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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00160420

Enrollment

Registered

2005-09-12

Start date

2002-12-31

Completion date

2004-07-31

Last updated

2008-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometriosis

Keywords

Pelvic pain, Dysmenorrhea, Dyspareunia, Infertility, asoprisnil

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.

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.

Interventions

DRUGAsoprisnil

5mg Tablet, oral Daily for 12 months

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 40 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Change from baseline in pelvic pain and dysmenorrhea assessed by visual analog scale.	Months 1,3,6,9,12 and final visit
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

Secondary

Measure	Time frame
Percentage of subjects with amenorrhea.	Throught treatment period.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026