Pain Associated With Endometriosis - Full Text View

Purpose

This study will evaluate the efficacy and safety of an investigational medication compared with placebo in the treatment of pain associated with endometriosis.

Condition	Intervention	Phase
Endometriosis	Drug: Danazol Once Weekly Drug: Danazol Twice Weekly Drug: Placebo Once Weekly Drug: Placebo Twice Weekly	Phase 2

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

Resource links provided by NLM:

MedlinePlus related topics: Endometriosis

Drug Information available for: Danazol

U.S. FDA Resources

Further study details as provided by KV Pharmaceutical Company:

Primary Outcome Measures:

Pain associated with endometriosis [ Time Frame: 3 months of treatment ] [ Designated as safety issue: No ]

Enrollment:	66
Study Start Date:	February 2007
Study Completion Date:	January 2009
Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: Danazol Once Weekly semi-solid
Experimental: 2	Drug: Danazol Twice Weekly semi-solid
Placebo Comparator: 3	Drug: Placebo Once Weekly semi-solid
Placebo Comparator: 4	Drug: Placebo Twice Weekly semi-solid

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Menstruating female 18-50 years of age,
Regular cycle length of 21 to 35 days with menstrual bleeding that typically lasts no more than 7 days,
Has pain associated with endometriosis,
Has a documented history consistent with endometriosis,

Exclusion Criteria:

Is pregnant or lactating,
Has a history of or has active thrombosis

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00758953

Hide Study Locations

Locations

United States, Arizona

Chandler, Arizona, United States, 85225

Phoenix, Arizona, United States, 85015

Phoenix, Arizona, United States, 85032
United States, Arkansas

Little Rock, Arkansas, United States, 72205
United States, California

Carmichael, California, United States, 95608

San Diego, California, United States, 92123

San Diego, California, United States, 92121

San Diego, California, United States, 92130
United States, Colorado

Denver, Colorado, United States, 80206
United States, Connecticut

Britain, Connecticut, United States, 06050

West Hartford, Connecticut, United States, 06117
United States, Florida

Aventura, Florida, United States, 33180

Boynton Beach, Florida, United States, 33437

Clearwater, Florida, United States, 33759

Hudson, Florida, United States, 34667

Tampa, Florida, United States, 33607
United States, Georgia

Alpharetta, Georgia, United States, 30005

Atlanta, Georgia, United States, 30342

Decatur, Georgia, United States, 30034
United States, Idaho

Boise, Idaho, United States, 83712

Boise, Idaho, United States, 83702
United States, Illinois

Champaign, Illinois, United States, 61820
United States, Louisiana

Baton Rouge, Louisiana, United States, 70808
United States, Missouri

Chesterfield, Missouri, United States, 63017
United States, New Jersey

Moorestown, New Jersey, United States, 08057
United States, North Carolina

Winston-Salem, North Carolina, United States, 27103
United States, North Dakota

Bismarck, North Dakota, United States, 58501

Fargo, North Dakota, United States, 58104
United States, Ohio

Cleveland, Ohio, United States, 44122

Columbus, Ohio, United States, 43231
United States, Pennsylvania

Abington, Pennsylvania, United States, 19001

West Chester, Pennsylvania, United States, 19380
United States, Tennessee

Jackson, Tennessee, United States, 38305

Memphis, Tennessee, United States, 38119

Memphis, Tennessee, United States, 38120

Nashville, Tennessee, United States, 37203
United States, Texas

Irving, Texas, United States, 75061
United States, Utah

Salt Lake City, Utah, United States, 84107
Canada, British Columbia

Kelowna, British Columbia, Canada, V1Y 3G8

North Vancouver, British Columbia, Canada, V7M 2H5

Penicton, British Columbia, Canada, V2A 5G8
Canada, Ontario

Halifax, Ontario, Canada, B3K 5R5

Ottawa, Ontario, Canada, K1V 0Y3

Toronto, Ontario, Canada, M5H 3P5

Whitby, Ontario, Canada, L1N 4V6

Windsor, Ontario, Canada, N8N 4X9
Canada, Saskatchewan

Saskatoon, Saskatchewan, Canada, S7K 1N8
Russian Federation

Moscow, Russian Federation

St. Petersburg, Russian Federation

Sponsors and Collaborators

KV Pharmaceutical Company

Investigators

Study Director:

Jim Joffrion

KV Pharmaceutical Company

More Information

No publications provided

Responsible Party:	KV Pharmaceutical Company
ClinicalTrials.gov Identifier:	NCT00758953 History of Changes
Other Study ID Numbers:	DZ2-201-601-725036
Study First Received:	September 23, 2008
Last Updated:	March 2, 2012
Health Authority:	United States: Food and Drug Administration Canada: Health Canada Russia: Ministry of Health of the Russian Federation

Additional relevant MeSH terms:

Endometriosis
Genital Diseases, Female
Danazol
Estrogen Antagonists
Estrogen Receptor Modulators

Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013