Efficacy and Safety,Long-term Study of Low-dose Oral Contraceptive Pill to Treat Dysmenorrhea.

This study has been completed.

Sponsor:

Information provided by:

Nobelpharma

ClinicalTrials.gov Identifier:

NCT00212277

First received: September 13, 2005

Last updated: September 9, 2010

Last verified: September 2010

History of Changes

Purpose

The purpose of this long-term study is to determine whether combination oral contraceptive pill of Norethindrone & Ethinyl estradiol is effective in the treatmentof dysmenorrhea associated with endometriosis.

Condition	Intervention	Phase
Dysmenorrhea	Drug: Norethindrone,Ethinyl Estradiol	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Phase3,Open-label,Long-term,NSAID-Add-on,Clinical Trial of Mono-phase Low-dose Oral Contraceptive Pill for Treatment of Dysmenorrhea Associated With Endometriosis.

Resource links provided by NLM:

MedlinePlus related topics: Endometriosis

Drug Information available for: Estradiol Norethindrone acetate Ethinylestradiol Norethindrone

U.S. FDA Resources

Further study details as provided by Nobelpharma:


Study Start Date:	February 2005
Study Completion Date:	February 2007
Primary Completion Date:	September 2006 (Final data collection date for primary outcome measure)

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

dysmenorrhea associated with endometriosis

Exclusion Criteria:

severe hepatopathy
pregnant woman

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00212277

Sponsors and Collaborators

Nobelpharma

Investigators


Study Director:	Naoki Terakawa, M.D.,Ph.D.	Tottori University,Tottori,Japan

More Information


ClinicalTrials.gov Identifier:	NCT00212277 History of Changes
Other Study ID Numbers:	IKH-01-5
Study First Received:	September 13, 2005
Last Updated:	September 9, 2010
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:


Dysmenorrhea Menstruation Disturbances Pathologic Processes Pelvic Pain Pain Neurologic Manifestations Signs and Symptoms Estradiol Ethinyl Estradiol Contraceptive Agents Norethindrone	Norethindrone acetate Contraceptives, Oral Contraceptives, Oral, Combined Estrogens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Reproductive Control Agents Contraceptive Agents, Female Contraceptives, Oral, Synthetic

ClinicalTrials.gov processed this record on September 28, 2016

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