Last reviewed · How we verify
NCT02571101
A Prospective, Randomized, Double-blinded, Active-control, 3-Treatment Arm, Parallel, Multi-center, Phase 2 Trial to Evaluate Safety and Efficacy With CDFR0812-15/25mg and CDFR0812-15/50mg Compared to Clomipramine HCl 15mg in Male Patients Diagnosed With Premature Ejaculation
Phase 2 trial testing CDFR0812-15/25mg in Premature Ejaculation in 297 participants. Status unknown.
1 May 2016
Quick facts
| Lead sponsor | CTC Bio, Inc. |
|---|---|
| Phase | Phase 2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 297 |
| Start date | 1 November 2015 |
| Primary completion | 1 May 2016 |
| Estimated completion | 1 June 2016 |
| Sites | 9 locations across South Korea |
Drugs / interventions tested
- CDFR0812-15/25mg — full drug profile →
- CDFR0812-15/50mg — full drug profile →
- Condencia — full drug profile →
- CDFR0812-Placebo — full drug profile →
- Condencia-Placebo — full drug profile →
Conditions studied
- Premature Ejaculation — all drugs for Premature Ejaculation →
Sponsor
CTC Bio, Inc. — full company profile →
Who can join
Adults 19 to 65, male only, with Premature Ejaculation. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
The fold change of IELT
Time frame: From 4 weeks to 8 weeks after dosing
IELT(Intravaginal Ejaculation Latency Time), which is to be reported through patient diary
Sponsor's own description
The purpose of this study is to evaluate the safety and efficacy of on-demand therapy with CDFR0812-15/25mg and CDFR0812-15/50mg compared to on-demand therapy with single-drug administration of Clomipramine HCl 15mg in Korean Male Patients Diagnosed with Premature Ejaculation
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT02571101
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Premature Ejaculation
Currently open trials in the same condition.
- NCT07442396 — The Effectiveness of Exercise in the Treatment of Erectile Dysfunction and Premature Ejaculation · NA · recruiting
- NCT07434271 — Study to Evaluate the Potential Effects of KH-001 on Intravaginal Ejaculatory Latency Time (IELT), Patient-Reported Outc · Phase 2 · recruiting
- NCT06570135 — Brain Activity During Sexual Behavior in Patients With Primary Premature Ejaculation a Clinical Trial · NA · recruiting
- NCT06851598 — Safety and Efficacy of Botulinum Toxin-A Injection Into Ischiocavernosus Muscle for Premature Ejaculation · Phase 2, PHASE3 · active not recruiting
- NCT06605469 — Ejaculatory and Orgasmic Dysfunction Registry · recruiting
Other CTC Bio, Inc. trials
Trials by the same sponsor.
- NCT04631874 — A Clinical Trial to Compare Pharmacokinetics of the "CDFF0318" and "Champix Tab. 1mg" · Phase 1 · 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 NCT02571101 (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 CTC Bio, Inc.
- Last refreshed: 16 December 2015
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/NCT02571101.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing