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The purpose of this study is to compare the serum levels of estradiol, progesterone, FSH and LH in NPC-01 or IKH-01 one treatment cycle with those in before and after administration cycle.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NPC-01 | Experimental | 1mg norethisterone and 0.02mg ethinyl estradiol |
|
| IKH-01 | Active Comparator | 1mg norethisterone and 0.35mg ethinyl estradiol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NPC-01 | Drug | NPC-01 contains 1mg norethisterone and 0.02mg ethinyl estradiol |
|
| Measure | Description | Time Frame |
|---|---|---|
| Comparing Estradiol AUC of Menstrual Period During Study Drug Administration With Pre and Post Study Drug Administration (Baseline(BL)-Study Drug Administration(SDA), Follow up(FU)-Study Drug Administration(ADA)) | Estradiol was measured on day 3, 6, 9, 12, 15, 18, 21, 24 on 3 consecutive menstrual period (pre administration/Baseline(BL), study drug administration(SDA), post administration/follow up(FU)) and calculated AUC from these data | Day 3, 6, 9, 12, 15, 18, 21, 24 of menstrual cycles |
| Comparing Progesterone AUC of Menstrual Period During Study Drug Administration With Pre and Post Study Drug Administration (Baseline(BL)-Study Drug Administration(SDA), Follow up(FU)-Study Drug Administration(ADA)) | Progesterone was measured on day 3, 6, 9, 12, 15, 18, 21, 24 on 3 consecutive menstrual period (pre administration/Baseline(BL), study drug administration(SDA), post administration/follow up(FU)) and calculated AUC from these data | Day 3, 6, 9, 12, 15, 18, 21, 24 of menstrual cycles |
| Measure | Description | Time Frame |
|---|---|---|
| Comparing FSH AUC of Menstrual Period During Study Drug Administration With Pre and Post Study Drug Administration (Baseline(BL)-Study Drug Administration(SDA), Follow up(FU)-Study Drug Administration(ADA)) | FSH was measured on day 3, 6, 9, 12, 15, 18, 21, 24 on 3 consecutive menstrual period (pre administration/Baseline(BL), study drug administration(SDA), post administration/follow up(FU)) and calculated AUC from these data |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Takefumi Matuo, MD | Hyogo Prefectural AWAJI Hospital | Principal Investigator |
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Fifty one subjects were screened for this study after acquiring an informed consent.
18 subjects of those participated in pre-medication menstrual cycle phase to confirm baseline of estradiol, progesterone, FSH and LH.
4 subjects withdrew IC during this phase, therefore, 14 subjects were registered and allocated study drugs.
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| ID | Title | Description |
|---|---|---|
| FG000 | NPC-01 | 1mg norethisterone and 0.02mg ethinyl estradiol NPC-01: NPC-01 contains 1mg norethisterone and 0.02mg ethinyl estradiol |
| FG001 | IKH-01 | 1mg norethisterone and 0.35mg ethinyl estradiol IKH-01: IKH-01 contains 1mg norethisterone and 0.35mg ethinyl estradiol |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All subjects were included for safety and pharmacodynamics analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | NPC-01 | 1mg norethisterone and 0.02mg ethinyl estradiol NPC-01: NPC-01 contains 1mg norethisterone and 0.02mg ethinyl estradiol |
| BG001 | IKH-01 | 1mg norethisterone and 0.35mg ethinyl estradiol IKH-01: IKH-01 contains 1mg norethisterone and 0.35mg ethinyl estradiol |
| 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 | Comparing Estradiol AUC of Menstrual Period During Study Drug Administration With Pre and Post Study Drug Administration (Baseline(BL)-Study Drug Administration(SDA), Follow up(FU)-Study Drug Administration(ADA)) | Estradiol was measured on day 3, 6, 9, 12, 15, 18, 21, 24 on 3 consecutive menstrual period (pre administration/Baseline(BL), study drug administration(SDA), post administration/follow up(FU)) and calculated AUC from these data | Posted | Mean | Standard Deviation | pg･day/mL, | Day 3, 6, 9, 12, 15, 18, 21, 24 of menstrual cycles |
|
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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 | 1mg norethisterone and 0.02mg ethinyl estradiol NPC-01: NPC-01 contains 1mg norethisterone and 0.02mg ethinyl estradiol |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA-J 13.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Department director of clinical development department 1 | Nobelpharama | +81-23-5651-1177 | murakami@nobelpharma.co.jp |
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| ID | Term |
|---|---|
| D009640 | Norethindrone |
| D004997 | Ethinyl Estradiol |
| ID | Term |
|---|---|
| D009652 | Norpregnenes |
| D009650 | Norpregnanes |
| D009654 | Norsteroids |
| D013256 | Steroids |
| D000072473 |
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| IKH-01 | Drug | IKH-01 contains 1mg norethisterone and 0.35mg ethinyl estradiol |
|
|
| Day 3, 6, 9, 12, 15, 18, 21, 24 of menstrual cycles |
| Comparing LH AUC of Menstrual Period During Study Drug Administration With Pre and Post Study Drug Administration (Baseline(BL)-Study Drug Administration(SDA), Follow up(FU)-Study Drug Administration(ADA)) | LH was measured on day 3, 6, 9, 12, 15, 18, 21, 24 on 3 consecutive menstrual period (pre administration/Baseline(BL), study drug administration(SDA), post administration/follow up(FU)) and calculated AUC from these data | Day 3, 6, 9, 12, 15, 18, 21, 24 of menstrual cycles |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Number | participants |
|
| Body weight | Mean | Standard Deviation | kg |
|
1mg norethisterone and 0.35mg ethinyl estradiol
IKH-01: IKH-01 contains 1mg norethisterone and 0.35mg ethinyl estradiol
|
|
| Secondary | Comparing FSH AUC of Menstrual Period During Study Drug Administration With Pre and Post Study Drug Administration (Baseline(BL)-Study Drug Administration(SDA), Follow up(FU)-Study Drug Administration(ADA)) | FSH was measured on day 3, 6, 9, 12, 15, 18, 21, 24 on 3 consecutive menstrual period (pre administration/Baseline(BL), study drug administration(SDA), post administration/follow up(FU)) and calculated AUC from these data | Posted | Mean | Standard Deviation | mIU･day/mL | Day 3, 6, 9, 12, 15, 18, 21, 24 of menstrual cycles |
|
|
|
| Primary | Comparing Progesterone AUC of Menstrual Period During Study Drug Administration With Pre and Post Study Drug Administration (Baseline(BL)-Study Drug Administration(SDA), Follow up(FU)-Study Drug Administration(ADA)) | Progesterone was measured on day 3, 6, 9, 12, 15, 18, 21, 24 on 3 consecutive menstrual period (pre administration/Baseline(BL), study drug administration(SDA), post administration/follow up(FU)) and calculated AUC from these data | Posted | Mean | Standard Deviation | ng･day/mL | Day 3, 6, 9, 12, 15, 18, 21, 24 of menstrual cycles |
|
|
|
| Secondary | Comparing LH AUC of Menstrual Period During Study Drug Administration With Pre and Post Study Drug Administration (Baseline(BL)-Study Drug Administration(SDA), Follow up(FU)-Study Drug Administration(ADA)) | LH was measured on day 3, 6, 9, 12, 15, 18, 21, 24 on 3 consecutive menstrual period (pre administration/Baseline(BL), study drug administration(SDA), post administration/follow up(FU)) and calculated AUC from these data | Posted | Mean | Standard Deviation | mIU･day/mL | Day 3, 6, 9, 12, 15, 18, 21, 24 of menstrual cycles |
|
|
|
| 0 |
| 7 |
| 6 |
| 7 |
| EG001 | IKH-01 | 1mg norethisterone and 0.35mg ethinyl estradiol IKH-01: IKH-01 contains 1mg norethisterone and 0.35mg ethinyl estradiol | 0 | 7 | 6 | 7 |
| Pharyngitis | Infections and infestations | MedDRA-J 13.1 | Non-systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA-J 13.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA-J 13.1 | Non-systematic Assessment |
|
| Tension headache | Nervous system disorders | MedDRA-J 13.1 | Non-systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA-J 13.1 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA-J 13.1 | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA-J 13.1 | Non-systematic Assessment |
|
| Aphthous stomatitis | Gastrointestinal disorders | MedDRA-J 13.1 | Non-systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA-J 13.1 | Non-systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA-J 13.1 | Non-systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA-J 13.1 | Non-systematic Assessment |
|
| Menorrhagia | Reproductive system and breast disorders | MedDRA-J 13.1 | Non-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 | Non-systematic Assessment |
|
| Feeling hot | General disorders | MedDRA-J 13.1 | Non-systematic Assessment |
|
| Electrocardiogram QT prolonged | Investigations | MedDRA-J 13.1 | Systematic Assessment |
|
| Plasminogen increased | Investigations | MedDRA-J 13.1 | 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.
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D009651 | Norpregnatrienes |
| D042782 | Estrogenic Steroids, Alkylated |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |