Efficacy and Safety Study of NPC-01 to Treat Dysmenorrhea
Phase 3, Placebo Controlled, Randomized, Double-blinded, Nonsteroidal Antiinflammatory Drug add-on, Clinical Trial of NPC-01 for Treatment of Dysmenorrhea
1 other identifier
interventional
215
0 countries
N/A
Brief Summary
The purpose of this study is to determine whether NPC-01 is effective in the treatment of dysmenorrhea.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started May 2010
Shorter than P25 for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 21, 2010
CompletedFirst Posted
Study publicly available on registry
May 24, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedResults Posted
Study results publicly available
June 17, 2014
CompletedMarch 5, 2025
February 1, 2025
11 months
May 21, 2010
April 10, 2014
February 18, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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
16weeks
Secondary Outcomes (1)
Difference in the VAS of Primary Dysmenorrhea (Baseline/Pretreatment-End of Treatment)
16weeks
Study Arms (3)
NPC-01
EXPERIMENTALNorethisterone 1mg, Ethinyl estradiol 0.02mg
IKH-01
ACTIVE COMPARATORNorethisterone 1mg, Ethinyl estradiol 0.035mg
Placebo
PLACEBO COMPARATORPlacebo for NPC-01
Interventions
Eligibility Criteria
You may qualify if:
- dysmenorrhea
You may not qualify if:
- severe hepatopathy
- pregnant woman
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nobelpharmalead
Related Publications (2)
Schroll JB, Black AY, Farquhar C, Chen I. Combined oral contraceptive pill for primary dysmenorrhoea. Cochrane Database Syst Rev. 2023 Jul 31;7(7):CD002120. doi: 10.1002/14651858.CD002120.pub4.
PMID: 37523477DERIVEDHarada 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.
PMID: 27717552DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Department director of clinical development department 1
- Organization
- Nobelpharma
Study Officials
- STUDY DIRECTOR
Naoki Terakawa, M.D.,Ph.D.
Nissay Hospital,Osaka,Japan
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 21, 2010
First Posted
May 24, 2010
Study Start
May 1, 2010
Primary Completion
April 1, 2011
Study Completion
April 1, 2011
Last Updated
March 5, 2025
Results First Posted
June 17, 2014
Record last verified: 2025-02