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NCT03893890 · ClinicalTrials.gov registry record
Durability and Safety of EN3835 in the Treatment of EFP (Cellulite) in Women
A clinical trial, sponsored by Endo USA Inc., a Keenova Therapeutics Company.
- Completed
- Registry status
- 8
- Enrollment target
NCT03893890: Completed study, sponsored by Endo USA Inc., a Keenova Therapeutics Company.
NCT03893890 is a clinical trial that has completed, run by Endo USA Inc., a Keenova Therapeutics Company. The registered enrollment target is 8 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03893890 has completed, sponsored by Endo USA Inc., a Keenova Therapeutics Company.
- COMPLETED
- Registry status
- 8 participants
- Enrollment target
Study Summary
This is a Phase 2b, rollover, long-term study to evaluate the safety and duration of efficacy of EN3835 in the treatment of women with EFP. Subjects who participated in and completed studies EN3835-201 and EN3835-202 and had composite improvement of at least 2 levels on both the CR-PCSS and PR-PCSS in study EN3835-201 will be eligible for this study.
Primary Outcome
Change from baseline (pre-dose, Day 1) of EN3835-201 study in CR-PCSS Scale is 5-levels, 0=None to 4=Severe
Interventions
- BIOLOGICAL Previously Treated with EN3835
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2019-03-28 |
| Est. Completion | 2019-06-25 |
What the finished NCT03893890 record still lists
NCT03893890 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 8 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Previously Treated with EN3835 is the first listed.
NCT03893890 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03893890 about?
NCT03893890 is a clinical study titled "Durability and Safety of EN3835 in the Treatment of EFP (Cellulite) in Women". This is a Phase 2b, rollover, long-term study to evaluate the safety and duration of efficacy of EN3835 in the treatment of women with EFP. Subjects who participated in and completed studies EN3835-201 and EN3835-202 and had composite improvement of at least 2 levels on both the CR-PCSS and PR-PCSS ...
What is the current status of trial NCT03893890?
This trial is currently completed. The enrollment target is 8 participants. The study started on 2019-03-28. Estimated completion is 2019-06-25.
What interventions are being tested in trial NCT03893890?
The interventions under investigation include: Previously Treated with EN3835 (BIOLOGICAL).
Who is sponsoring clinical trial NCT03893890?
This trial is sponsored by Endo USA Inc., a Keenova Therapeutics Company, which has 61 total clinical trials registered on ClinicalTrials.gov.
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