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Sponsored by: |
Neurocrine Biosciences |
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Information provided by: | Neurocrine Biosciences |
ClinicalTrials.gov Identifier: | NCT00437658 |
This study is designed to see how a research compound (NBI-56418) works compared to DMPA-SC (also known as depo-provera) in women with endometriosis and to see how both may affect bone mineral density.
Condition | Intervention | Phase |
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Endometriosis |
Drug: NBI-56418 Drug: depo-subQ provera 104 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase II, Randomized, Double-Blind, Randomized, Active-Controlled Study to Assess the Safety and Efficacy of NBI-56418 in Subjects With Endometriosis |
Ages Eligible for Study: | 18 Years to 49 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | NBI-56418-0603 |
Study First Received: | February 16, 2007 |
Last Updated: | April 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00437658 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Genital Diseases, Female Medroxyprogesterone 17-Acetate Antineoplastic Agents, Hormonal Contraceptive Agents Contraceptives, Oral |
Contraceptive Agents, Female Medroxyprogesterone Endometriosis Contraceptive Agents, Male |
Medroxyprogesterone 17-Acetate Antineoplastic Agents, Hormonal Antineoplastic Agents Contraceptive Agents Contraceptives, Oral Physiological Effects of Drugs Contraceptive Agents, Female Endometriosis |
Reproductive Control Agents Contraceptive Agents, Male Pharmacologic Actions Genital Diseases, Female Therapeutic Uses Contraceptives, Oral, Synthetic Medroxyprogesterone |