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

Dysmenorrhea Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00746096
• Other study ID #: IKH-01-6
• Status: Completed
• Phase: Phase 3
• First received: August 29, 2008
• Last updated: June 12, 2014
• Start date: September 2008
• Est. completion date: September 2009

Study information

• Verified date: June 2014
• Source: Nobelpharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• primary dysmenorrhea

Exclusion Criteria:

• severe hepatopathy

• pregnant woman

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dysmenorrhea

Intervention

Drug:
• IKH-01
ethinyl estradiol 0.035mg and norethisterone 1mg
• Placebo
Placebo for ethinyl estradiol 0.035mg and norethisterone 1mg

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nobelpharma

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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	16weeks	No
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.	16weeks	No