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A Long-Term Study to Evaluate the Safety of Asoprisnil in the Treatment of Women With Endometriosis From Study M01-398

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00160420
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : May 29, 2008
Sponsor:
Information provided by:
Abbott

Brief Summary:
The objective of this study is to determine the long-term safety of asoprisnil 5 mg for 12 months in women with endometriosis from study M01-398.

Condition or disease Intervention/treatment Phase
Endometriosis Drug: Asoprisnil Phase 2

Detailed Description:
Endometriosis, the presence of endometrial tissue outside the uterus, is a progressive, estrogen-dependent disease that occurs in menstruating women of reproductive age. Although all major endometriosis therapies are effective for the treatment of pain, no single treatment is superior to others in terms of efficacy. The major drawbacks of the current medical therapies are severe side effects such as hot flushes and osteoporosis. The objective of this study is to determine the long-term safety of asoprisnil 5 mg daily for 12 months in women with endometriosis, after an initial 12 weeks in study M01-398. The safety will be based on assessments of the endometrium, lipid profiles, adverse events, and changes from baseline laboratory values and vital signs.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 73 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, 12-Month, Open Label Extension Study to Evaluate the Safety of J867(5 mg QD) in Subjects With Endometriosis
Study Start Date : December 2002
Actual Primary Completion Date : July 2004
Actual Study Completion Date : July 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis

Arm Intervention/treatment
Experimental: 1 Drug: Asoprisnil
5mg Tablet, oral Daily for 12 months




Primary Outcome Measures :
  1. Change from baseline in pelvic pain and dysmenorrhea assessed by visual analog scale. [ Time Frame: Months 1,3,6,9,12 and final visit ]
  2. Change from baseline in pelvic pain, dysmenorrhea, dyspareunia, pelvic tenderness and induration assessed by modified Biberoglu and Behrman grading scale. [ Time Frame: Months 3,6,9,12 and final visit ]

Secondary Outcome Measures :
  1. Percentage of subjects with amenorrhea. [ Time Frame: Throught treatment period. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Completed 3 months of dosing and Month 3 procedures in study M01-398
  • Otherwise in good health
  • Month 3 (M01-398) ultrasound reveals no significant gynecologic disorder

Exclusion Criteria:

  • Any abnormal lab or procedure result the study-doctor considers important
  • Anticipated need for excluded hormonal therapy or unapproved narcotics

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00160420


Sponsors and Collaborators
Abbott
Investigators
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Study Chair: Medical Director Abbott
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Responsible Party: Cynthia Mattia-Goldberg, Abbott
ClinicalTrials.gov Identifier: NCT00160420    
Other Study ID Numbers: M02-408
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: May 29, 2008
Last Verified: May 2008
Keywords provided by Abbott:
Pelvic pain
Dysmenorrhea
Dyspareunia
Infertility
asoprisnil
Additional relevant MeSH terms:
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Endometriosis
Genital Diseases, Female