Efficacy and Safety, Long-Term Study of NPC-01 to Treat Dysmenorrhea Associated With Endometriosis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nobelpharma
ClinicalTrials.gov Identifier:
NCT00902746
First received: May 7, 2009
Last updated: May 15, 2014
Last verified: May 2014
Results First Received: April 10, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Dysmenorrhea
Intervention: Drug: NPC-01

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations

Total 168 patients were consented and registered at minus 2 cycles of study drug administration as provisional registration.

After provisional registration, investigators confirmed their eligibility of patients by test gynecological examination, transvaginal ultrasound etc.) and 149 patients were formally registered for this study.


Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
NPC-01

Norethisterone, Ethinyl Estradiol

NPC-01: This study consist of the following steps.

Step 1(Norethisterone 0.6mg, Ethinyl Estradiol 0.035mg):From first study medication to 3th menstrual cycles.

Step 2(Norethisterone 1mg, Ethinyl Estradiol 0.035mg):

After interim analysis of the results of step 1, in the case of the efficacy results meet prespecified criterion, same dose level will be continued to 13th menstrual cycles including step 1. If the results do not meet prespecified criterion, the dose will be increased to Norethisterone 1mg, Ethinyl Estradiol 0.035mg and be continued newly until 13th menstrual cycle from this point.


Participant Flow:   Overall Study
    NPC-01  
STARTED     149  
Initiation of Study Drug Administration     148  
Transfer to Step 2     133  
COMPLETED     113  
NOT COMPLETED     36  
Protocol Violation                 7  
Withdrawal by Subject                 16  
Adverse Event                 8  
Lost to Follow-up                 3  
Physician Decision                 2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Baseline analysis were carried out on 147 patients except 1 patients who has no available data of efficacy and safety in 148 cases that study drug administration was started.

Reporting Groups
  Description
NPC-01

Norethisterone, Ethinyl Estradiol

NPC-01: This study consist of the following steps.

Step 1(Norethisterone 0.6mg, Ethinyl Estradiol 0.035mg):From first study medication to 3th menstrual cycles.

Step 2(Norethisterone 0.6mg, Ethinyl Estradiol 0.035mg, or Norethisterone 1mg, Ethinyl Estradiol 0.035mg):

After interim analysis of the results of step 1, in the case of the efficacy results meet prespecified criterion, same dose level will be continued to 13th menstrual cycles including step 1. If the results do not meet prespecified criterion, the dose will be increased to Norethisterone 1mg, Ethinyl Estradiol 0.035mg and be continued newly until 13th menstrual cycle from this point.


Baseline Measures
    NPC-01  
Number of Participants  
[units: participants]
  147  
Age  
[units: years]
Mean ± Standard Deviation
  33.2  ± 7.12  
Age, Customized  
[units: participants]
 
Under 30 years of age     51  
30 year of age and older     96  
Gender, Customized  
[units: participants]
 
Female     147  
Total Dysmenorrhea Score (VRS; Verbal Rating Scale)  
[units: units on a scale]
Mean ± Standard Deviation
  4.1  ± 0.99  
Visual Analogue Scale  
[units: units on a scale]
Mean ± Standard Deviation
  53.1  ± 21.49  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Patient Response to Treatment for Dysmenorrhea, as Evaluated by Difference of Total Dysmenorrhea Score (Baseline/Pretreatment-End of Treatment)   [ Time Frame: 52 weeks ]

2.  Secondary:   Difference in the Visual Analog Scale (VAS) of Dysmenorrhea (Baseline/Pretreatment-dnd of Treatment)   [ Time Frame: 52 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Department director of clinical development department 1
Organization: Nobelpharma
phone: +81-3-5651-1177
e-mail: murakami@nobelpharma.co.jp


No publications provided


Responsible Party: Nobelpharma
ClinicalTrials.gov Identifier: NCT00902746     History of Changes
Other Study ID Numbers: NPC-01-1
Study First Received: May 7, 2009
Results First Received: April 10, 2014
Last Updated: May 15, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency