Back to resultsEfficacy and Safety Study of Low Dose Oral Contraceptive Pill to Treat Primary Dysmenorrhea
Primary Purpose
Dysmenorrhea
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
IKH-01
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Dysmenorrhea
Eligibility Criteria
Inclusion Criteria:
- primary dysmenorrhea
Exclusion Criteria:
- severe hepatopathy
- pregnant woman
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
IKH-01
Placebo
Arm Description
ethinyl estradiol 0.035mg and norethisterone 1mg
Placebo for ethinyl estradiol 0.035mg and norethisterone 1mg
Outcomes
Primary Outcome Measures
Patient Response to Treatment for Primary Dysmenorrhea, as Evaluated by Difference of Total Dysmenorrhea Score (Baseline/Pretreatment-End of Treatment)
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)
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00746096
Brief Title
Efficacy and Safety Study of Low Dose Oral Contraceptive Pill to Treat Primary Dysmenorrhea
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.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nobelpharma
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysmenorrhea
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
115 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IKH-01
Arm Type
Experimental
Arm Description
ethinyl estradiol 0.035mg and norethisterone 1mg
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo for ethinyl estradiol 0.035mg and norethisterone 1mg
Intervention Type
Drug
Intervention Name(s)
IKH-01
Intervention Description
ethinyl estradiol 0.035mg and norethisterone 1mg
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo for ethinyl estradiol 0.035mg and norethisterone 1mg
Primary Outcome Measure Information:
Title
Patient Response to Treatment for Primary Dysmenorrhea, as Evaluated by Difference of Total Dysmenorrhea Score (Baseline/Pretreatment-End of Treatment)
Description
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
Time Frame
16weeks
Secondary Outcome Measure Information:
Title
Difference in the VAS of Primary Dysmenorrhea (Baseline/Pretreatment-dnd of Treatment)
Description
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.
Time Frame
16weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
primary dysmenorrhea
Exclusion Criteria:
severe hepatopathy
pregnant woman
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Naoki Terakawa, M.D.,Ph.D.
Organizational Affiliation
Nissay Hospital,Osaka,Japan
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
21420678
Citation
Harada T, Momoeda M, Terakawa N, Taketani Y, Hoshiai H. Evaluation of a low-dose oral contraceptive pill for primary dysmenorrhea: a placebo-controlled, double-blind, randomized trial. Fertil Steril. 2011 May;95(6):1928-31. doi: 10.1016/j.fertnstert.2011.02.045. Epub 2011 Mar 21.
Results Reference
result
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Efficacy and Safety Study of Low Dose Oral Contraceptive Pill to Treat Primary Dysmenorrhea
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