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Trial record 5 of 192 for:    dysmenorrhea

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00746096
First Posted: September 3, 2008
Last Update Posted: June 26, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Nobelpharma
  Purpose
The purpose of this study is to determine whether combination oral contraceptive pill of norethindrone and ethinyl estradiol is effective in the treatment of primary dysmenorrhea.

Condition Intervention Phase
Dysmenorrhea Drug: IKH-01 Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Phase 3, Placebo Controlled, Randomized, Double-blinded, Nonsteroidal Antiinflammatory Drug add-on Clinical Trial of Mono-phase Low Dose Oral Contraceptive Pill for Treatment of Primary Dysmenorrhea.

Resource links provided by NLM:


Further study details as provided by Nobelpharma:

Primary Outcome Measures:
  • Patient Response to Treatment for Primary Dysmenorrhea, as Evaluated by Difference of Total Dysmenorrhea Score (Baseline/Pretreatment-End of Treatment) [ Time Frame: 16weeks ]

    The detail of dysmenorrhea score that was used in this study is the following. These subscales summed for a total dysmenorrhea score (minimum 0 to maximum 6). Pain score None 0 : None Mild 1 : There are some troubles for work Moderate 2 : Needing to rest in bed and/or affecting work Severe 3 : Morre than 1 day in bed and not possible to work

    Drug score (during a menstrual period) None 0 : None Mild 1 : taking analgesics for 1 days Moderate 2 : taking analgesics for 2 days Severe 3 : taking analgesics more than 3 days



Secondary Outcome Measures:
  • Difference in the VAS of Primary Dysmenorrhea (Baseline/Pretreatment-dnd of Treatment) [ Time Frame: 16weeks ]
    VAS stands for Visual Analogue Scale of pain. The scale was rated as a graphic rating scale. as a 100mm baseline from 0:No pain to 100:Worst possible pain.


Enrollment: 115
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
ethinyl estradiol 0.035mg and norethisterone 1mg
Drug: IKH-01
ethinyl estradiol 0.035mg and norethisterone 1mg
Placebo Comparator: Placebo
Placebo for ethinyl estradiol 0.035mg and norethisterone 1mg
Drug: Placebo
Placebo for ethinyl estradiol 0.035mg and norethisterone 1mg

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • primary dysmenorrhea

Exclusion Criteria:

  • severe hepatopathy
  • pregnant woman
  Contacts and Locations
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): NCT00746096


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

Publications:
Responsible Party: Nobelpharma
ClinicalTrials.gov Identifier: NCT00746096     History of Changes
Other Study ID Numbers: IKH-01-6
First Submitted: August 29, 2008
First Posted: September 3, 2008
Results First Submitted: April 8, 2014
Results First Posted: June 13, 2014
Last Update Posted: June 26, 2014
Last Verified: June 2014

Additional relevant MeSH terms:
Dysmenorrhea
Menstruation Disturbances
Pathologic Processes
Pelvic Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Estradiol
Polyestradiol phosphate
Ethinyl Estradiol
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol valerate
Contraceptive Agents
Norethindrone
Norethindrone acetate
Contraceptives, Oral
Contraceptives, Oral, Combined
Anti-Inflammatory Agents, Non-Steroidal
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Reproductive Control Agents
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents