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NCT03893890
Durability and Safety of EN3835 in the Treatment of EFP (Cellulite) in Women
trial testing Previously Treated with EN3835 in Edematous Fibrosclerotic Panniculopathy in 8 participants. Completed in 25 June 2019.
25 June 2019
Quick facts
| Lead sponsor | Endo Pharmaceuticals |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 8 |
| Start date | 28 March 2019 |
| Primary completion | 25 June 2019 |
| Estimated completion | 25 June 2019 |
| Sites | 5 locations across United States |
Drugs / interventions tested
- Previously Treated with EN3835 — full drug profile →
Conditions studied
- Edematous Fibrosclerotic Panniculopathy — all drugs for Edematous Fibrosclerotic Panniculopathy →
Sponsor
Endo Pharmaceuticals — full company profile →
Who can join
18 and older, female only, with Edematous Fibrosclerotic Panniculopathy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03893890
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Previously Treated with EN3835
Trials testing the same drug.
- NCT04381117 — Long-term Durability Study of Collagenase Clostridium Histolyticum (CCH) · completed
Other Endo Pharmaceuticals trials
Trials by the same sponsor.
- NCT06169319 — A Study to Assess Collagenase Clostridium Histolyticum (CCH) in the Treatment of Plantar Fasciitis (PFA) · Phase 2 · completed
- NCT05873595 — Real-World Data Study to Understand Effectiveness of Treatments in Peyronie's Disease · terminated
- NCT05877066 — Real-World Data Study to Understand Participant Treatment Outcomes for Dupuytren's Contracture · terminated
- NCT05419505 — Study of Different Interventions to Reduce Bruising Following CCH-Aaes Treatment for Cellulite of the Buttocks · Phase 2 · completed
- NCT05254457 — Long-Term Safety, Efficacy, and Durability of EN3835 in the Treatment and Retreatment of Plantar Fibromatosis · Phase 3 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03893890 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Endo Pharmaceuticals
- Last refreshed: 19 July 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03893890.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing