Trial Outcomes & Findings for Efficacy and Safety Study of NPC-01 to Treat Dysmenorrhea (NCT NCT01129102)

Last Updated: 2025-03-05

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

215 participants

Primary outcome timeframe

16weeks

Results posted on

2025-03-05

Participant Flow

Participant milestones

Participant milestones
Measure	NPC-01 Norethisterone 1mg, Ethinyl estradiol 0.02mg NPC-01: Norethisterone 1mg, Ethinyl estradiol 0.02mg	IKH-01 Norethisterone 1mg, Ethinyl estradiol 0.035mg IKH-01: Norethisterone 1mg, Ethinyl estradiol 0.035mg	Placebo Placebo for NPC-01 Placebo: Placebo for NPC-01
Overall Study STARTED	110	50	55
Overall Study COMPLETED	102	44	48
Overall Study NOT COMPLETED	8	6	7

Reasons for withdrawal

Reasons for withdrawal
Measure	NPC-01 Norethisterone 1mg, Ethinyl estradiol 0.02mg NPC-01: Norethisterone 1mg, Ethinyl estradiol 0.02mg	IKH-01 Norethisterone 1mg, Ethinyl estradiol 0.035mg IKH-01: Norethisterone 1mg, Ethinyl estradiol 0.035mg	Placebo Placebo for NPC-01 Placebo: Placebo for NPC-01
Overall Study No study drug treatment	2	3	1
Overall Study Withdrawal by Subject	2	0	3
Overall Study Protocol Violation	0	1	1
Overall Study Pregnancy	0	0	1
Overall Study Adverse Event	2	2	1
Overall Study Lost to Follow-up	2	0	0

Baseline Characteristics

Efficacy and Safety Study of NPC-01 to Treat Dysmenorrhea

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	NPC-01 n=105 Participants Norethisterone 1mg, Ethinyl estradiol 0.02mg	IKH-01 n=47 Participants Norethisterone 1mg, Ethinyl estradiol 0.035mg	Placebo n=54 Participants Placebo for NPC-01	Total n=206 Participants Total of all reporting groups
Age, Continuous	32.4 years STANDARD_DEVIATION 7.29 • n=5 Participants	34.0 years STANDARD_DEVIATION 6.93 • n=7 Participants	30.4 years STANDARD_DEVIATION 7.41 • n=5 Participants	32.3 years STANDARD_DEVIATION 7.21 • n=4 Participants
Age, Customized Under 30 years of age	39 participants n=5 Participants	13 participants n=7 Participants	29 participants n=5 Participants	81 participants n=4 Participants
Age, Customized 30 year of age and older	66 participants n=5 Participants	34 participants n=7 Participants	25 participants n=5 Participants	125 participants n=4 Participants
Sex/Gender, Customized Female	105 participants n=5 Participants	47 participants n=7 Participants	54 participants n=5 Participants	206 participants n=4 Participants
Diagnostic categories Primary dysmenorrhea	55 participants n=5 Participants	0 participants n=7 Participants	28 participants n=5 Participants	83 participants n=4 Participants
Diagnostic categories Secondary dysmenorrhea	50 participants n=5 Participants	47 participants n=7 Participants	26 participants n=5 Participants	123 participants n=4 Participants
Total dysmenorrhea score Total dysmenorrhea	4.1 units on a scale STANDARD_DEVIATION 1.00 • n=5 Participants	NA units on a scale STANDARD_DEVIATION NA • n=7 Participants	4.2 units on a scale STANDARD_DEVIATION 0.95 • n=5 Participants	NA units on a scale STANDARD_DEVIATION NA • n=4 Participants
Total dysmenorrhea score Primary dysmenorrhea	3.9 units on a scale STANDARD_DEVIATION 0.92 • n=5 Participants	NA units on a scale STANDARD_DEVIATION NA • n=7 Participants	4.3 units on a scale STANDARD_DEVIATION 0.90 • n=5 Participants	NA units on a scale STANDARD_DEVIATION NA • n=4 Participants
Total dysmenorrhea score Secondary dysmenorrhea	4.3 units on a scale STANDARD_DEVIATION 1.05 • n=5 Participants	4.0 units on a scale STANDARD_DEVIATION 0.87 • n=7 Participants	4.1 units on a scale STANDARD_DEVIATION 0.99 • n=5 Participants	4.1 units on a scale STANDARD_DEVIATION 0.96 • n=4 Participants
Visual analogue scale (VAS) for primary dysmenorrhea	51.8 units on a scale STANDARD_DEVIATION 20.57 • n=5 Participants	NA units on a scale STANDARD_DEVIATION NA • n=7 Participants	48.6 units on a scale STANDARD_DEVIATION 20.15 • n=5 Participants	NA units on a scale STANDARD_DEVIATION NA • n=4 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	NPC-01 n=105 Participants Norethisterone 1mg, Ethinyl estradiol 0.02mg NPC-01: Norethisterone 1mg, Ethinyl estradiol 0.02mg	Placebo n=54 Participants Placebo for NPC-01 Placebo: Placebo for 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 1.00	4.2 units on a scale Standard Deviation 0.95
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	2.9 units on a scale Standard Deviation 1.55

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	NPC-01 n=105 Participants Norethisterone 1mg, Ethinyl estradiol 0.02mg NPC-01: Norethisterone 1mg, Ethinyl estradiol 0.02mg	Placebo n=54 Participants Placebo for NPC-01 Placebo: Placebo for 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	48.6 units on a scale Standard Deviation 20.15
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	35.6 units on a scale Standard Deviation 21.74

Adverse Events

NPC-01

Serious events: 0 serious events

Other events: 103 other events

Deaths: 0 deaths

IKH-01

Serious events: 1 serious events

Other events: 45 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 44 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	NPC-01 n=107 participants at risk Norethisterone 1mg, Ethinyl estradiol 0.02mg NPC-01: Norethisterone 1mg, Ethinyl estradiol 0.02mg	IKH-01 n=47 participants at risk Norethisterone 1mg, Ethinyl estradiol 0.035mg IKH-01: Norethisterone 1mg, Ethinyl estradiol 0.035mg	Placebo n=54 participants at risk Placebo for NPC-01 Placebo: Placebo for NPC-01
Reproductive system and breast disorders Abdominal pain lower (Dysmenorrhoea aggravated)	0.00% 0/107 • From initiation of study drug to end of 6 cycle of menstrual, an average of 6 months	2.1% 1/47 • Number of events 1 • From initiation of study drug to end of 6 cycle of menstrual, an average of 6 months	0.00% 0/54 • From initiation of study drug to end of 6 cycle of menstrual, an average of 6 months

Other adverse events

Additional Information

Department director of clinical development department 1

Nobelpharma

Phone: +81-5651-1177

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER

Measure	NPC-01 n=107 participants at risk Norethisterone 1mg, Ethinyl estradiol 0.02mg NPC-01: Norethisterone 1mg, Ethinyl estradiol 0.02mg	IKH-01 n=47 participants at risk Norethisterone 1mg, Ethinyl estradiol 0.035mg IKH-01: Norethisterone 1mg, Ethinyl estradiol 0.035mg	Placebo n=54 participants at risk Placebo for NPC-01 Placebo: Placebo for NPC-01
Gastrointestinal disorders Abdominal discomfort	0.00% 0/107 • From initiation of study drug to end of 6 cycle of menstrual, an average of 6 months	2.1% 1/47 • Number of events 2 • From initiation of study drug to end of 6 cycle of menstrual, an average of 6 months	5.6% 3/54 • Number of events 4 • From initiation of study drug to end of 6 cycle of menstrual, an average of 6 months
Gastrointestinal disorders Abdominal pain	5.6% 6/107 • Number of events 9 • From initiation of study drug to end of 6 cycle of menstrual, an average of 6 months	2.1% 1/47 • Number of events 1 • From initiation of study drug to end of 6 cycle of menstrual, an average of 6 months	1.9% 1/54 • Number of events 1 • From initiation of study drug to end of 6 cycle of menstrual, an average of 6 months
Gastrointestinal disorders Abdominal pain lower	11.2% 12/107 • Number of events 19 • From initiation of study drug to end of 6 cycle of menstrual, an average of 6 months	4.3% 2/47 • Number of events 3 • From initiation of study drug to end of 6 cycle of menstrual, an average of 6 months	1.9% 1/54 • Number of events 3 • From initiation of study drug to end of 6 cycle of menstrual, an average of 6 months
Gastrointestinal disorders Abdominal pain upper	4.7% 5/107 • Number of events 5 • From initiation of study drug to end of 6 cycle of menstrual, an average of 6 months	6.4% 3/47 • Number of events 4 • From initiation of study drug to end of 6 cycle of menstrual, an average of 6 months	7.4% 4/54 • Number of events 4 • From initiation of study drug to end of 6 cycle of menstrual, an average of 6 months
Gastrointestinal disorders Nausea	12.1% 13/107 • Number of events 17 • From initiation of study drug to end of 6 cycle of menstrual, an average of 6 months	21.3% 10/47 • Number of events 12 • From initiation of study drug to end of 6 cycle of menstrual, an average of 6 months	5.6% 3/54 • Number of events 5 • From initiation of study drug to end of 6 cycle of menstrual, an average of 6 months
Gastrointestinal disorders Vomiting	2.8% 3/107 • Number of events 3 • From initiation of study drug to end of 6 cycle of menstrual, an average of 6 months	6.4% 3/47 • Number of events 3 • From initiation of study drug to end of 6 cycle of menstrual, an average of 6 months	0.00% 0/54 • From initiation of study drug to end of 6 cycle of menstrual, an average of 6 months
Infections and infestations Cystitis	0.00% 0/107 • From initiation of study drug to end of 6 cycle of menstrual, an average of 6 months	6.4% 3/47 • Number of events 3 • From initiation of study drug to end of 6 cycle of menstrual, an average of 6 months	3.7% 2/54 • Number of events 3 • From initiation of study drug to end of 6 cycle of menstrual, an average of 6 months
Infections and infestations Gastroenteritis	4.7% 5/107 • Number of events 5 • From initiation of study drug to end of 6 cycle of menstrual, an average of 6 months	4.3% 2/47 • Number of events 2 • From initiation of study drug to end of 6 cycle of menstrual, an average of 6 months	5.6% 3/54 • Number of events 3 • From initiation of study drug to end of 6 cycle of menstrual, an average of 6 months
Infections and infestations Nasopharyngitis	39.3% 42/107 • Number of events 71 • From initiation of study drug to end of 6 cycle of menstrual, an average of 6 months	25.5% 12/47 • Number of events 16 • From initiation of study drug to end of 6 cycle of menstrual, an average of 6 months	35.2% 19/54 • Number of events 31 • From initiation of study drug to end of 6 cycle of menstrual, an average of 6 months
Infections and infestations Vulvovaginal candidiasis	0.00% 0/107 • From initiation of study drug to end of 6 cycle of menstrual, an average of 6 months	2.1% 1/47 • Number of events 1 • From initiation of study drug to end of 6 cycle of menstrual, an average of 6 months	5.6% 3/54 • Number of events 3 • From initiation of study drug to end of 6 cycle of menstrual, an average of 6 months
Musculoskeletal and connective tissue disorders Back pain	0.93% 1/107 • Number of events 1 • From initiation of study drug to end of 6 cycle of menstrual, an average of 6 months	4.3% 2/47 • Number of events 2 • From initiation of study drug to end of 6 cycle of menstrual, an average of 6 months	5.6% 3/54 • Number of events 3 • From initiation of study drug to end of 6 cycle of menstrual, an average of 6 months
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.00% 0/107 • From initiation of study drug to end of 6 cycle of menstrual, an average of 6 months	6.4% 3/47 • Number of events 3 • From initiation of study drug to end of 6 cycle of menstrual, an average of 6 months	0.00% 0/54 • From initiation of study drug to end of 6 cycle of menstrual, an average of 6 months
Nervous system disorders Headache	23.4% 25/107 • Number of events 41 • From initiation of study drug to end of 6 cycle of menstrual, an average of 6 months	21.3% 10/47 • Number of events 17 • From initiation of study drug to end of 6 cycle of menstrual, an average of 6 months	7.4% 4/54 • Number of events 6 • From initiation of study drug to end of 6 cycle of menstrual, an average of 6 months
Reproductive system and breast disorders Hypomenorrhoea	6.5% 7/107 • Number of events 7 • From initiation of study drug to end of 6 cycle of menstrual, an average of 6 months	2.1% 1/47 • Number of events 1 • From initiation of study drug to end of 6 cycle of menstrual, an average of 6 months	0.00% 0/54 • From initiation of study drug to end of 6 cycle of menstrual, an average of 6 months
Reproductive system and breast disorders Menorrhagia	5.6% 6/107 • Number of events 7 • From initiation of study drug to end of 6 cycle of menstrual, an average of 6 months	10.6% 5/47 • Number of events 5 • From initiation of study drug to end of 6 cycle of menstrual, an average of 6 months	0.00% 0/54 • From initiation of study drug to end of 6 cycle of menstrual, an average of 6 months
Reproductive system and breast disorders Metrorrhagia	70.1% 75/107 • Number of events 165 • From initiation of study drug to end of 6 cycle of menstrual, an average of 6 months	78.7% 37/47 • Number of events 71 • From initiation of study drug to end of 6 cycle of menstrual, an average of 6 months	38.9% 21/54 • Number of events 35 • From initiation of study drug to end of 6 cycle of menstrual, an average of 6 months
Reproductive system and breast disorders Oligomenorrhoea	28.0% 30/107 • Number of events 38 • From initiation of study drug to end of 6 cycle of menstrual, an average of 6 months	14.9% 7/47 • Number of events 9 • From initiation of study drug to end of 6 cycle of menstrual, an average of 6 months	16.7% 9/54 • Number of events 10 • From initiation of study drug to end of 6 cycle of menstrual, an average of 6 months
Reproductive system and breast disorders Polymenorrhoea	8.4% 9/107 • Number of events 12 • From initiation of study drug to end of 6 cycle of menstrual, an average of 6 months	10.6% 5/47 • Number of events 5 • From initiation of study drug to end of 6 cycle of menstrual, an average of 6 months	0.00% 0/54 • From initiation of study drug to end of 6 cycle of menstrual, an average of 6 months
Reproductive system and breast disorders Breast discomfort	7.5% 8/107 • Number of events 10 • From initiation of study drug to end of 6 cycle of menstrual, an average of 6 months	4.3% 2/47 • Number of events 2 • From initiation of study drug to end of 6 cycle of menstrual, an average of 6 months	0.00% 0/54 • From initiation of study drug to end of 6 cycle of menstrual, an average of 6 months