Title

Efficacy and Safety Study of Low Dose Oral Contraceptive Pill to Treat Primary Dysmenorrhea
Phase 3, Placebo Controlled, Randomized, Double-blinded, Nonsteroidal Antiinflammatory Drug add-on Clinical Trial of Mono-phase Low Dose Oral Contraceptive Pill for Treatment of Primary Dysmenorrhea.
  • Phase

    Phase 3
  • Study Type

    Interventional
  • Study Participants

    115
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.
Study Started
Sep 30
2008
Primary Completion
Sep 30
2009
Study Completion
Sep 30
2009
Results Posted
Jun 13
2014
Estimate
Last Update
Jun 26
2014
Estimate

Drug IKH-01

ethinyl estradiol 0.035mg and norethisterone 1mg

Drug Placebo

Placebo for ethinyl estradiol 0.035mg and norethisterone 1mg

IKH-01 Experimental

ethinyl estradiol 0.035mg and norethisterone 1mg

Placebo Placebo Comparator

Placebo for ethinyl estradiol 0.035mg and norethisterone 1mg

Criteria

Inclusion Criteria:

primary dysmenorrhea

Exclusion Criteria:

severe hepatopathy
pregnant woman

Summary

IKH-01

Placebo

All Events

Event Type Organ System Event Term IKH-01 Placebo

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

IKH-01

Baseline (0W)

3.8
units on a scale (Mean)
Standard Deviation: 0.94

End of Treatment (16W)

1.2
units on a scale (Mean)
Standard Deviation: 1.26

Placebo

Baseline (0W)

3.6
units on a scale (Mean)
Standard Deviation: 0.71

End of Treatment (16W)

2.2
units on a scale (Mean)
Standard Deviation: 1.43

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.

IKH-01

Baseline (0W)

57.2
units on a scale (Mean)
Standard Deviation: 21.1

End of Treatment (16W)

21.2
units on a scale (Mean)
Standard Deviation: 21.05

Placebo

Baseline (0W)

60.0
units on a scale (Mean)
Standard Deviation: 16.82

End of Treatment (16W)

39.2
units on a scale (Mean)
Standard Deviation: 23.10

Total

107
Participants

Age, Continuous

29.1
years (Mean)
Standard Deviation: 6.71

Dysmenorrhea score

3.7
units on a scale (Mean)
Standard Deviation: 0.83

VAS

58.6
units on a scale (Mean)
Standard Deviation: 17.32

Sex/Gender, Customized

Overall Study

IKH-01

Placebo

Drop/Withdrawal Reasons

IKH-01

Placebo