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NCT04500028
Vaginal Isonicotinic Acid Hydrazide Administration Prior to Insertion Levonorgestrel-releasing Intrauterine System
Phase 4 trial testing INH in IUCD Complication in 220 participants. Completed in 1 December 2021.
31 October 2021
Quick facts
| Lead sponsor | Aswan University Hospital |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | prevention |
| Enrollment | 220 |
| Start date | 1 August 2020 |
| Primary completion | 31 October 2021 |
| Estimated completion | 1 December 2021 |
| Sites | 1 location across Egypt |
Drugs / interventions tested
- INH — full drug profile →
- Placebo Comparator
Conditions studied
- IUCD Complication — all drugs for IUCD Complication →
Sponsor
Aswan University Hospital
Who can join
Adults 18 to 45, female only, with IUCD Complication. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
To investigate whether vaginal isonicotinic acid hydrazide (INH) administered before the levonorgestrel-releasing intrauterine system(IUs) insertion reduces failed insertions, insertion-related complications, and pain in Women With no Previous Vaginal Delivery.
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 NCT04500028
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of INH
Trials testing the same drug.
- NCT04500496 — Vaginal Dinoprostone Versus Isonicotinic Acid Hydrazide Prior to Diagnostic Office Hysteroscopy · NA · unknown
- NCT04500015 — Vaginal Isonicotinic Acid Hydrazide Administration Prior to Intrauterine Device Insertion · Phase 4 · completed
- NCT04500522 — Vaginal Isonicotinic Acid Hydrazide Prior to Diagnostic Office Hysteroscopy in Primarily Infertile Patients · Phase 4 · completed
- NCT04499989 — Vaginal Isonicotinic Acid Hydrazide (INH) Administration Prior to T380A Intrauterine Device Insertion · Phase 4 · completed
Other Aswan University Hospital trials
Trials by the same sponsor.
- NCT06491394 — Lactoferrin Effect on Kidney and Heart of Rhabdomyolysis Rats · Phase 4 · completed
- NCT06211088 — Famotidine Versus Placebo in Emergency Pediatric Surgery As a Risk to Postoperative Nausea and Vomiting · NA · completed
- NCT06583590 — Evaluation of Efficacy of Botulinum Toxin A Plus Oral Tadalafil 5 mg in Diabetic Men With Erectile Dysfunction · Phase 2, PHASE3 · recruiting
- NCT06537323 — Femoral Nerve Block, Periarticular Nerve Group (PENG) Block, and Preoperative IV Fentanyl · NA · recruiting
- NCT06535256 — Compare Intraperitoneal Instillation of Bupivacaine+dexmedetomidine Versus Bupivacaine+dexamethasone on Postoperative Pa · NA · 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 NCT04500028 (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 Aswan University Hospital
- Last refreshed: 13 May 2022
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/NCT04500028.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing