DysmenorrheaPhase 3NCT02362711
Efficacy and Safety, Long-Term Study of NPC-16 to Treat Dysmenorrhea
A Phase 3 study testing NPC-16 Standard Dosing Regimen Group and NPC-16 Continuous Dosing Regimen Group in people with Dysmenorrhea, run by Nobelpharma.
Trial summary
The purpose of this long-term study is to determine whether NPC-16 is effective in the treatment of dysmenorrhea. Read more about this study
- Who is it for?
- Ages 16 years and older, women only
- Conditions the study is for
- Dysmenorrhea
- What is being tested?
- NPC-16 Standard Dosing Regimen Group and NPC-16 Continuous Dosing Regimen Group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 248 participants
- Where
- No sites listed yet
- Study dates
- Feb 2015to 28 Jan 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- dysmenorrhea
Who cannot join
- severe hepatopathy
- pregnant woman
About this study
Official title: Phase3, Placebo Controlled, Randomized, Double-blinded, Long-Term, NSAID-Add-on, Clinical Trial of NPC-16 for Treatment of Dysmenorrhea
The purpose of this long-term study is to determine whether NPC-16 is effective in the treatment of dysmenorrhea.
- Conditions
- Dysmenorrhea
- Being tested
- NPC-16 Standard Dosing Regimen Group, NPC-16 Continuous Dosing Regimen Group, Placebo Group
- Medical subject headings
- Dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NPC-16 Standard Dosing Regimen GroupDrug
Also called Levonorgestrel 0.09mg, Ethinylestradiol 0.02mg
NPC-16 Continuous Dosing Regimen GroupDrug
Also called Levonorgestrel 0.09mg, Ethinylestradiol 0.02mg
Placebo GroupDrug
Also called Placebo for NPC-16
| Study group | Role | What they receive |
|---|---|---|
| NPC-16 Standard Dosing Regimen Group | Experimental | Levonorgestrel 0.09mg, Ethinylestradiol 0.02mg Receives: Drug: NPC-16 Standard Dosing Regimen Group |
| NPC-16 Continuous Dosing Regimen Group | Experimental | Levonorgestrel 0.09mg, Ethinylestradiol 0.02mg Receives: Drug: NPC-16 Continuous Dosing Regimen Group |
| Placebo Group | Placebo comparator | Placebo for NPC-16 Receives: Drug: Placebo Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Response to Treatment for Dysmenorrhea, as Evaluated by Total Dysmenorrhea Score
Measured: 52 weeks
Secondary outcomes (1)
Patient Response to Treatment for Dysmenorrhea, as Evaluated by Visual Analogue Scale (VAS) of Dysmenorrhea
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completionJan 2017
- Study completion28 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysmenorrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 248 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nobelpharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tasuku Harada, MD, PhD, Study chair, Tottori UniversityMikio Momoeda, MD, PhD, Study chair, St. Luke's International Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02362711
- Sponsor's protocol ID
- NPC-16-2
- Status last verified
- Feb 2015
- First submitted
- 9 Feb 2015
- Last updated
- 16 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase3, Placebo Controlled, Randomized, Double-blinded, Long-Term, NSAID-Add-on, Clinical Trial of NPC-16 for Treatment of Dysmenorrhea
- ClinicalTrials.gov ID
- NCT02362711
- Acronym / sponsor ID
- NPC-16-2
- Conditions
- Dysmenorrhea
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 248 participants (actual)
- Lead sponsor
- NobelpharmaIndustry (pharma, biotech, devices)
- Study start
- Feb 2015 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- 28 Jan 2017 (actual)
- First posted
- 13 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this long-term study is to determine whether NPC-16 is effective in the treatment of dysmenorrhea.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NPC-16 Standard Dosing Regimen Group | Experimental | Drug: NPC-16 Standard Dosing Regimen GroupLevonorgestrel 0.09mg, Ethinylestradiol 0.02mg |
| NPC-16 Continuous Dosing Regimen Group | Experimental | Drug: NPC-16 Continuous Dosing Regimen GroupLevonorgestrel 0.09mg, Ethinylestradiol 0.02mg |
| Placebo Group | Placebo comparator | Drug: Placebo GroupPlacebo for NPC-16 |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- dysmenorrhea
Key exclusion criteria (2 listed)
- severe hepatopathy
- pregnant woman
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NPC-16 Standard Dosing Regimen GroupAlso: Levonorgestrel 0.09mg, Ethinylestradiol 0.02mg | Drug | NPC-16 Standard Dosing Regimen Group |
| NPC-16 Continuous Dosing Regimen GroupAlso: Levonorgestrel 0.09mg, Ethinylestradiol 0.02mg | Drug | NPC-16 Continuous Dosing Regimen Group |
| Placebo GroupAlso: Placebo for NPC-16 | Drug | Placebo Group |
Primary outcome
Patient Response to Treatment for Dysmenorrhea, as Evaluated by Total Dysmenorrhea Score
Time frame: 52 weeks
1 secondary outcome
Patient Response to Treatment for Dysmenorrhea, as Evaluated by Visual Analogue Scale (VAS) of Dysmenorrhea
Time frame: 52 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tasuku Harada, MD, PhD study chair
Tottori University
Mikio Momoeda, MD, PhD study chair
St. Luke's International Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing NPC-16 Standard Dosing Regimen Group and NPC-16 Continuous Dosing Regimen Group in people with Dysmenorrhea, run by Nobelpharma.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Response to Treatment for Dysmenorrhea, as Evaluated by Total Dysmenorrhea Score (time frame: 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2019.