Completed Clinical Trial and Study Results

Endo is committed to supporting transparent and responsible scientific disclosure regarding its clinical studies. To that end, Endo registers all Applicable Clinical Trials on clinicaltrials.gov, provides status updates, and is transparent about study results. Endo also posts study results of additional Endo-sponsored studies on this website, which can be viewed in the attached files.

For results on completed clinical trials that have been sponsored by Endo, please go to www.clinicaltrials.gov or follow the links provided below. Results for Postmarketing Commitment and Requirement studies are posted on the Postmarketing Commitments and Requirements webpage.

 

Study ID Study Description
Study Treatment


Clinical Study Results

303 Vantas Implant Retrieval Study VANTAS® (histrelin acetate) subcutaneous implant PDFicon.png
AUX-CC-802 A Phase 3, Open-Label Study of the Safety and Effectiveness of AA4500 Administered Twice Per Treatment Cycle for Up to Four Treatment Cycles (2 X 4) In Men With Peyronie's Disease XIAFLEX® (collagenase clostridium histolyticum) newWindow_gray.png NCT01243411
AUX-CC-806 A Phase 3, Open-Label Study of the Safety and Effectiveness of AA4500 Administered Twice Per Treatment Cycle for Up to Four Treatment Cycles (2 X 4) In Men With Peyronie's Disease XIAFLEX® (collagenase clostridium histolyticum) newWindow_gray.png NCT01685437
AUX-CC-807 A phase 3b, open-label pilot study to evaluate the safety and effectiveness of up to four treatment cycles of AA4500 in combination with the ErecAid® Esteem® Manual Vacuum Therapy System in men with Peyronie’s disease XIAPEX® (AA4500 [collagenase clostridium histolyticum]) newWindow_gray.png EudraCT 2013-005384-66
AUX-CC-860 Year 5 Year 5 Final Annual Report of A Long-Term Follow-Up of Subjects Treated With AA4500 in Studies AUX-CC-854, AUX-CC-856, AUX-CC-857/AUX-CC-858, and AUX-CC-859 XIAFLEX® (collagenase clostridium histolyticum) PDFicon.png
AUX-CC-862 Retreatment of Recurrent Contractures in Joints Effectively Treated with AA4500 (Collagenase Clostridium Histolyticum [XIAFLEX®/XIAPEX®]) in an Auxilium-Sponsored Phase 3 Study in the United States, Australia, and Europe XIAFLEX® (collagenase clostridium histolyticum) newWindow_gray.png NCT01498640
AUX-CC-864 An open-label study to assess the safety and efficacy of concurrent administration of two injections of AA4500 0.58 mg into the same hand of subjects with multiple Dupuytren's contractures XIAFLEX® (collagenase clostridium histolyticum) newWindow_gray.png NCT01407068
AUX-CC-901 COmmunity RegistRy Study Evaluating Dupuytren’s Contracture Treatment: A Prospective, Observational, Longitudinal, Multicenter Study of Treatment Patterns and Outcomes in Patients with Dupuytren's Contracture XIAFLEX® (collagenase clostridium histolyticum) PDFicon.png
AUX-CC-902 A multicenter observational study of the real life effectiveness and safety of Xiapex® in the treatment of Dupuytren's disease in Belgium XIAFLEX®/XIAPEX® (collagenase clostridium histolyticum) PDFicon.png
EN3202-012 Double-Blind, Placebo-Controlled, Parallel-Group Comparison of the Efficacy, Opioid Dose Sparing Effects and Safety of Controlled Release Oxymorphone and Placebo in Patients with Postsurgical Pain Following Knee Arthroplasty Oxymorphone controlled-release tablets PDF icon
EN3202-015 Double-Blind, Placebo Controlled, Parallel Group, Dose Ranging Comparison of the Efficacy and Safety of Controlled Release Oxymorphone, Controlled Release Oxycodone (OxyContin®) and Placebo in the Treatment of Osteoarthritis of the Knee and/or Hip Oxymorphone controlled-release tablets PDF icon
EN3202-016 Evaluation of the Efficacy and Safety of Numorphan® CR (Oxymorphone HCl Controlled Release) Relative to Placebo and OxyContin® (Oxycodone HCl Controlled Release) in Subjects with Chronic Low Back Pain OPANA® ER (oxymorphone hydrochloride) Extended-Release Tablets PDF icon
EN3202-017 Open Label, Sequential Crossover Evaluation of the Analgesic Dose Equivalence, Efficacy and Safety of Controlled-Release Oxymorphone (Numorphan® CR) Relative to Controlled-Release Oxycodone (OxyContin®) and Controlled-Release Morphine (MS Contin®) in Patients With Cancer Pain OPANA® ER (oxymorphone hydrochloride) Extended-Release Tablets PDF icon
EN3202-018 A Randomized, Double-Blind, Two-Period Crossover Trial Comparing the Safety and Effectiveness of Numorphan® CR (oxymorphone controlled-release tablets) and MS Contin® (morphine sulfate controlled release tablets) for the Relief of Moderate to Severe Pain in Patients with Cancer OPANA® ER (oxymorphone hydrochloride) Extended-Release Tablets PDF icon
EN3202-019 A Randomized, Double-Blind, Two-Period Crossover Study Comparing the Efficacy, Safety and Tolerability of Numorphan® CR (Oxymorphone HCl, Controlled Release) and OxyContin® (Oxycodone HCl, Controlled Release) in Cancer Patients Who Require Chronic Opioid Treatments OPANA® ER (oxymorphone hydrochloride) Extended-Release Tablets PDF icon
EN3202-020 A Multicenter, Open Label Extension Study to Evaluate the Long-term Safety and Effectiveness of Numorphan® CR in Patients with Chronic Pain OPANA® ER (oxymorphone hydrochloride) Extended-Release Tablets PDF icon
EN3202-021 An Open-Label Extension Study to Evaluate the Long-Term Safety, Tolerability and Analgesic Efficacy of Numorphan® CR (oxymorphone HCl controlled release) in Subjects With Cancer Pain or Chronic Lower Back Pain OPANA® ER (oxymorphone hydrochloride) Extended-Release Tablets PDF icon
EN3202-022 An Open-Label Assessment of the Long-Term Safety and Utility of Numorphan® CR for the Relief of Moderate to Severe Pain in Patients with Cancer OPANA® ER (oxymorphone hydrochloride) Extended-Release Tablets PDF icon
EN3202-025 Double-Blind, Placebo Controlled, Parallel Group, Dose Ranging Comparison of the Efficacy and Safety of Extended Release Oxymorphone and Placebo in the Treatment of Osteoarthritis of the Knee and/or Hip OPANA® ER (oxymorphone hydrochloride) Extended-Release Tablets PDF icon
EN3202-028 Safety and Efficacy Study of Oxymorphone Extended Release (ER) in Opioid-Naive Patients With Chronic Pain OPANA® ER (oxymorphone hydrochloride) Extended-Release Tablets PDFicon.png
EN3202-029 Long-term Effectiveness and Safety Study of Oxymorphone Extended Release in Patients With Cancer or Neuropathic Pain OPANA® ER (oxymorphone hydrochloride) Extended-Release Tablets PDFicon.png
EN3202-031 Efficacy and Safety of Oxmorphone Extended Release in Opioid-Naive Patients with Chronic Low Back Pain OPANA® ER (oxymorphone hydrochloride) Extended-Release Tablets PDFicon.png
EN3202-032 Efficacy and Safety of Oxymorphone Extended Release in Opioid-Experienced Patients With Chronic Low Back Pain OPANA® ER (oxymorphone hydrochloride) Extended-Release Tablets PDFicon.png
EN3202-402 Study to Compare Subjective and Objective Effects of Oxymorphone Extended-Release (OPANA ER) Versus Oxycodone Controlled-Release (OxyContin) OPANA® ER (oxymorphone hydrochloride) Extended-Release Tablets newWindow_gray.png NCT00955110
EN3203-004 Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose Ranging Comparison of the Analgesic Efficacy and Safety of Numorphan® IR (Oxymorphone HCl Immediate Release), Percolone, and Placebo in Patients With Postsurgical Pain Following Orthopedic Total Hip and Knee Replacement Oxymorphone hydrochloride immediate-release tablets PDF icon
