Last reviewed · How we verify
NCT06882824: HEMOMYOC
Prevention of HEMOrhagic Risk in Upper MYOmeCTomy by Use of Misoprostol.
NA trial testing myomectomy with placebo in Myoma;Uterus in 80 participants. Currently enrolling.
17 April 2027
Quick facts
| Lead sponsor | University Hospital, Clermont-Ferrand |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | prevention |
| Enrollment | 80 |
| Start date | 12 March 2025 |
| Primary completion | 17 April 2027 |
| Estimated completion | 17 April 2028 |
| Sites | 1 location across France |
Drugs / interventions tested
- myomectomy with placebo
- myomectomy with misoprostol
Conditions studied
- Myoma;Uterus — all drugs for Myoma;Uterus →
- Myomectomy; Surgical Blood Loss — all drugs for Myomectomy; Surgical Blood Loss →
Sponsor
University Hospital, Clermont-Ferrand
Who can join
Adults 18 to 43, female only, with Myoma;Uterus or Myomectomy; Surgical Blood Loss. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
In France, uterine fibroids or leiomyomas are the most common benign tumour in women of childbearing age. In 30% of cases, fibroids are symptomatic (menorrhagia, anaemia, pain), in which case surgical management is indicated. This is known as myomectomy, and can be performed by hysteroscopy, laparoscopy (laparoscopy) or laparotomy, depending on the number, size and position of the fibroids. Intraoperative bleeding is the main surgical difficulty. For this reason, a number of studies have focused on ways of minimizing the risk of bleeding. A good surgical indication, prevention of anaemia (iron deficiency) and transient occlusion of the uterine arteries during surgery help to reduce this risk. There are also drugs available to reduce intraoperative bleeding, but few studies have been carried out to assess their real effectiveness. One such product is Misoprostol, commonly used in gynecology. Its muscle-contracting properties suggest that it could have a beneficial effect on bleeding during surgery. What's more, this treatment has been used for many years and is reputed to be very well tolerated. The most frequent side effects are digestive, with a risk of abdominal pain in the form of cramps, nausea or vomiting. The investigators therefore decided to set up the HEMOMYOC study to demonstrate a significant reduction in bleeding during laparotomy or laparoscopic myomectomy after taking oral misoprostol in combination with transient occlusion of the uterine arteries, compared with placebo. It would seem that the ease of use and good tolerance of misoprostol, in combination with transient occlusion of the uterine arteries, could be of real benefit in preventing intraoperative morbidity in myomectomies, whatever the surgical approach. To date, no studies have been carried out in this area.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06882824
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Myoma;Uterus
Currently open trials in the same condition.
- NCT07526311 — Reducing Blood Loss During Myomectomy:Uterine Artery Ligation Vs Pericervical Tourniquet · NA · recruiting
- NCT07390864 — Ergometrine Versus Carbetocin to Decrease Blood Loss in Myomectomy · NA · recruiting
- NCT04990076 — Ultrasound Evaluation of the Myometrium Using the MUSA Terminology Comparison With Histology · recruiting
- NCT03880435 — HYALOBARRIER® GEL ENDO Versus no HYALOBARRIER® GEL ENDO Following Operative Hysteroscopy for Improving Reproductive Outc · NA · active not recruiting
Other University Hospital, Clermont-Ferrand trials
Trials by the same sponsor.
- NCT07179276 — Veno-arterial Carbon Dioxide Partial Pressure Difference (CO2gap) for Early Resuscitation of Septic Shock · NA · recruiting
- NCT07476768 — PAINDYS_Characterizing Pain in Fibrous Dysplasia of Bone/McCune-Albright Syndrome: an Exploratory Pilot Study · NA · not yet recruiting
- NCT07439146 — Risk of Pneumonia in Intubated Patients in Emergency Situations · not yet recruiting
- NCT07427537 — Exploration of Circulating microRNAs as Biomarkers of Chemo-induced Peripheral Neuropathy: a Study in Cancer Patients · NA · recruiting
- NCT07330856 — Evaluation of Treatments for Dry or Productive Cough · Phase 4 · not yet recruiting
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 NCT06882824 (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 University Hospital, Clermont-Ferrand
- Last refreshed: 24 September 2025
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/NCT06882824.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing