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| Sponsor: | Neurocrine Biosciences |
|---|---|
| Information provided by: | Neurocrine Biosciences |
| ClinicalTrials.gov Identifier: | NCT00109512 |
Purpose
Seventy-two subjects will be randomized to one of three treatment groups: placebo (capsules that will look like the study drug), 75 mg and 150 mg NBI-56418 in a 1:1:1 ratio. Study drug will be administered once daily for 12 weeks. After the last dose at the end of Week 12, follow-up will continue every 4 weeks for 12 weeks.
| Condition | Intervention | Phase |
|---|---|---|
|
Endometriosis |
Drug: NBI-56418 (GnRH antagonist) |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Phase II, Randomized, Double-Blind, Placebo-Controlled Study of NBI-56418 in Endometriosis |
Eligibility| Ages Eligible for Study: | 18 Years to 49 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Arizona | |
| Arizona Wellness Center for Women | |
| Phoenix, Arizona, United States, 85032 | |
| United States, California | |
| Genesis Center for Clinical Research | |
| San Diego, California, United States, 92103 | |
| Reproductive Science Center of the SF Bay Area | |
| San Ramon, California, United States, 94583 | |
| United States, Florida | |
| Women's Medical Research Group, LLC | |
| Clearwater, Florida, United States, 33759 | |
| United States, Illinois | |
| Women's Health Practice | |
| Champaign, Illinois, United States, 61820 | |
| Center for Women's Research | |
| Chicago, Illinois, United States, 60612 | |
| Institute for the Study and Treatment of Endometriosis | |
| Oak Brook, Illinois, United States, 60523 | |
| Falcon Center for Women | |
| Peoria, Illinois, United States, 61615 | |
| United States, Kentucky | |
| Bluegrass Clinical Research, Inc. | |
| Louisville, Kentucky, United States, 40291 | |
| United States, North Carolina | |
| Lyndhurst Gynecologic Associates | |
| Winston-Salem, North Carolina, United States, 27103 | |
| United States, Texas | |
| Medical Clinic of N. Texas | |
| Arlington, Texas, United States, 76012 | |
| United States, Utah | |
| Salt Lake Womens' Center | |
| Sandy, Utah, United States, 84070 | |
| United States, Virginia | |
| Tidewater Clinical Research | |
| Norfolk, Virginia, United States, 23502 | |
| National Clinical Research, Inc. | |
| Richmond, Virginia, United States, 23294 | |
| United States, Washington | |
| Northwest OB/GYN | |
| Spokane, Washington, United States, 99204 | |
More Information
| ClinicalTrials.gov Identifier: | NCT00109512 History of Changes |
| Other Study ID Numbers: | NBI-56418-0501 |
| Study First Received: | April 28, 2005 |
| Last Updated: | March 20, 2008 |
| Health Authority: | United States: Food and Drug Administration |
|
endometriosis pelvic pain painful periods dysmenorrhea painful menstruation |
GnRH agonist antagonist menstrual pain |
|
Endometriosis Genital Diseases, Female |