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Clinical Trials and Studies

Please find below a list of active, ongoing, non-Phase 1 studies sponsored by Endo. For studies that are required to be listed on www.clinicaltrials.gov, you can access additional detail about individual studies by clicking on the link or navigating to clinicaltrials.gov and search using the identifier number listed. For inquiries about our ongoing clinical trials, please contact us at clinicaltrials@endo.com.

For inquiries about clinical trial record retention, please contact us at RDeTMF@endo.com. Please do not destroy any records without written authorization from Endo. 


Study ID
Study Description
Intervention
Study Phase/Type
Recruitment Status* / ClinicalTrials.gov Identifier (if applicable)
EN3835-202 A Phase 2, Open-Label Extension Study of EN3835 in the Treatment of Edematous Fibrosclerotic Panniculopathy Collagenase clostridium histolyticum (CCH) Phase 2 Completed
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NCT02942160
EN3835-205 A Phase 2 Open-label Study of EN3835 in the Treatment of Edematous Fibrosclerotic Panniculopathy Collagenase clostridium histolyticum (CCH) Phase 2 Completed
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NCT03329989
EN3835-209 A Phase 2A, Open-Label Study Evaluating the Safety and Different Injection Techniques of EN3835 for the Treatment of Edematous Fibrosclerotic Panniculopathy (EFP) Collagenase clostridium histolyticum (CCH) Phase 2a Completed
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NCT03632993
EN3835-210 A Phase 2, Randomized, Double Blind, Placebo Controlled Study of the Safety and Efficacy of EN3835 for the Treatment of Adhesive Capsulitis of the Shoulder Collagenase clostridium histolyticum EN3835 (CCH) Phase 2 Recruiting
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NCT04496167
EN3835-212 A Phase 2a, Open Label Study to Assess the Impact of CCH Treatment of Buttock and Thigh Cellulite in Adult Females Using Photonumeric Scales, Magnetic Resonance Imaging and Histopathology Collagenase clostridium histolyticum (CCH) Phase 2a Terminated
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NCT04209530
EN3835-213 A Phase 2B, Open-Label Study to Explore Tissue Histopathology Following Subcutaneous Injection of Collagenase Clostridium Histolyticum Using An Abdominoplasty Model Collagenase clostridium histolyticum (CCH) Phase 2b Completed
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NCT04236635
EN3835-219 A Phase 2b, Open Label Durability Study of EN3835 Following Treatment of Edematous Fibrosclerotic Panniculopathy No treatment to be administered - Observational only Phase 2b Completed
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NCT03893890
EN3835-220 A Phase 2B, Open-Label Long-Term Durability Study of CCH Following Treatment of Edematous Fibrosclerotic Panniculopathy (Cellulite) No treatment to be administered - Observational only Phase 2b Completed
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NCT04381117
EN3835-223 An Observational, Double-blind (Sponsor Open), Long-term Study to Evaluate the Safety and Durability (Efficacy) of Response to EN3835 compared to Placebo in the Treatment of Adhesive Capsulitis of the Shoulder (Frozen Shoulder) Collagenase clostridium histolyticum EN3835 (CCH) Observational Recruiting
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NCT04680156
EN3835-224 A Phase 2 Multicenter, Open-Label, Randomized, Parallel-Group, Multiple-Dose Study to Assess the Effectiveness, Safety and Satisfaction With Collagenase Clostridium Histolyticum Grid Technique Injections of Buttock or Thigh Cellulite With Laxity in Adult Females Collagenase clostridium histolyticum (CCH) Phase 2 Active, not recruiting
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NCT04580303
EN3835-302 A Phase 3, Randomized, Double-blind, Placebo-Controlled Study of EN3835 in the Treatment of Edematous Fibrosclerotic Panniculopathy
(RELEASE-1)		 Collagenase clostridium histolyticum (CCH) Phase 3 Completed
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NCT03428750
EN3835-303 A Phase 3, Randomized, Double-blind, Placebo-Controlled Study of EN3835 in the Treatment of Edematous Fibrosclerotic Panniculopathy
(RELEASE-2)		 Collagenase clostridium histolyticum (CCH) Phase 3 Completed
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NCT03446781
EN3835-304 A Phase 3b, Open-Label, Long-Term Study to Evaluate the Safety and Temporal Pattern of Response of EN3835 in the Treatment of Edematous Fibrosclerotic Panniculopathy (EFP) Collagenase clostridium histolyticum (CCH) Phase 3b Active, not recruiting
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NCT03526549
EN3835-305 A Real World, Multicenter, Open-Label, Multiple Dose Study to Assess the Effectiveness of, and Satisfaction with, CCH Treatment of Buttocks or Thigh Cellulite in Adult Females Collagenase clostridium histolyticum (CCH) Phase 3b Completed
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NCT04170296
EN3835-401 (MOBI-1) Phase 4, Open-Label Study to Assess Effects of Mitigation Treatments on Bruising of CCH-Aaes Treatment of Buttock Cellulite in Adult Females QWO™ Phase 4 Active, not recruiting
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NCT04677712
PS4229-101 A Phase 1, Open-Label, Two-Arm, Parallel-Group, Pharmacokinetic Study on Plasma Clearance of Vasopressin in Healthy Volunteers Vasostrict® (vasopressin injection, USP) Phase 1 Completed
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NCT04093050


*Recruitment Status


Definition
Not yet recruiting

 participants are not yet being recruited
Recruiting

 participants are currently being recruited
Enrolling by invitation

 participants are being (or will be) selected from a predetermined population
Active, not recruiting study is ongoing (i.e., patients are being treated or examined), but participants are not currently being recruited or enrolled
Completed the study has concluded normally; participants are no longer being examined or treated (i.e., last patient's last visit has occurred)
Suspended

 recruiting or enrolling participants has halted prematurely but potentially will resume
Terminated recruiting or enrolling participants has halted prematurely and will not resume; participants are no longer being examined or treated
Withdrawn study halted prematurely, prior to enrollment of first participant

 


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