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NCT05205317
Comparison of the Therapeutic Effects of VR and VR + Metformin in the Treatment of Cesarean Section Scar Defect
NA trial testing Metformin Hydrochloride Sustained-release Tablets in Defect in 100 participants. Currently enrolling.
31 December 2024
Quick facts
| Lead sponsor | Xinhua Hospital, Shanghai Jiao Tong University School of Medicine |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 100 |
| Start date | 15 April 2023 |
| Primary completion | 31 December 2024 |
| Estimated completion | 30 June 2025 |
| Sites | 1 location across China |
Drugs / interventions tested
- Metformin Hydrochloride Sustained-release Tablets — full drug profile →
- Vaginal repair
Conditions studied
- Defect — all drugs for Defect →
Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Who can join
Adults 18 to 40, female only, with Defect. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Cesarean section scar defect (CSD) is a novel recognized cause of postmenstrual abnormal uterine bleeding in women. No clinical guidelines have been issued for the management of CSD. The investigators have previously demonstrated that vaginal repair of CSD was an relative effective treatment of CSD. However, only 28.2% of the CSD patients normalized to less than 7 days of menstruation, whereas 51.2% of women had 7 to 10 days of menstruation at 6 months post vaginal repair. The previous research suggested that the occurrence of CSD may be related to the aging phenotype of the myometrium. Metformin, as a classic diabetes treatment drug, has an important position in anti-aging therapy. Therefore, the randomized study was designed to evaluate whether the application of metformin in combination with vaginal repair could achieve better clinical effects than those achieved by vaginal CSD repair alone.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05205317
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Xinhua Hospital, Shanghai Jiao Tong University School of Medicine trials
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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 NCT05205317 (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 Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Last refreshed: 2 October 2024
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/NCT05205317.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing