Trial Outcomes & Findings for Efficacy and Safety Study of Low Dose Oral Contraceptive Pill to Treat Primary Dysmenorrhea (NCT NCT00746096)

Last Updated: 2025-03-06

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

115 participants

Primary outcome timeframe

16weeks

Results posted on

2025-03-06

Participant Flow

This study was conducted between September 2008 and August 2009, involving 115 patients with primary dysmenorrhea at 13 center of Japan.

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	58	57
Overall Study COMPLETED	48	54
Overall Study NOT COMPLETED	10	3

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.
Overall Study Adverse Event	1	0
Overall Study Withdrawal by Subject	5	1
Overall Study Lost to Follow-up	2	1
Overall Study Protocol Violation	1	0
Overall Study No study drug treatment	1	1

Baseline Characteristics

Efficacy and Safety Study of Low Dose Oral Contraceptive Pill to Treat Primary Dysmenorrhea

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	IKH-01 n=52 Participants 0.035mg ethinyl estradiol and 1 mg norethisterone	Placebo n=55 Participants Placebo for ethinyl estradiol 0.035mg and norethisterone 1mg	Total n=107 Participants Total of all reporting groups
Age, Continuous	29.1 years STANDARD_DEVIATION 6.28 • n=5 Participants	29.2 years STANDARD_DEVIATION 7.15 • n=7 Participants	29.1 years STANDARD_DEVIATION 6.71 • n=5 Participants
Sex/Gender, Customized Female	52 participants n=5 Participants	55 participants n=7 Participants	107 participants n=5 Participants
Dysmenorrhea score	3.8 units on a scale STANDARD_DEVIATION 0.94 • n=5 Participants	3.6 units on a scale STANDARD_DEVIATION 0.71 • n=7 Participants	3.7 units on a scale STANDARD_DEVIATION 0.83 • n=5 Participants
VAS	57.2 units on a scale STANDARD_DEVIATION 18.00 • n=5 Participants	60.0 units on a scale STANDARD_DEVIATION 16.82 • n=7 Participants	58.6 units on a scale STANDARD_DEVIATION 17.32 • n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	IKH-01 n=52 Participants 0.035mg ethinyl estradiol and 1 mg norethisterone	Placebo n=55 Participants Placebo for 0.035mg ethinyl estradiol and 1 mg norethisterone
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	2.2 units on a scale Standard Deviation 1.43
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	3.6 units on a scale Standard Deviation 0.71

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	IKH-01 n=52 Participants 0.035mg ethinyl estradiol and 1 mg norethisterone	Placebo n=55 Participants Placebo for 0.035mg ethinyl estradiol and 1 mg norethisterone
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	39.2 units on a scale Standard Deviation 23.10
Difference in the VAS of Primary Dysmenorrhea (Baseline/Pretreatment-dnd of Treatment) Baseline (0W)	57.2 units on a scale Standard Deviation 21.1	60.0 units on a scale Standard Deviation 16.82

Adverse Events

IKH-01

Serious events: 0 serious events

Other events: 52 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 40 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Department director of clinical development department 1

Nobelpharma

Phone: +81-3-5651-1177

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	IKH-01 n=57 participants at risk 0.035mg ethinyl estradiol and 1 mg norethisterone	Placebo n=55 participants at risk Placebo for 0.035mg ethinyl estradiol and 1 mg norethisterone
Gastrointestinal disorders Nausea	14.0% 8/57 • Number of events 9 • From study administration to 6 cycles of menstruation, an average of 6 months	1.8% 1/55 • Number of events 1 • From study administration to 6 cycles of menstruation, an average of 6 months
Gastrointestinal disorders Abdominal discomfort	7.0% 4/57 • Number of events 4 • From study administration to 6 cycles of menstruation, an average of 6 months	1.8% 1/55 • Number of events 1 • From study administration to 6 cycles of menstruation, an average of 6 months
Gastrointestinal disorders Abdominal pain lower	7.0% 4/57 • Number of events 6 • From study administration to 6 cycles of menstruation, an average of 6 months	1.8% 1/55 • Number of events 1 • From study administration to 6 cycles of menstruation, an average of 6 months
Gastrointestinal disorders Abdominal pain upper	7.0% 4/57 • Number of events 5 • From study administration to 6 cycles of menstruation, an average of 6 months	0.00% 0/55 • From study administration to 6 cycles of menstruation, an average of 6 months
Infections and infestations Nasopharyngitis	38.6% 22/57 • Number of events 40 • From study administration to 6 cycles of menstruation, an average of 6 months	27.3% 15/55 • Number of events 21 • From study administration to 6 cycles of menstruation, an average of 6 months
Infections and infestations Cystitis	5.3% 3/57 • Number of events 3 • From study administration to 6 cycles of menstruation, an average of 6 months	0.00% 0/55 • From study administration to 6 cycles of menstruation, an average of 6 months
Infections and infestations Influenza	5.3% 3/57 • Number of events 3 • From study administration to 6 cycles of menstruation, an average of 6 months	5.5% 3/55 • Number of events 3 • From study administration to 6 cycles of menstruation, an average of 6 months
Investigations Blood triglyceride increased	8.8% 5/57 • Number of events 6 • From study administration to 6 cycles of menstruation, an average of 6 months	3.6% 2/55 • Number of events 2 • From study administration to 6 cycles of menstruation, an average of 6 months
Investigations Protein urine prsent	7.0% 4/57 • Number of events 4 • From study administration to 6 cycles of menstruation, an average of 6 months	3.6% 2/55 • Number of events 2 • From study administration to 6 cycles of menstruation, an average of 6 months
Investigations Blood fibrinogen increased	5.3% 3/57 • Number of events 3 • From study administration to 6 cycles of menstruation, an average of 6 months	1.8% 1/55 • Number of events 1 • From study administration to 6 cycles of menstruation, an average of 6 months
Nervous system disorders Headache	5.3% 3/57 • Number of events 5 • From study administration to 6 cycles of menstruation, an average of 6 months	10.9% 6/55 • Number of events 8 • From study administration to 6 cycles of menstruation, an average of 6 months
Reproductive system and breast disorders Metrorrhagia	64.9% 37/57 • Number of events 66 • From study administration to 6 cycles of menstruation, an average of 6 months	14.5% 8/55 • Number of events 21 • From study administration to 6 cycles of menstruation, an average of 6 months
Reproductive system and breast disorders Oligomenorrhoea	14.0% 8/57 • Number of events 12 • From study administration to 6 cycles of menstruation, an average of 6 months	14.5% 8/55 • Number of events 11 • From study administration to 6 cycles of menstruation, an average of 6 months
Reproductive system and breast disorders Hypomenorrhoea	7.0% 4/57 • Number of events 4 • From study administration to 6 cycles of menstruation, an average of 6 months	0.00% 0/55 • From study administration to 6 cycles of menstruation, an average of 6 months
Reproductive system and breast disorders Menorrhagia	5.3% 3/57 • Number of events 5 • From study administration to 6 cycles of menstruation, an average of 6 months	3.6% 2/55 • Number of events 2 • From study administration to 6 cycles of menstruation, an average of 6 months
Reproductive system and breast disorders Polymenorrhoea	5.3% 3/57 • Number of events 4 • From study administration to 6 cycles of menstruation, an average of 6 months	1.8% 1/55 • Number of events 1 • From study administration to 6 cycles of menstruation, an average of 6 months