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

Endometriosis Clinical Trial

Official title:

A Phase 2, 12-Month, Open Label Extension Study to Evaluate the Safety of J867(5 mg QD) in Subjects With Endometriosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00160420
• Other study ID #: M02-408
• Status: Completed
• Phase: Phase 2
• First received: September 8, 2005
• Last updated: May 27, 2008
• Start date: December 2002
• Est. completion date: July 2004

Study information

• Verified date: May 2008
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationBelgium: Federal Agency for Medicines and Health Products, FAMHPGermany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: July 2004
• Est. primary completion date: July 2004
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Endometriosis

Intervention

Drug:
• Asoprisnil
5mg Tablet, oral Daily for 12 months

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in pelvic pain and dysmenorrhea assessed by visual analog scale.		Months 1,3,6,9,12 and final visit	No
Primary	Change from baseline in pelvic pain, dysmenorrhea, dyspareunia, pelvic tenderness and induration assessed by modified Biberoglu and Behrman grading scale.		Months 3,6,9,12 and final visit	No
Secondary	Percentage of subjects with amenorrhea.		Throught treatment period.	No