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The purpose of this study is to determine whether NPC-01 is effective in the treatment of dysmenorrhea.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NPC-01 | Experimental | Norethisterone 1mg, Ethinyl estradiol 0.02mg |
|
| IKH-01 | Active Comparator | Norethisterone 1mg, Ethinyl estradiol 0.035mg |
|
| Placebo | Placebo Comparator | Placebo for NPC-01 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NPC-01 | Drug | Norethisterone 1mg, Ethinyl estradiol 0.02mg |
| |
| IKH-01 |
| 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 | 16weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 16weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Naoki Terakawa, M.D.,Ph.D. | Nissay Hospital,Osaka,Japan | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37523477 | Derived | Schroll JB, Black AY, Farquhar C, Chen I. Combined oral contraceptive pill for primary dysmenorrhoea. Cochrane Database Syst Rev. 2023 Jul 31;7(7):CD002120. doi: 10.1002/14651858.CD002120.pub4. | |
| 27717552 | Derived | Harada T, Momoeda M. Evaluation of an ultra-low-dose oral contraceptive for dysmenorrhea: a placebo-controlled, double-blind, randomized trial. Fertil Steril. 2016 Dec;106(7):1807-1814. doi: 10.1016/j.fertnstert.2016.08.051. Epub 2016 Oct 4. |
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| ID | Title | Description |
|---|---|---|
| FG000 | NPC-01 | Norethisterone 1mg, Ethinyl estradiol 0.02mg NPC-01: Norethisterone 1mg, Ethinyl estradiol 0.02mg |
| FG001 | IKH-01 | Norethisterone 1mg, Ethinyl estradiol 0.035mg IKH-01: Norethisterone 1mg, Ethinyl estradiol 0.035mg |
| FG002 | Placebo | Placebo for NPC-01 Placebo: Placebo for NPC-01 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline analysis population was carried out based on FAS data set. 110, 50 and 55 pts were assigned to NPC-01, IKH-01 and placebo, respectively, and administered study drug 108, 47 and 54 pts. Safety and FAS analysis was carried out on 107, 47 and 54 pts/105, 47 and 54 pts due to 1 and 2 pts of NPC-01 have no available data respectively.
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| ID | Title | Description |
|---|---|---|
| BG000 | NPC-01 | Norethisterone 1mg, Ethinyl estradiol 0.02mg |
| BG001 | IKH-01 | Norethisterone 1mg, Ethinyl estradiol 0.035mg |
| 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 | Primary endpoints were analysed based on FAS population. Data unavailable for IKH-01 group because IKH-01 group only assigned for secondary dysmenorrhea. | Posted | Mean | Standard Deviation | units on a scale | 16weeks |
|
From initiation of study drug to end of 6 cycle of menstrual, an average of 6 months
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| 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 1mg, Ethinyl estradiol 0.02mg NPC-01: Norethisterone 1mg, Ethinyl estradiol 0.02mg |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain lower (Dysmenorrhoea aggravated) | Reproductive system and breast 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Department director of clinical development department 1 | Nobelpharma | +81-5651-1177 | murakami@nobelpharma.co.jp |
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| ID | Term |
|---|---|
| D004412 | Dysmenorrhea |
| ID | Term |
|---|---|
| D008599 | Menstruation Disturbances |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017699 | Pelvic Pain |
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| Drug |
Norethisterone 1mg, Ethinyl estradiol 0.035mg |
|
| Placebo | Drug | Placebo for NPC-01 |
|
| Protocol Violation |
|
| Pregnancy |
|
| Adverse Event |
|
| Lost to Follow-up |
|
| BG002 | Placebo | Placebo for NPC-01 |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Age, Customized | Number | participants |
|
| Sex/Gender, Customized | Number | participants |
|
| Diagnostic categories | Number | participants |
|
| Total dysmenorrhea score | 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 | Mean | Standard Deviation | units on a scale |
|
| Visual analogue scale (VAS) for primary dysmenorrhea | 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. | Mean | Standard Deviation | units on a scale |
|
Norethisterone 1mg, Ethinyl estradiol 0.02mg
NPC-01: Norethisterone 1mg, Ethinyl estradiol 0.02mg
| OG001 | Placebo | Placebo for NPC-01 Placebo: Placebo for NPC-01 |
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | 16weeks |
|
|
|
| 0 |
| 107 |
| 103 |
| 107 |
| EG001 | IKH-01 | Norethisterone 1mg, Ethinyl estradiol 0.035mg IKH-01: Norethisterone 1mg, Ethinyl estradiol 0.035mg | 1 | 47 | 45 | 47 |
| EG002 | Placebo | Placebo for NPC-01 Placebo: Placebo for NPC-01 | 0 | 54 | 44 | 54 |
| Abdominal pain | Gastrointestinal disorders | MedDRA-J 13.1 | Non-systematic Assessment |
|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA-J 13.1 | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA-J 13.1 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA-J 13.1 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal 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 |
|
| Nasopharyngitis | Infections and infestations | MedDRA-J 13.1 | Non-systematic Assessment |
|
| Vulvovaginal candidiasis | Infections and infestations | MedDRA-J 13.1 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA-J 13.1 | Non-systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA-J 13.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA-J 13.1 | Non-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 | Non-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 |
|
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 |