Efficacy and Safety, Long-Term Study of NPC-16 to Treat D... | NCT02362711

Studies
Efficacy and Safety, Long-Term Study of NPC-16 to Treat Dysmenorrhea

NCT02362711

Sponsor

Nobelpharma

Status

Completed

Last Update Posted

Apr 16, 2019Actual

Enrollment

248Actual

Phase

Phase 3

Conditions

Dysmenorrhea

Interventions

NPC-16 Standard Dosing Regimen Group
NPC-16 Continuous Dosing Regimen Group
Placebo Group

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2015Actual

Primary Completion Date

Jan 2017Actual

Completion Date

Jan 28, 2017Actual

First Submitted Date

Feb 9, 2015

First Submission Date that Met QC Criteria

Feb 12, 2015

First Posted Date

Feb 13, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 14, 2019

Last Update Posted Date

Apr 16, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

248Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
NPC-16 Standard Dosing Regimen Group	Experimental	Levonorgestrel 0.09mg, Ethinylestradiol 0.02mg	Drug: NPC-16 Standard Dosing Regimen Group
NPC-16 Continuous Dosing Regimen Group	Experimental	Levonorgestrel 0.09mg, Ethinylestradiol 0.02mg	Drug: NPC-16 Continuous Dosing Regimen Group
Placebo Group	Placebo Comparator	Placebo for NPC-16	Drug: Placebo Group

Interventions

Name	Type	Description	Arm Group Labels	Other Names
NPC-16 Standard Dosing Regimen Group	Drug		NPC-16 Standard Dosing Regimen Group	Levonorgestrel 0.09mg, Ethinylestradiol 0.02mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Patient Response to Treatment for Dysmenorrhea, as Evaluated by Total Dysmenorrhea Score		52 weeks

Secondary Outcomes

Measure	Description	Time Frame
Patient Response to Treatment for Dysmenorrhea, as Evaluated by Visual Analogue Scale (VAS) of Dysmenorrhea		52 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

dysmenorrhea

Exclusion Criteria:

severe hepatopathy
pregnant woman

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tasuku Harada, MD, PhD	Tottori University	Study Chair
Mikio Momoeda, MD, PhD	St. Luke's International Hospital	Study Chair

Locations

Not provided

Type	Date	Date Unknown
Release	Sep 6, 2020
Reset	Sep 25, 2020
Release	Oct 15, 2020
Reset	Nov 5, 2020

Submission Tracking

Estimated Results First Submitted Date

Sep 6, 2020

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Sep 6, 2020			Sep 25, 2020
Oct 15, 2020

Condition Browse Module

MeSH Terms

ID	Term
D004412	Dysmenorrhea

Ancestor Terms

ID	Term
D008599	Menstruation Disturbances
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D017699	Pelvic Pain

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D016912	Levonorgestrel
D004997	Ethinyl Estradiol
C559142	NPC 16

Ancestor Terms

ID	Term
D009644	Norgestrel
D009652	Norpregnenes
D009650	Norpregnanes
D009654	Norsteroids
D013256

Browse Leaves

Not provided

Browse Branches

Not provided