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

This study is ongoing, but not recruiting participants.

First Received: August 29, 2008 Last Updated: May 1, 2009 History of Changes

Sponsor:	Nobelpharma
Information provided by:	Nobelpharma
ClinicalTrials.gov Identifier:	NCT00746096

Purpose

The purpose of this study is to determine whether combination oral contraceptive pill of Norethindrone & Ethinyl estradiol is effective in the treatment of primary dysmenorrhea.

Condition	Intervention	Phase
Dysmenorrhea	Drug: Norethindrone,Ethinyl Estrsdiol	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Phase3,Placebo Controlled,Randomized,Double-Blinded,NSAID-Add-on,Clinical Trial of Mono-Phase Low Dose Oral Contraceptive Pill for Treatment of Primary Dysmenorrhea.

Resource links provided by NLM:

Drug Information available for: Norethindrone acetate Norethindrone

U.S. FDA Resources

Further study details as provided by Nobelpharma:

Primary Outcome Measures:

patient response to treatment for primary dysmenorrhea ,as evaluated by VRS [ Time Frame: 16weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

change in the VAS of primary dysmenorrhea [ Time Frame: 16weeks ] [ Designated as safety issue: No ]

Enrollment:	113
Study Start Date:	September 2008
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
IKH-01: Experimental	Drug: Norethindrone,Ethinyl Estrsdiol Norethindrone 1mg/Ethinyl Estrsdiol 0.035mg

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

primary dysmenorrhea

Exclusion Criteria:

severe hepatopathy
pregnant woman

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00746096

Sponsors and Collaborators

Nobelpharma

Investigators

Study Director:

Naoki Terakawa, M.D.,Ph.D.

Nissay Hospital,Osaka,Japan

More Information

No publications provided

Responsible Party:	Nobelpharma ( IKH-01-6 )
Study ID Numbers:	IKH-01-6
Study First Received:	August 29, 2008
Last Updated:	May 1, 2009
ClinicalTrials.gov Identifier:	NCT00746096 History of Changes
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:

Dysmenorrhea
Contraceptive Agents
Contraceptives, Oral
Physiological Effects of Drugs
Contraceptive Agents, Female
Pain
Reproductive Control Agents
Pharmacologic Actions

Signs and Symptoms
Pathologic Processes
Pelvic Pain
Menstruation Disturbances
Norethindrone
Therapeutic Uses
Contraceptives, Oral, Synthetic
Norethindrone acetate

ClinicalTrials.gov processed this record on November 20, 2009