NCT00758953

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2007

Geographic Reach
3 countries

49 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

September 23, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 25, 2008

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

March 6, 2012

Status Verified

March 1, 2012

Enrollment Period

1.9 years

First QC Date

September 23, 2008

Last Update Submit

March 2, 2012

Conditions

Endometriosis

Outcome Measures

Primary Outcomes (1)

  • Pain associated with endometriosis

    3 months of treatment

Study Arms (4)

1

EXPERIMENTAL
Drug: Danazol Once Weekly

2

EXPERIMENTAL
Drug: Danazol Twice Weekly

3

PLACEBO COMPARATOR
Drug: Placebo Once Weekly

4

PLACEBO COMPARATOR
Drug: Placebo Twice Weekly

Interventions

Danazol Once WeeklyDRUG

semi-solid

1
Danazol Twice WeeklyDRUG

semi-solid

2
Placebo Once WeeklyDRUG

semi-solid

3
Placebo Twice WeeklyDRUG

semi-solid

4

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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,

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (49)

Unknown Facility

Chandler, Arizona, 85225, United States

Location

Unknown Facility

Phoenix, Arizona, 85015, United States

Location

Unknown Facility

Phoenix, Arizona, 85032, United States

Location

Unknown Facility

Little Rock, Arkansas, 72205, United States

Location

Unknown Facility

Carmichael, California, 95608, United States

Location

Unknown Facility

San Diego, California, 92121, United States

Location

Unknown Facility

San Diego, California, 92123, United States

Location

Unknown Facility

San Diego, California, 92130, United States

Location

Unknown Facility

Denver, Colorado, 80206, United States

Location

Unknown Facility

Britain, Connecticut, 06050, United States

Location

Unknown Facility

West Hartford, Connecticut, 06117, United States

Location

Unknown Facility

Aventura, Florida, 33180, United States

Location

Unknown Facility

Boynton Beach, Florida, 33437, United States

Location

Unknown Facility

Clearwater, Florida, 33759, United States

Location

Unknown Facility

Hudson, Florida, 34667, United States

Location

Unknown Facility

Tampa, Florida, 33607, United States

Location

Unknown Facility

Alpharetta, Georgia, 30005, United States

Location

Unknown Facility

Atlanta, Georgia, 30342, United States

Location

Unknown Facility

Decatur, Georgia, 30034, United States

Location

Unknown Facility

Boise, Idaho, 83702, United States

Location

Unknown Facility

Boise, Idaho, 83712, United States

Location

Unknown Facility

Champaign, Illinois, 61820, United States

Location

Unknown Facility

Baton Rouge, Louisiana, 70808, United States

Location

Unknown Facility

Chesterfield, Missouri, 63017, United States

Location

Unknown Facility

Moorestown, New Jersey, 08057, United States

Location

Unknown Facility

Winston-Salem, North Carolina, 27103, United States

Location

Unknown Facility

Bismarck, North Dakota, 58501, United States

Location

Unknown Facility

Fargo, North Dakota, 58104, United States

Location

Unknown Facility

Cleveland, Ohio, 44122, United States

Location

Unknown Facility

Columbus, Ohio, 43231, United States

Location

Unknown Facility

Abington, Pennsylvania, 19001, United States

Location

Unknown Facility

West Chester, Pennsylvania, 19380, United States

Location

Unknown Facility

Jackson, Tennessee, 38305, United States

Location

Unknown Facility

Memphis, Tennessee, 38119, United States

Location

Unknown Facility

Memphis, Tennessee, 38120, United States

Location

Unknown Facility

Nashville, Tennessee, 37203, United States

Location

Unknown Facility

Irving, Texas, 75061, United States

Location

Unknown Facility

Salt Lake City, Utah, 84107, United States

Location

Unknown Facility

Kelowna, British Columbia, V1Y 3G8, Canada

Location

Unknown Facility

North Vancouver, British Columbia, V7M 2H5, Canada

Location

Unknown Facility

Penicton, British Columbia, V2A 5G8, Canada

Location

Unknown Facility

Halifax, Ontario, B3K 5R5, Canada

Location

Unknown Facility

Ottawa, Ontario, K1V 0Y3, Canada

Location

Unknown Facility

Toronto, Ontario, M5H 3P5, Canada

Location

Unknown Facility

Whitby, Ontario, L1N 4V6, Canada

Location

Unknown Facility

Windsor, Ontario, N8N 4X9, Canada

Location

Unknown Facility

Saskatoon, Saskatchewan, S7K 1N8, Canada

Location

Unknown Facility

Moscow, Russia

Location

Unknown Facility

Saint Petersburg, Russia

Location

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Jim Joffrion

    Lumara Health, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2008

First Posted

September 25, 2008

Study Start

February 1, 2007

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

March 6, 2012

Record last verified: 2012-03

Locations

CA(9)RU(2)US(38)