EN3203-005 A Multicenter, Randomized, Double-Blind, Placebo and Active Controls, Single-Dose Study of Oxymorphone IR and Oxycodone IR in Patients With Pain Following Orthopedic Surgery. Oxymorphone hydrochloride immediate-release tablets PDF icon
EN3203-008 Post-operative Knee Surgery Efficacy and Safety Study OPANA® (oxymorphone hydrochloride) Tablets PDFicon.png
EN3203-009 Efficacy and Safety of Oxymorphone Immediate Release in Post-surgical Acute Pain OPANA® (oxymorphone hydrochloride) Tablets PDFicon.png
EN3220-006 Open-label Efficacy Study of Topical Lidocaine Patch in Low Back Pain LIDODERM® (Lidocaine Patch 5%) PDFicon.png
EN3220-008 A Study of the Effectiveness and Safety of Lidoderm® as Add-on Treatment in Patients with Postherpetic Neuralgia, Diabetic Neuropathy, or Low Back Pain LIDODERM® (Lidocaine Patch 5%) PDFicon.png
EN3220-009 A Study of Lidocaine Patch 5% Alone, Gabapentin Alone, and Lidocaine Patch 5% and Gabapentin in Combination for the Relief of Pain in Patients with Diverse Peripheral Neuropathic Pain Conditions LIDODERM® (Lidocaine Patch 5%) PDFicon.png
EN3220-011 Pilot Study of the Efficacy and Safety of Lidoderm Patch in the Treatment of Low Back Pain LIDODERM® (Lidocaine Patch 5%) PDFicon.png
EN3220-012 Lidocaine Patch Versus Celecoxib in Pain From Osteoarthritis of the Knee LIDODERM® (Lidocaine Patch 5%) PDFicon.png
EN3220-013 Lidocaine Patch 5% Versus Celecoxib 200 mg in Chronic Axial Low Back Pain LIDODERM® (Lidocaine Patch 5%) PDFicon.png
EN3225-001 Open-Label Pilot Study Assessing the Efficacy and Safety of New Formulations of Percocet® in the Treatment of Low Back Pain PERCOCET® (oxycodone hydrochloride and acetaminophen USP) Tablets PDF icon
EN3225-002 A Single-center, Randomized, Double-blind, Placebo-controlled, Single-dose Study of the Safety and Efficacy of Low-dose Percocet® Compared to OxyContin® in Patients With Acute Pain Following Third Molar Extraction PERCOCET® (oxycodone hydrochloride and acetaminophen USP) Tablets PDF icon
EN3225-003 A Single-Center, Randomized, Double-Blind, Placebo-Controlled, Single-Dose Study of the Safety and Efficacy of Low-Dose Percocet® in Patients With Acute Pain Following Third Molar Extraction PERCOCET® (oxycodone hydrochloride and acetaminophen USP) Tablets PDF icon
EN3260-001 Pilot Study of Lidocaine 5% Patch Versus Placebo in Patients With Osteoarthritis Pain of the Knee LIDODERM® (Lidocaine Patch 5%) PDFicon.png
EN3260-003 Efficacy and Safety of the Lidoderm Patch 5% Applied to Patients With Osteoarthritis of the Knee LIDODERM® (Lidocaine Patch 5%) newWindow_gray.png NCT00589979
EN3261-001 A Study Comparing the Efficacy and Safety of Lidocaine 5% Patch With Placebo in Patients With Chronic Axial Low Back Pain LIDODERM® (Lidocaine Patch 5%) PDFicon.png
EN3266-401 Effectiveness and Safety of Frovatriptan for the Management (Acute Treatment) of Menstrual Migraine FROVA® (frovatriptan succinate) Tablets PDFicon.png
EN3272-301 Safety and Efficacy Study of Lidoderm (Lidocaine Patch 5%) Compared with Placebo in Treating Moderate to Severe Pain Associated With Carpal Tunnel Syndrome LIDODERM® (Lidocaine Patch 5%) PDFicon.png
EN3288-108 An Open-Label, Randomized, Single-Dose, Six Period, Crossover Study to Evaluate the Relative Bioavailability of EN3288 40 mg Intact and After Physical Tampering Using Various Methods Compared with OPANA® 10 mg (4 × 10 mg) in Healthy Adult Subjects OPANA® ER (oxymorphone hydrochloride) Extended-Release Tablets PDF icon
EN3288-109 A Randomized, Single-Dose, Double-Blind, Double-Dummy, Four-Period, Crossover Study to Evaluate the Relative Bioavailability and Subjective Effects of EN3288 40 mg Administered Intact and After Mastication Compared With OPANA® ER 40 mg Administered After Mastication and With OPANA® 40 mg (4 × 10 mg) Administered Intact in Healthy Non-Dependent Recreational Oral Prescription Opioid Users Experienced in Mastication of Extended-Release Opioid Formulations OPANA® ER (oxymorphone hydrochloride) Extended-Release Tablets PDF icon
EN3288-113 A Double-blind, Dose-Ranging, Pilot Study to Evaluate the Safety, Subjective Effects, and Pharmacokinetics of Oxymorphone Hydrochloride in Healthy Subjects Who Recreationally Administer Opioids Intranasally OPANA® ER (oxymorphone hydrochloride) Extended-Release Tablets PDF icon
EN3288-114 A Randomized Double-Blind, Single-Dose, Placebo-Controlled, Four-Period, Crossover Study to Evaluate the Subjective Effects and Systemic Exposure of Manipulated OPANA® ER Administered Intranasally Compared with Oxymorphone Hydrochloride Powder Administered Intranasally in Healthy, Non-Dependent Subjects Who Recreationally Administer Opioids Intranasally OPANA® ER (oxymorphone hydrochloride) Extended-Release Tablets PDF icon
EN3288-901 Assessment of the ease with which experienced controlled-release prescription opioid abusers prepare a tamper-resistant formulation for intravenous use: comparison between OPANA® ER and oxymorphone HCl extended-release tamper-resistant tablets OPANA® ER (oxymorphone hydrochloride) Extended-Release Tablets PDF icon
EN3288-902 Assessment of the ease with which experienced controlled-release prescription opioid abusers prepare a tamper-resistant formulation for intranasal use: comparison between OPANA® ER and oxymorphone HCl extended-release tamper-resistant tablets OPANA® ER (oxymorphone hydrochloride) Extended-Release Tablets PDF icon
EN3319-301 Effectiveness, Safety, and Tolerability Study of Oxymorphone Immediate Release (IR) Oral Liquid in Opioid Tolerant Pediatric Subjects Oxymorphone hydrochloride immediate-release oral liquid study terminated
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NCT01206907
EN3326-300 Former 03-CPP-HIS-300 Phase III Efficacy and Safety Study of Histrelin Subcutaneous Implant in Children With Central Precocious Puberty SUPPRELIN® LA (histrelin acetate) subcutaneous implant PDFicon.png
EN3329-A9301/A9302 Intravesical AD 32 (valrubicin) in Patients With Carcinoma In Situ of the Bladder Who Have Failed or Have Recurrence Following Treatment with Bacillus Calmette-guerin (BCG) Valstar® (valrubicin) Sterile Solution PDFicon.png
EN3330-301 Phase III Study to Evaluate Efficacy and Safety of Histrelin Subdermal Implant in Men With Advanced Prostate Cancer Vantas® (histrelin acetate) subcutaneous implant PDFicon.png
EN3330-302 Phase III Study of Histrelin Subdermal Implant in Patients With Advanced Metastatic Prostate Cancer Vantas® (histrelin acetate) subcutaneous implant PDFicon.png
FOR01C A Study of Fortigel Testosterone Gel 2% in Males With Low Testosterone FORTESTA® (testosterone) Gel newWindow_gray.png NCT00522431
IP157-001 Long-term Safety Study of Intramuscular Injections of 750 mg and 1000 mg Testosterone Undecanoate in Hypogonadal Men AVEED® (testosterone undecanoate) injection newWindow_gray.png NCT00467870
IP157-003 Phase I, Double-Blind Study to Evaluate the Allergic Potential of NEBIDO® and Formulation Components in Patients Who Have Exhibited Anaphylactic-Like Reactions Following Intramuscular Injection of NEBIDO® NEBIDO® (testosterone undecanoate)*
*Bayer Pharma AG
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VML 251-3MRM02 A Controlled Trial to Investigate the Efficacy and Safety of Frovatriptan to Prevent Menstrual Migraine FROVA® (frovatriptan succinate) Tablets PDFicon.png
VML 251-3MAM03 Safety and Tolerability of Frovatriptan in Prevention of Menstrually Associated Migraine (MAM) Headaches FROVA® (frovatriptan succinate) Tablets PDFicon.png

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