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This is a Phase II, multicenter, randomized, double-blind, placebo-controlled, parallel-group study with subjects randomized to one of three treatment groups, placebo, 75 mg and 150 mg in a 1:1:1 ratio. Study drug was administered once daily for 12 weeks. After the last dose at the end of Week 12, follow-up continued every 4 weeks for 12 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| placebo | Placebo Comparator |
| |
| NBI-56418 75 mg | Experimental |
| |
| NBI-56418 150 mg | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NBI-56418 (GnRH antagonist) | Drug |
| ||
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Total Composite Pelvic Signs and Symptom Scale (CPSSS) scores | This scale is used to assess the signs (pelvic tenderness and induration) and symptoms (nonmenstrual pelvic pain, dysmenorrhea and dyspareunia) associated with endometriosis. | Every 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Endometriosis Health Profile-5 (EHP-5) | The EHP-5 assesses quality of life. | Every 4 weeks |
| Visual Analog Scale (VAS) scores | VAS measures endometriosis pain. |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Laura Williams, MD | Abbott | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 56266 | Phoenix | Arizona | 85032 | United States | ||
| Site Reference ID/Investigator# 55210 |
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| Drug |
|
| Every 4 weeks |
| Number of Subjects with Adverse Events | Up to 24 weeks |
| Clinical Laboratory Tests | Up to 24 weeks |
| Vital Sign Measurements | Up to 24 weeks |
| Physical Examinations | Up to 24 weeks |
| Electrocardiogram (ECG) tracings | Up to 24 weeks |
| San Diego |
| California |
| 92103 |
| United States |
| Site Reference ID/Investigator# 55214 | San Ramon | California | 94566 | United States |
| Site Reference ID/Investigator# 56267 | Clearwater | Florida | 33759 | United States |
| Site Reference ID/Investigator# 56270 | Champaign | Illinois | 61820 | United States |
| Site Reference ID/Investigator# 56273 | Chicago | Illinois | 60612 | United States |
| Site Reference ID/Investigator# 56269 | Oak Brook | Illinois | 60523 | United States |
| Site Reference ID/Investigator# 56271 | Peoria | Illinois | 61615 | United States |
| Site Reference ID/Investigator# 56272 | Louisville | Kentucky | 40291 | United States |
| Site Reference ID/Investigator# 55213 | Winston-Salem | North Carolina | 27103 | United States |
| Site Reference ID/Investigator# 55211 | Arlington | Texas | 76012 | United States |
| Site Reference ID/Investigator# 56268 | Sandy City | Utah | 84070 | United States |
| Site Reference ID/Investigator# 56274 | Richmond | Virginia | 23294 | United States |
| Site Reference ID/Investigator# 55212 | Virginia Beach | Virginia | 23451 | United States |
| Site Reference ID/Investigator# 56275 | Spokane | Washington | 99204 | United States |
| ID | Term |
|---|---|
| D004715 | Endometriosis |
| D017699 | Pelvic Pain |
| D004412 | Dysmenorrhea |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008599 | Menstruation Disturbances |
| D010335 | Pathologic Processes |
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