Dysmenorrhea
Conditions
Brief summary
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). 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).
Interventions
Sponsors
Nobelpharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* dysmenorrhea
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) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference in the VAS of Primary Dysmenorrhea (Baseline/Pretreatment-End of Treatment) | 16weeks | 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
Participants by arm
| Arm | Count |
|---|---|
| NPC-01 Norethisterone 1mg, Ethinyl estradiol 0.02mg | 105 |
| IKH-01 Norethisterone 1mg, Ethinyl estradiol 0.035mg | 47 |
| Placebo Placebo for NPC-01 | 54 |
| Total | 206 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 2 | 2 | 1 |
| Overall Study | Lost to Follow-up | 2 | 0 | 0 |
| Overall Study | No study drug treatment | 2 | 3 | 1 |
| Overall Study | Pregnancy | 0 | 0 | 1 |
| Overall Study | Protocol Violation | 0 | 1 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 0 | 3 |
Baseline characteristics
| Characteristic | NPC-01 | IKH-01 | Placebo | Total |
|---|---|---|---|---|
| Age, Continuous | 32.4 years STANDARD_DEVIATION 7.29 | 34.0 years STANDARD_DEVIATION 6.93 | 30.4 years STANDARD_DEVIATION 7.41 | 32.3 years STANDARD_DEVIATION 7.21 |
| Age, Customized 30 year of age and older | 66 participants | 34 participants | 25 participants | 125 participants |
| Age, Customized Under 30 years of age | 39 participants | 13 participants | 29 participants | 81 participants |
| Diagnostic categories Primary dysmenorrhea | 55 participants | 0 participants | 28 participants | 83 participants |
| Diagnostic categories Secondary dysmenorrhea | 50 participants | 47 participants | 26 participants | 123 participants |
| Sex/Gender, Customized Female | 105 participants | 47 participants | 54 participants | 206 participants |
| Total dysmenorrhea score Primary dysmenorrhea | 3.9 units on a scale STANDARD_DEVIATION 0.92 | NA units on a scale | 4.3 units on a scale STANDARD_DEVIATION 0.9 | NA units on a scale |
| Total dysmenorrhea score Secondary dysmenorrhea | 4.3 units on a scale STANDARD_DEVIATION 1.05 | 4.0 units on a scale STANDARD_DEVIATION 0.87 | 4.1 units on a scale STANDARD_DEVIATION 0.99 | 4.1 units on a scale STANDARD_DEVIATION 0.96 |
| Total dysmenorrhea score Total dysmenorrhea | 4.1 units on a scale STANDARD_DEVIATION 1 | NA units on a scale | 4.2 units on a scale STANDARD_DEVIATION 0.95 | NA units on a scale |
| Visual analogue scale (VAS) for primary dysmenorrhea | 51.8 units on a scale STANDARD_DEVIATION 20.57 | NA units on a scale | 48.6 units on a scale STANDARD_DEVIATION 20.15 | NA units on a scale |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 103 / 107 | 45 / 47 | 44 / 54 |
| serious Total, serious adverse events | 0 / 107 | 1 / 47 | 0 / 54 |
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: 16weeks
Population: Primary endpoints were analysed based on FAS population. Data unavailable for IKH-01 group because IKH-01 group only assigned for secondary dysmenorrhea.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NPC-01 | Patient Response to Treatment for Dysmenorrhea, as Evaluated by Difference of Total Dysmenorrhea Score (Baseline/Pretreatment-End of Treatment) | Pretreatment | 4.1 units on a scale | Standard Deviation 1 |
| NPC-01 | Patient Response to Treatment for Dysmenorrhea, as Evaluated by Difference of Total Dysmenorrhea Score (Baseline/Pretreatment-End of Treatment) | End of treatment | 1.8 units on a scale | Standard Deviation 1.57 |
| Placebo | Patient Response to Treatment for Dysmenorrhea, as Evaluated by Difference of Total Dysmenorrhea Score (Baseline/Pretreatment-End of Treatment) | Pretreatment | 4.2 units on a scale | Standard Deviation 0.95 |
| Placebo | Patient Response to Treatment for Dysmenorrhea, as Evaluated by Difference of Total Dysmenorrhea Score (Baseline/Pretreatment-End of Treatment) | End of treatment | 2.9 units on a scale | Standard Deviation 1.55 |
Secondary
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.
Time frame: 16weeks
Population: This analysis was carried out based on FAS population. IKH-01 was not allocated for primary dysmenorrhea in this study. Therefore, VAS for primary dysmenorrhea is not available in IKH-01 group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NPC-01 | Difference in the VAS of Primary Dysmenorrhea (Baseline/Pretreatment-End of Treatment) | Pretreatment | 51.8 units on a scale | Standard Deviation 20.57 |
| NPC-01 | Difference in the VAS of Primary Dysmenorrhea (Baseline/Pretreatment-End of Treatment) | End of treatment | 21.2 units on a scale | Standard Deviation 20.18 |
| Placebo | Difference in the VAS of Primary Dysmenorrhea (Baseline/Pretreatment-End of Treatment) | Pretreatment | 48.6 units on a scale | Standard Deviation 20.15 |
| Placebo | Difference in the VAS of Primary Dysmenorrhea (Baseline/Pretreatment-End of Treatment) | End of treatment | 35.6 units on a scale | Standard Deviation 21.74 |