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

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ClinicalTrials.gov Identifier: NCT00212342
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : September 8, 2010
Sponsor:
Information provided by:
Nobelpharma

Brief Summary:
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 or disease Intervention/treatment Phase
Dysmenorrhea Drug: Norethisterone,Ethinylestradiol Drug: Sugar pill Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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.
Study Start Date : December 2004
Actual Primary Completion Date : January 2006
Actual Study Completion Date : March 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Norethisterone,Ethinylestradiol Drug: Norethisterone,Ethinylestradiol
Placebo Comparator: Sugar pill Drug: Sugar pill



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

Secondary Outcome Measures :
  1. changes in the VAS of dysmenorrhea.
  2. changes in the VRS of non-menstrual pain.
  3. changes in the VAS of non-menstrual pain.
  4. changes in the clinical evaluation of pelvic induration.
  5. changes in the size of ovarian endometrioma.


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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

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): NCT00212342


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

ClinicalTrials.gov Identifier: NCT00212342     History of Changes
Other Study ID Numbers: IKH-01-4
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: September 8, 2010
Last Verified: September 2010

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