration.
  • changes in the size of ovarian endometrioma.

Enrollment: 100
Study Start Date: December 2004
Study Completion Date: March 2006
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Norethisterone,Ethinylestradiol Drug: Norethisterone,Ethinylestradiol
Placebo Comparator: Sugar pill Drug: Sugar pill

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • dysmenorrhea associated with endometriosis

Exclusion Criteria:

  • severe hepatopathy
  • pregnant woman
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00212342

Sponsors and Collaborators
Nobelpharma
Investigators
Study Director: Naoki Terakawa, M.D.,Ph.D. Tottori University,Tottori,Japan
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00212342     History of Changes
Other Study ID Numbers: IKH-01-4
Study First Received: September 13, 2005
Last Updated: September 6, 2010
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

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

ClinicalTrials.gov processed this record on May 16, 2013