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OpenTrials
Completed

NCT Number: NCT00758953

Pain Associated With Endometriosis

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

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Key information

Conditions

Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Kelowna, British Columbia, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Danazol Once Weekly

Drug

semi-solid

Danazol Twice Weekly

Drug

semi-solid

Placebo Once Weekly

Drug

semi-solid

Placebo Twice Weekly

Drug

semi-solid

Primary outcomes

  1. Pain associated with endometriosis

    Time frame: 3 months of treatment

Sponsors and collaborators

Lead sponsor

Lumara Health, Inc.

Industry

Registry information

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Sep 25, 2008
Registry last updated
Mar 6, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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