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NCT04605107
Biosimilarity Study of IM Injection of Human Chorionic Gonadotrophin After Parenteral Administration of Treatment A TEST Product Epifasi 5000 I.U. Ampoules (EIPICO PHARMA, EGYPT) and Treatment B REFERENCE Product Pregnyl 5000 I.U. Ampoules (Baxter Pharmaceutical Solutions for Organon, USA).
Phase 4 trial testing Epifasi: Human chorionic gonadotrophin in Infertility, Female in 60 participants. Completed in 8 March 2015.
8 January 2015
Quick facts
| Lead sponsor | Genuine Research Center, Egypt |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | health services research |
| Enrollment | 60 |
| Start date | 30 August 2013 |
| Primary completion | 8 January 2015 |
| Estimated completion | 8 March 2015 |
| Sites | 1 location across Egypt |
Drugs / interventions tested
- Epifasi: Human chorionic gonadotrophin — full drug profile →
- Pregnyl: Human chorionic gonadotrophin — full drug profile →
Conditions studied
- Infertility, Female — all drugs for Infertility, Female →
Sponsor
Genuine Research Center, Egypt — full company profile →
Who can join
Adults 18 to 40, female only, with Infertility, Female. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Comparative randomized, single dose, parallel, triple-blinded study in infertile females to evaluate biosimilarity of IM Injection of Human Chorionic Gonadotrophin (HCG) after Parenteral administration of Treatment A TEST Product Epifasi 5000 I.U. Ampoules (EIPICO PHARMA, EGYPT) and Treatment B REFERENCE Product Pregnyl 5000 I.U. Ampoules (Baxter Pharmaceutical Solutions for Organon, USA)
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 NCT04605107
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Other Genuine Research Center, Egypt trials
Trials by the same sponsor.
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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 NCT04605107 (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 Genuine Research Center, Egypt
- Last refreshed: 27 October 2020
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/NCT04605107.
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