Back to resultsEfficacy and Safety Study of NPC-01 to Treat Dysmenorrhea
Primary Purpose
Dysmenorrhea
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
NPC-01
IKH-01
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Dysmenorrhea
Eligibility Criteria
Inclusion Criteria:
- dysmenorrhea
Exclusion Criteria:
- severe hepatopathy
- pregnant woman
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
NPC-01
IKH-01
Placebo
Arm Description
Norethisterone 1mg, Ethinyl estradiol 0.02mg
Norethisterone 1mg, Ethinyl estradiol 0.035mg
Placebo for NPC-01
Outcomes
Primary Outcome Measures
Patient Response to Treatment for 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-End 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
NCT01129102
Brief Title
Efficacy and Safety Study of NPC-01 to Treat Dysmenorrhea
Official Title
Phase 3, Placebo Controlled, Randomized, Double-blinded, Nonsteroidal Antiinflammatory Drug add-on, Clinical Trial of NPC-01 for Treatment of Dysmenorrhea
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (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 NPC-01 is effective in the treatment of dysmenorrhea.
Detailed Description
The main objective of this study is to confirm the effectiveness and safety profile of NPC-01 in comparison with placebo in the treatment of dysmenorrhea (primary and secondary dysmenorrhea).
Additionally we also investigate the differences of effectiveness of NPC-01 in comparison with IKH-01 in the treatment of secondary dysmenorrhea as a reference, because IKH-01 is already marketed at them.
To achieve these, closed testing procedure is used in this study. After confirming statistical differences between NPC-01 and Placebo in the total dysmenorrhea, stratified analysis is carried out for primary dysmenorrhea (NPC-01, Placebo), and secondary dysmenorrhea (NPC-01, IKH-01 and Placebo).
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
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
215 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NPC-01
Arm Type
Experimental
Arm Description
Norethisterone 1mg, Ethinyl estradiol 0.02mg
Arm Title
IKH-01
Arm Type
Active Comparator
Arm Description
Norethisterone 1mg, Ethinyl estradiol 0.035mg
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo for NPC-01
Intervention Type
Drug
Intervention Name(s)
NPC-01
Intervention Description
Norethisterone 1mg, Ethinyl estradiol 0.02mg
Intervention Type
Drug
Intervention Name(s)
IKH-01
Intervention Description
Norethisterone 1mg, Ethinyl estradiol 0.035mg
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo for NPC-01
Primary Outcome Measure Information:
Title
Patient Response to Treatment for 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-End 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:
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
27717552
Citation
Harada T, Momoeda M. Evaluation of an ultra-low-dose oral contraceptive for dysmenorrhea: a placebo-controlled, double-blind, randomized trial. Fertil Steril. 2016 Dec;106(7):1807-1814. doi: 10.1016/j.fertnstert.2016.08.051. Epub 2016 Oct 4.
Results Reference
derived
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Efficacy and Safety Study of NPC-01 to Treat Dysmenorrhea
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