Dysmenorrhea
Conditions
Brief summary
The purpose of this long-term study is to determine whether NPC-01 is effective in the treatment of dysmenorrhea associated with endometriosis.
Interventions
DRUGNPC-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.
Sponsors
Nobelpharma
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Dysmenorrhea associated with endometriosis
Exclusion criteria
* Severe hepatopathy * Pregnant woman
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Response to Treatment for Dysmenorrhea, as Evaluated by Difference of Total Dysmenorrhea Score (Baseline/Pretreatment-End of Treatment) | 52 weeks | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference in the Visual Analog Scale (VAS) of Dysmenorrhea (Baseline/Pretreatment-dnd of Treatment) | 52 weeks | 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. |
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 147 |
| Total | 147 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 8 |
| Overall Study | Lost to Follow-up | 3 |
| Overall Study | Physician Decision | 2 |
| Overall Study | Protocol Violation | 7 |
| Overall Study | Withdrawal by Subject | 16 |
Baseline characteristics
| Characteristic | NPC-01 |
|---|---|
| Age, Continuous | 33.2 years STANDARD_DEVIATION 7.12 |
| Age, Customized 30 year of age and older | 96 participants |
| Age, Customized Under 30 years of age | 51 participants |
| Sex/Gender, Customized Female | 147 participants |
| Total Dysmenorrhea Score (VRS; Verbal Rating Scale) | 4.1 units on a scale STANDARD_DEVIATION 0.99 |
| Visual Analogue Scale | 53.1 units on a scale STANDARD_DEVIATION 21.49 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 147 / 147 |
| serious Total, serious adverse events | 5 / 147 |
Outcome results
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
Time frame: 52 weeks
Population: This analysis was carried out for 112 patients whom end of study data was available on FAS.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NPC-01 | Patient Response to Treatment for Dysmenorrhea, as Evaluated by Difference of Total Dysmenorrhea Score (Baseline/Pretreatment-End of Treatment) | 2.4 units on a scale | Standard Deviation 1.8 |
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.
Time frame: 52 weeks
Population: This analysis was carried out for 112 patients whom end of study data was available on FAS.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NPC-01 | Difference in the Visual Analog Scale (VAS) of Dysmenorrhea (Baseline/Pretreatment-dnd of Treatment) | 28.4 units on a scale | Standard Deviation 25.13 |