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

Endometriosis Clinical Trial

Official title:

A Phase II, 3-Month, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Three Doses of J867 (0.5, 1.5 and 5 mg QD) Versus Placebo in Subjects With Endometriosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00160433
• Other study ID #: M01-398
• Status: Completed
• Phase: Phase 2
• First received: September 8, 2005
• Last updated: May 27, 2008
• Start date: August 2002
• Est. completion date: June 2003

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 safety and efficacy of 3 asoprisnil doses (0.5 mg, 1.5 mg, and 5.0 mg) for 12 weeks in 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 if a dose-response relationship exists between asoprisnil and endometriosis-associated pelvic pain and dysmenorrhea or to establish the lowest effective dose of asoprisnil in the treatment of pelvic pain and dysmenorrhea associated with endometriosis. Women with surgically confirmed endometriosis will be administered asoprisnil 0.5, 1.5, and 5 mg tablets or a placebo once daily for 3 months and efficacy will be assessed by improvement in pelvic pain, dysmenorrhea, dyspareunia, bleeding, analgesic use, global efficacy, and quality of life questionnaires. 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: 131
• Est. completion date: June 2003
• Est. primary completion date: June 2003
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Premenopausal women (18-40 years)

• Surgically confirmed endometriosis within 3 years

• History of menstrual cycles between 21 and 35 days

• Moderate or severe pelvic pain OR moderate or severe dysmenorrhea OR moderate or severe pelvic tenderness accompanied by at least mild non-menstrual pelvic pain

• Negative pregnancy test

• Agrees to use double barrier method of contraception

• Pap smear with no evidence of malignancy or pre-malignant changes

• Ultrasound with no significant gynecological disorder.

• Otherwise in good health

Exclusion Criteria:

• Less than 3 months after having a baby or breast-feeding

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

• Severe reaction(s) to hormone therapy

• Anticipated need for excluded hormonal therapy or unapproved narcotics

• Current use of an IUD

• History or prolactinoma

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
0.5 mg Tablet, oral Daily for 12 weeks
• Asoprisnil
1.5 mg Tablet, oral Daily for 12 weeks
• Asoprisnil
5.0 mg Tablet, oral Daily for 12 weeks
• Placebo
Tablet, oral Daily for 12 weeks

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Abbott	Jenapharm GmbH & Co. KG

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change from baseline in pelvic pain as assessed by daily diary		Final month	No
Primary	Mean change from baseline in dysmenorrhea as assessed by daily diary		Final month	No
Secondary	Change from baseline in pelvic pain and dysmenorrhea scores from the daily diary.		Months 1,2,3 and Months 1-3	No
Secondary	Change from baseline in dyspareunia and the combined pelvic pain/dysmenorrhea scores from the daily diary.		Months 1,2,3 and Months 1-3 and the Final Month	No
Secondary	Change from baseline in the percentage of days with mild or greater combined pelvic pain/dysmenorrhea and moderate or greater combined pelvic pain/dysmenorrhea based on the daily diary.		Months 1,2,3 and Months 1-3 and Final Month	No
Secondary	Change from baseline for pelvic pain, dysmenorrhea, dyspareunia, pelvic tenderness and induration scores assessed by the modified Biberoglu and Behrman pain scale.		Months 1,2,3 and Final Visit	No
Secondary	Change from baseline in pelvic pain and dysmenorrhea assessed via the Visual Analog Scale.		Months 1,2,3 and Final Visit	No
Secondary	Percent of subjects with "Yes" response to Global Efficacy question.		Months 1,2,3 and Final Visit	No
Secondary	Change from baseline in analgesic use scores.		Months 1,2,3, Months 1-3 and Final Visit	No
Secondary	Percent of subjects who achieve amenorrhea.		Throughout the treatment period	No
Secondary	Change from baseline in Endometriosis Health Profile-30 (EHP-30) scores.		Month 3	No
Secondary	Change from baseline in Short Form-36 scores.		Month 3	No
Secondary	Change from baseline in both monthly bleeding scores and percentage of days with bleeding or spotting.		Months 1-3	No
Secondary	Change from Screening menses in bleeding intensity.		First post-treatment menses	No
Secondary	Change from baseline in hemoglobin and hematocrit.		Months 1,2,3 and Final Visit	No