Dysmenorrhea
Conditions
Brief summary
The purpose of this study is to determine whether combination oral contraceptive pill of norethindrone and ethinyl estradiol is effective in the treatment of primary dysmenorrhea.
Interventions
DRUGIKH-01
ethinyl estradiol 0.035mg and norethisterone 1mg
DRUGPlacebo
Placebo for ethinyl estradiol 0.035mg and norethisterone 1mg
Sponsors
Nobelpharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* primary dysmenorrhea
Exclusion criteria
* severe hepatopathy * pregnant woman
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Response to Treatment for Primary 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-dnd 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
Recruitment details
This study was conducted between September 2008 and August 2009, involving 115 patients with primary dysmenorrhea at 13 center of Japan.
Participants by arm
| Arm | Count |
|---|---|
| IKH-01 0.035mg ethinyl estradiol and 1 mg norethisterone | 52 |
| Placebo Placebo for ethinyl estradiol 0.035mg and norethisterone 1mg | 55 |
| Total | 107 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Lost to Follow-up | 2 | 1 |
| Overall Study | No study drug treatment | 1 | 1 |
| Overall Study | Protocol Violation | 1 | 0 |
| Overall Study | Withdrawal by Subject | 5 | 1 |
Baseline characteristics
| Characteristic | IKH-01 | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 29.1 years STANDARD_DEVIATION 6.28 | 29.2 years STANDARD_DEVIATION 7.15 | 29.1 years STANDARD_DEVIATION 6.71 |
| Dysmenorrhea score | 3.8 units on a scale STANDARD_DEVIATION 0.94 | 3.6 units on a scale STANDARD_DEVIATION 0.71 | 3.7 units on a scale STANDARD_DEVIATION 0.83 |
| Sex/Gender, Customized Female | 52 participants | 55 participants | 107 participants |
| VAS | 57.2 units on a scale STANDARD_DEVIATION 18 | 60.0 units on a scale STANDARD_DEVIATION 16.82 | 58.6 units on a scale STANDARD_DEVIATION 17.32 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 52 / 57 | 40 / 55 |
| serious Total, serious adverse events | 0 / 57 | 0 / 55 |
Outcome results
Primary
Patient Response to Treatment for Primary 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: Five patients in the IKH-01 group were excluded from efficacy analysis due to no available data for 3 patients and 2-4 administration days for 2 patients.~One patient in the placebo group was also excluded from efficacy analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IKH-01 | Patient Response to Treatment for Primary Dysmenorrhea, as Evaluated by Difference of Total Dysmenorrhea Score (Baseline/Pretreatment-End of Treatment) | Baseline (0W) | 3.8 units on a scale | Standard Deviation 0.94 |
| IKH-01 | Patient Response to Treatment for Primary Dysmenorrhea, as Evaluated by Difference of Total Dysmenorrhea Score (Baseline/Pretreatment-End of Treatment) | End of Treatment (16W) | 1.2 units on a scale | Standard Deviation 1.26 |
| Placebo | Patient Response to Treatment for Primary Dysmenorrhea, as Evaluated by Difference of Total Dysmenorrhea Score (Baseline/Pretreatment-End of Treatment) | Baseline (0W) | 3.6 units on a scale | Standard Deviation 0.71 |
| Placebo | Patient Response to Treatment for Primary Dysmenorrhea, as Evaluated by Difference of Total Dysmenorrhea Score (Baseline/Pretreatment-End of Treatment) | End of Treatment (16W) | 2.2 units on a scale | Standard Deviation 1.43 |
Secondary
Difference in the VAS of Primary 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: 16weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IKH-01 | Difference in the VAS of Primary Dysmenorrhea (Baseline/Pretreatment-dnd of Treatment) | End of Treatment (16W) | 21.2 units on a scale | Standard Deviation 21.05 |
| IKH-01 | Difference in the VAS of Primary Dysmenorrhea (Baseline/Pretreatment-dnd of Treatment) | Baseline (0W) | 57.2 units on a scale | Standard Deviation 21.1 |
| Placebo | Difference in the VAS of Primary Dysmenorrhea (Baseline/Pretreatment-dnd of Treatment) | End of Treatment (16W) | 39.2 units on a scale | Standard Deviation 23.1 |
| Placebo | Difference in the VAS of Primary Dysmenorrhea (Baseline/Pretreatment-dnd of Treatment) | Baseline (0W) | 60.0 units on a scale | Standard Deviation 16.82 |