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

This study has been completed.
Sponsor:
Information provided by:
Nobelpharma
ClinicalTrials.gov Identifier:
NCT00746096
First received: August 29, 2008
Last updated: May 21, 2010
Last verified: May 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 primary dysmenorrhea.


Condition Intervention Phase
Dysmenorrhea
 Drug: Norethindrone,Ethinyl Estrsdiol
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Phase3,Placebo Controlled,Randomized,Double-Blinded,NSAID-Add-on,Clinical Trial of Mono-Phase Low Dose Oral Contraceptive Pill for Treatment of Primary Dysmenorrhea.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Nobelpharma:

Primary Outcome Measures:
  • patient response to treatment for primary dysmenorrhea ,as evaluated by VRS [ Time Frame: 16weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • change in the VAS of primary dysmenorrhea [ Time Frame: 16weeks ] [ Designated as safety issue: No ]

Enrollment: 113
Study Start Date: September 2008
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IKH-01 Drug: Norethindrone,Ethinyl Estrsdiol
Norethindrone 1mg/Ethinyl Estrsdiol 0.035mg

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • primary dysmenorrhea

Exclusion Criteria:

  • severe hepatopathy
  • pregnant woman
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00746096

Sponsors and Collaborators
Nobelpharma
Investigators
Study Director: Naoki Terakawa, M.D.,Ph.D. Nissay Hospital,Osaka,Japan
  More Information

No publications provided by Nobelpharma

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: IKH-01-6, Nobelpharma
ClinicalTrials.gov Identifier: NCT00746096     History of Changes
Other Study ID Numbers: IKH-01-6
Study First Received: August 29, 2008
Last Updated: May 21, 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
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic

ClinicalTrials.gov processed this record on May 22, 2013