Pain Associated With Endometriosis

This study has been completed.
Information provided by (Responsible Party):
KV Pharmaceutical Company Identifier:
First received: September 23, 2008
Last updated: March 2, 2012
Last verified: March 2012

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
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:

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
Experimental: 2 Drug: Danazol Twice Weekly
Placebo Comparator: 3 Drug: Placebo Once Weekly
Placebo Comparator: 4 Drug: Placebo Twice Weekly


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

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 identifier: NCT00758953

  Show 49 Study Locations
Sponsors and Collaborators
KV Pharmaceutical Company
Study Director: Jim Joffrion KV Pharmaceutical Company
  More Information

No publications provided

Responsible Party: KV Pharmaceutical Company 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:
Genital Diseases, Female
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions processed this record on April 16, 2014