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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IKH-01 | Experimental | ethinyl estradiol 0.035mg and norethisterone 1mg |
|
| Placebo | Placebo Comparator | Placebo for ethinyl estradiol 0.035mg and norethisterone 1mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IKH-01 | Drug | ethinyl estradiol 0.035mg and norethisterone 1mg |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 16weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 |
|---|---|---|---|
| 21420678 | Result | Harada T, Momoeda M, Terakawa N, Taketani Y, Hoshiai H. Evaluation of a low-dose oral contraceptive pill for primary dysmenorrhea: a placebo-controlled, double-blind, randomized trial. Fertil Steril. 2011 May;95(6):1928-31. doi: 10.1016/j.fertnstert.2011.02.045. Epub 2011 Mar 21. |
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This study was conducted between September 2008 and August 2009, involving 115 patients with primary dysmenorrhea at 13 center of Japan.
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| ID | Title | Description |
|---|---|---|
| FG000 | IKH-01 | Patient received IKH-01 orally based on 28 days cycle that was consist of 21 days administration period and 7 days free of medication. The treatment was initiated on the third day of the menstrual cycle and continued to the fourth cycle. |
| FG001 | Placebo | Patient received placebo orally based on 28 days cycle that was consist of 21 days administration period and 7 days free of medication. The treatment was initiated on the third day of the menstrual cycle and continued to the fourth cycle. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
58 and 57 pts were assigned to IKH-01 or placebo group, and 57 and 56 pts started study drug adminitstration. Five pts in the IKH-01 group were excluded from FAS due to no available data of efficacy but include safety set and 1 pts placebo group was exculded from FAS and safety analysis population because of no visti after the drug administration.
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| ID | Title | Description |
|---|---|---|
| BG000 | IKH-01 | 0.035mg ethinyl estradiol and 1 mg norethisterone |
| BG001 | Placebo | Placebo for ethinyl estradiol 0.035mg and norethisterone 1mg |
| 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 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 | 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. | Posted | Mean | Standard Deviation | units on a scale | 16weeks |
|
From study administration to 6 cycles of menstruation, 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 | IKH-01 | 0.035mg ethinyl estradiol and 1 mg norethisterone |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA-J12.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Department director of clinical development department 1 | Nobelpharma | +81-3-5651-1177 | 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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| Placebo |
| Drug |
Placebo for ethinyl estradiol 0.035mg and norethisterone 1mg |
|
| Lost to Follow-up |
|
| Protocol Violation |
|
| No study drug treatment |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Number | participants |
|
| 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 |
|
| VAS | 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 |
|
0.035mg ethinyl estradiol and 1 mg norethisterone |
| OG001 | Placebo | Placebo for 0.035mg ethinyl estradiol and 1 mg norethisterone |
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | 16weeks |
|
|
|
| 0 |
| 57 |
| 52 |
| 57 |
| EG001 | Placebo | Placebo for 0.035mg ethinyl estradiol and 1 mg norethisterone | 0 | 55 | 40 | 55 |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA-J12.0 | Non-systematic Assessment |
|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA-J12.0 | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA-J12.0 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA-J12.0 | Non-systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA-J12.0 | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA-J12.0 | Non-systematic Assessment |
|
| Blood triglyceride increased | Investigations | MedDRA-J12.0 | Systematic Assessment |
|
| Protein urine prsent | Investigations | MedDRA-J12.0 | Systematic Assessment |
|
| Blood fibrinogen increased | Investigations | MedDRA-J12.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA-J12.0 | Non-systematic Assessment |
|
| Metrorrhagia | Reproductive system and breast disorders | MedDRA-J12.0 | Systematic Assessment |
|
| Oligomenorrhoea | Reproductive system and breast disorders | MedDRA-J12.0 | Systematic Assessment |
|
| Hypomenorrhoea | Reproductive system and breast disorders | MedDRA-J12.0 | Systematic Assessment |
|
| Menorrhagia | Reproductive system and breast disorders | MedDRA-J12.0 | Systematic Assessment |
|
| Polymenorrhoea | Reproductive system and breast disorders | MedDRA-J12.0 | 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 |