Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this long-term study is to determine whether NPC-01 is effective in the treatment of dysmenorrhea associated with endometriosis.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NPC-01 | Experimental | Norethisterone, Ethinyl Estradiol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NPC-01 | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in the Visual Analog Scale (VAS) of Dysmenorrhea (Baseline/Pretreatment-dnd 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. | 52 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Naoki Terakawa, M.D.,Ph.D. | Nissay Hospital,Osaka,Japan | Study Director |
Not provided
Not provided
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | This analysis was carried out for 112 patients whom end of study data was available on FAS. | Posted | Mean | Standard Deviation | units on a scale | 52 weeks |
|
From study administration to 15 cycles of menstruation, an average of 14 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Depressed level of consciousness | Nervous system disorders | MedDRA-J 13.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA-J 13.1 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Department director of clinical development department 1 | Nobelpharma | +81-3-5651-1177 | murakami@nobelpharma.co.jp |
Not provided
| ID | Term |
|---|---|
| D004412 | Dysmenorrhea |
| ID | Term |
|---|---|
| D008599 | Menstruation Disturbances |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017699 | Pelvic Pain |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Lost to Follow-up |
|
| Physician Decision |
|
| years |
|
| Age, Customized | Number | participants |
|
| Sex/Gender, Customized | Number | participants |
|
| Total Dysmenorrhea Score (VRS; Verbal Rating Scale) | Mean | Standard Deviation | units on a scale |
|
| Visual Analogue Scale | Mean | Standard Deviation | units on a scale |
|
|
|
| Secondary | Difference in the Visual Analog Scale (VAS) of Dysmenorrhea (Baseline/Pretreatment-dnd 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. | This analysis was carried out for 112 patients whom end of study data was available on FAS. | Posted | Mean | Standard Deviation | units on a scale | 52 weeks |
|
|
|
| 5 |
| 147 |
| 147 |
| 147 |
| Endometriosis | Reproductive system and breast disorders | MedDRA-J 13.1 | Non-systematic Assessment |
|
| Cellulitis orbital | Infections and infestations | MedDRA-J 13.1 | Non-systematic Assessment |
|
| Haemorrhagic ovrian cyst | Vascular disorders | MedDRA-J 13.1 | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA-J 13.1 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA-J 13.1 | Non-systematic Assessment |
|
| Dental caries | Gastrointestinal disorders | MedDRA-J 13.1 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA-J 13.1 | Non-systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA-J 13.1 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA-J 13.1 | Non-systematic Assessment |
|
| Malaise | General disorders | MedDRA-J 13.1 | Non-systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA-J 13.1 | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA-J 13.1 | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA-J 13.1 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA-J 13.1 | Non-systematic Assessment |
|
| Blood triglycerides increased | Investigations | MedDRA-J 13.1 | Systematic Assessment |
|
| Weight increased | Investigations | MedDRA-J 13.1 | Systematic Assessment |
|
| Protein urine present | Investigations | MedDRA-J 13.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA-J 13.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA-J 13.1 | Non-systematic Assessment |
|
| Amenorrhoea | Reproductive system and breast disorders | MedDRA-J 13.1 | Systematic Assessment |
|
| Hypomenorrhoea | Reproductive system and breast disorders | MedDRA-J 13.1 | Systematic Assessment |
|
| Menorrhagia | Reproductive system and breast disorders | MedDRA-J 13.1 | Systematic Assessment |
|
| Metrorrhagia | Reproductive system and breast disorders | MedDRA-J 13.1 | Systematic Assessment |
|
| Oligomenorrhoea | Reproductive system and breast disorders | MedDRA-J 13.1 | Systematic Assessment |
|
| Polymenorrhoea | Reproductive system and breast disorders | MedDRA-J 13.1 | Systematic Assessment |
|
| Breast discomfort | Reproductive system and breast disorders | MedDRA-J 13.1 | Non-systematic Assessment |
|
| Haemorrhagic ovarian cyst | Reproductive system and breast disorders | MedDRA-J 13.1 | Systematic Assessment |
|
| Acnes | Skin and subcutaneous tissue disorders | MedDRA-J 13.1 | Non-systematic Assessment |
|
There is an agreement between the sponsor and PI that no restricts the PI's right but need to discuss the timing of publish date of trial results after the trial is completed.
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |