Pain Associated With Endometriosis

NCT ID: NCT00758953

Last Updated: 2012-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2009-01-31

Brief Summary

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

Detailed Description

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Conditions

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Endometriosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Group Type EXPERIMENTAL

Danazol Once Weekly

Intervention Type DRUG

semi-solid

2

Group Type EXPERIMENTAL

Danazol Twice Weekly

Intervention Type DRUG

semi-solid

3

Group Type PLACEBO_COMPARATOR

Placebo Once Weekly

Intervention Type DRUG

semi-solid

4

Group Type PLACEBO_COMPARATOR

Placebo Twice Weekly

Intervention Type DRUG

semi-solid

Interventions

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Danazol Once Weekly

semi-solid

Intervention Type DRUG

Danazol Twice Weekly

semi-solid

Intervention Type DRUG

Placebo Once Weekly

semi-solid

Intervention Type DRUG

Placebo Twice Weekly

semi-solid

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Lumara Health, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jim Joffrion

Role: STUDY_DIRECTOR

Lumara Health, Inc.

Locations

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Chandler, Arizona, United States

Site Status

Phoenix, Arizona, United States

Site Status

Phoenix, Arizona, United States

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Little Rock, Arkansas, United States

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Carmichael, California, United States

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San Diego, California, United States

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San Diego, California, United States

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San Diego, California, United States

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Denver, Colorado, United States

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Britain, Connecticut, United States

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West Hartford, Connecticut, United States

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Aventura, Florida, United States

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Boynton Beach, Florida, United States

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Clearwater, Florida, United States

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Hudson, Florida, United States

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Tampa, Florida, United States

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Alpharetta, Georgia, United States

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Atlanta, Georgia, United States

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Decatur, Georgia, United States

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Boise, Idaho, United States

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Boise, Idaho, United States

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Champaign, Illinois, United States

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Baton Rouge, Louisiana, United States

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Chesterfield, Missouri, United States

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Moorestown, New Jersey, United States

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Winston-Salem, North Carolina, United States

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Bismarck, North Dakota, United States

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Fargo, North Dakota, United States

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Cleveland, Ohio, United States

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Columbus, Ohio, United States

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Abington, Pennsylvania, United States

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West Chester, Pennsylvania, United States

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Jackson, Tennessee, United States

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Memphis, Tennessee, United States

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Memphis, Tennessee, United States

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Nashville, Tennessee, United States

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Irving, Texas, United States

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Salt Lake City, Utah, United States

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Kelowna, British Columbia, Canada

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North Vancouver, British Columbia, Canada

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Penicton, British Columbia, Canada

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Halifax, Ontario, Canada

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Ottawa, Ontario, Canada

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Toronto, Ontario, Canada

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Whitby, Ontario, Canada

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Windsor, Ontario, Canada

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Saskatoon, Saskatchewan, Canada

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Moscow, , Russia

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Saint Petersburg, , Russia

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Countries

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United States Canada Russia

Other Identifiers

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DZ2-201-601-725036

Identifier Type: -

Identifier Source: org_study_id

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