A Study to Evaluate the Safety and Effectiveness of Three Asoprisnil Doses in the Treatment of Women With Endometriosis

Endometriosis Clinical Trial

Official title:

A Phase II Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of J867 Administered in Patients With Endometriosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00160446
• Other study ID #: M99-110
• Status: Completed
• Phase: Phase 2
• First received: September 8, 2005
• Last updated: May 27, 2008
• Start date: May 2000
• Est. completion date: July 2001

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, FAMHP
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to determine the safety and effectiveness of three doses of asoprisnil, compared to placebo, in the treatment of women with endometriosis.

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 safety and efficacy of asoprisnil 5, 10, and 25 mg tablets, compared to placebo, administered daily for 12 weeks to women with endometriosis, by assessing whether asoprisnil administration diminishes the pelvic pain, dysmenorrhea, dyspareunia, excessive bleeding, and analgesic use associated with this disease and lessens the subjects' perceived pain symptoms. Otherwise healthy women with surgically confirmed endometriosis will be enrolled.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: July 2001
• Est. primary completion date: July 2001
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Surgically confirmed endometriosis

• History of menstrual cycles between 26 and 32 days

• Otherwise in good health

• Age 18-40 years, inclusive

• Subject had pain graded at Screening and Day 1 according to a scale suggested by Biberoglu and Berhman5 in at least one of the following categories:

1. moderate or severe pelvic pain not related to menstruation, OR

2. moderate or severe dysmenorrhea, OR

3. moderate or severe pelvic tenderness elicited on pelvic examination accompanied by non-menstrual pelvic pain.

• Subject agrees to double barrier method of contraception

Exclusion Criteria:

• Any abnormal lab or procedure result the study-doctor considers important

• History of undiagnosed uterine bleeding or gynecological disorder

• Severe reaction(s) to hormone therapy

• History of osteoporosis or other metabolic bone disease

• Subject currently breast feeding

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Endometriosis

Intervention

Drug:
• Asoprisnil
5mg Tablet, oral Daily for 12 weeks
• Asoprisnil
10 mg Tablet, oral Daily for 12 weeks
• Asoprisnil
25 mg Tablet, oral Daily for 12 weeks
• Placebo
Tablet, oral Daily for 12 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain (dysmenorrhea, dyspareunia, pelvic pain) measured by daily diary		Mean change from baseline to Months 1, 2, 3	No
Secondary	Global efficacy question		Final visit	No
Secondary	Pain (dysmenorrhea, dyspareunia, pelvic pain) pelvic tenderness and induration evaluated during office visits using modified Biberoglu and Behrman grading scale		Each monthly visit	No