DysmenorrheaPhase 3NCT01129102

Efficacy and Safety Study of NPC-01 to Treat Dysmenorrhea

A Phase 3 study testing NPC-01 and IKH-01 in people with Dysmenorrhea, run by Nobelpharma.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to determine whether NPC-01 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-01 and IKH-01
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 215 participants
Where: No sites listed yet
Study dates: May 2010to Apr 2011
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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: Phase 3, Placebo Controlled, Randomized, Double-blinded, Nonsteroidal Antiinflammatory Drug add-on, Clinical Trial of NPC-01 for Treatment of Dysmenorrhea

The purpose of this study is to determine whether NPC-01 is effective in the treatment of dysmenorrhea.

Read the 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).

Conditions: Dysmenorrhea
Being tested: NPC-01, IKH-01, Placebo
Medical subject headings: Dysmenorrhea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NPC-01Drug
Norethisterone 1mg, Ethinyl estradiol 0.02mg
IKH-01Drug
Norethisterone 1mg, Ethinyl estradiol 0.035mg
PlaceboDrug
Placebo for NPC-01

Study groups in NCT01129102
Study group	Role	What they receive
NPC-01	Experimental	Norethisterone 1mg, Ethinyl estradiol 0.02mg Receives: Drug: NPC-01
IKH-01	Active comparator	Norethisterone 1mg, Ethinyl estradiol 0.035mg Receives: Drug: IKH-01
Placebo	Placebo comparator	Placebo for NPC-01 Receives: Drug: Placebo

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 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
Measured: 16weeks

Secondary outcomes (1)

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.
Measured: 16weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2010Apr 2011

First posted24 May 2010 (estimated)
Study startMay 2010
Primary completionApr 2011
Study completionApr 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
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: 215 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01129102
Sponsor's protocol ID: NPC-01-2
Status last verified: Feb 2025
First submitted: 21 May 2010
Last updated: 5 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

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.
PubMed 37523477
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.
PubMed 27717552

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Not yet recruiting
Radiofrequency and Pelvic Floor Exercise for Primary Dysmenorrhea
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PRECISION-E2: Teverelix in Women With Endometriosis - Pharmacodynamics, Safety and Precision Medicine Correlates
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Ultrasound-Guided Radiofrequency Ablation for Focal Adenomyosis
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Mindfulness-Based Education For Women With Polycystic Ovary Syndrome
Polycystic Ovary Syndrome (PCOS), Menstrual Symptoms
Not yet recruiting
The Effect of a Ginger Formula on Menstrual Health vs a Placebo
Painful Menstruation

All Dysmenorrhea trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 3, Placebo Controlled, Randomized, Double-blinded, Nonsteroidal Antiinflammatory Drug add-on, Clinical Trial of NPC-01 for Treatment of Dysmenorrhea
ClinicalTrials.gov ID: NCT01129102
Acronym / sponsor ID: NPC-01-2
Conditions: Dysmenorrhea
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 215 participants (actual)
Lead sponsor: NobelpharmaIndustry (pharma, biotech, devices)
Study start: May 2010
Primary completion: Apr 2011 (actual)
Study completion: Apr 2011 (actual)
First posted: 24 May 2010 (estimated)
Results: Posted 17 Jun 2014

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 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).

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-01	Experimental	Drug: NPC-01Norethisterone 1mg, Ethinyl estradiol 0.02mg
IKH-01	Active comparator	Drug: IKH-01Norethisterone 1mg, Ethinyl estradiol 0.035mg
Placebo	Placebo comparator	Drug: PlaceboPlacebo for NPC-01

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-01Norethisterone 1mg, Ethinyl estradiol 0.02mg	Drug	NPC-01
IKH-01Norethisterone 1mg, Ethinyl estradiol 0.035mg	Drug	IKH-01
PlaceboPlacebo for NPC-01	Drug	Placebo

Primary outcome

Patient Response to Treatment for 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

1 secondary outcome

Difference in the VAS of Primary Dysmenorrhea (Baseline/Pretreatment-End of Treatment)
Time frame: 16weeks

Results and safety

Results posted to the registry on 17 Jun 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
NPC-01	110	102
IKH-01	50	44
Placebo	55	48

Primary outcome: Patient Response to Treatment for Dysmenorrhea, as Evaluated by Difference of Total Dysmenorrhea Score (Baseline/Pretreatment-End of Treatment)

Time frame: 16weeks. Mean (Standard Deviation). Unit: units on a scale

Measure	NPC-01 n = 105	Placebo n = 54
Pretreatment	4.1 (1.00)	4.2 (0.95)
End of treatment	1.8 (1.57)	2.9 (1.55)

Population analysed: Primary endpoints were analysed based on FAS population. Data unavailable for IKH-01 group because IKH-01 group only assigned for secondary dysmenorrhea.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: From initiation of study drug to end of 6 cycle of menstrual, an average of 6 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
NPC-01	0 of 107 (0%)	103 of 107 (96.3%)	Not reported
IKH-01	1 of 47 (2.1%)	45 of 47 (95.7%)	Not reported
Placebo	0 of 54 (0%)	44 of 54 (81.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37523477Schroll 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.
Derived from this study: PubMed 27717552Harada 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.

Related trials for Dysmenorrhea

Not yet recruiting
Radiofrequency and Pelvic Floor Exercise for Primary Dysmenorrhea
Primary Dysmenorrhea
Not yet recruitingPhase 2
PRECISION-E2: Teverelix in Women With Endometriosis - Pharmacodynamics, Safety and Precision Medicine Correlates
Endometriosis Pelvic, Endometriosis Ovaries
Not yet recruiting
Ultrasound-Guided Radiofrequency Ablation for Focal Adenomyosis
Adenomyosis, Adenomyoma of Uterus
Active, not recruiting
Mindfulness-Based Education For Women With Polycystic Ovary Syndrome
Polycystic Ovary Syndrome (PCOS), Menstrual Symptoms
Not yet recruiting
The Effect of a Ginger Formula on Menstrual Health vs a Placebo
Painful Menstruation

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.

Naoki Terakawa, M.D.,Ph.D. study director

Nissay Hospital,Osaka,Japan

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing NPC-01 and IKH-01 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 5 Mar 2025. 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?

Yes. Results are posted in the registry (first posted 17 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Difference of Total Dysmenorrhea Score (Baseline/Pretreatment-End of Treatment) (time frame: 16weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01129102, which also lists 2 linked publications.

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 5 Mar 2025.