Prevention of HEMOrhagic risk in upper MYOmeCTomy by use of Misoprostol.

2024-513617-13-00 Protocol RBHP 2024 GREMEAU Therapeutic exploratory (Phase II) Ongoing, recruiting

Start 14 Apr 2025 · Status Ongoing, recruiting · 1 EU/EEA countries · 1 sites · Protocol RBHP 2024 GREMEAU

Overview

Sponsor-declared trial summary

Phase Therapeutic exploratory (Phase II)
Status Ongoing, recruiting
Participants planned 80
Countries 1
Sites 1

fibroma

Evaluation of intraoperative blood loss during myomectomies with OTAU after administration of misoprostol 400μg PO (experimental group) versus placebo (control group) regardless of the type of surgery.

Key facts

Sponsor
University Hospital Of Clermont-Ferrand
Participant type
Patients
Age range
18-64 years
Gender
Female
Therapeutic area
Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13], Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutics [E02]
Trial duration
14 Apr 2025 → ongoing
Decision date (initial)
2024-12-19
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
No

External identifiers

EU CT number
2024-513617-13-00
ClinicalTrials.gov
NCT06882824

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Efficacy

Evaluation of intraoperative blood loss during myomectomies with OTAU after administration of misoprostol 400μg PO (experimental group) versus placebo (control group) regardless of the type of surgery.

Secondary objectives 19

  1. Compare between the experimental group and the control group: - a) The difference in haemoglobin between d-1 and d1 and the crude level on d1
  2. Compare between the experimental group and the control group: - b) Patient characteristics
  3. Compare between the experimental group and the control group: - c) Characteristics of fibroids
  4. Compare between the experimental group and the control group: - d) The time between taking the tablet and the incision
  5. Compare between the experimental group and the control group: - e) The total operating time
  6. Compare between the experimental group and the control group: - (f) Transfusion rate
  7. Compare between the experimental group and the control group: - g) Immediate postoperative complications
  8. Compare between the experimental group and the control group: - h) Pain assessments at different times: VAS at h+2, h+6 J1 M1
  9. Compare between the experimental group and the control group: - i) Length of hospital stay in days
  10. Compare the difference in haemoglobin between d-1 and d1 and the crude level on d1 according to the surgical technique (laparoscopy and laparotomy)
  11. Compare the patient characteristics according to the surgical technique (laparoscopy and laparotomy)
  12. Compare the characteristics of fibroids according to the surgical technique (laparoscopy and laparotomy) Characteristics of fibroids
  13. Compare the time between taking the tablet and the incision according to the surgical technique (laparoscopy and laparotomy)
  14. Compare the total operating time according to the surgical technique (laparoscopy and laparotomy)
  15. Compare transfusion rate according to the surgical technique (laparoscopy and laparotomy)
  16. Compare immediate postoperative complications according to the surgical technique (laparoscopy and laparotomy)
  17. Compare pain assessments at different times: VAS at h+2, h+6 J1 M1 according to the surgical technique (laparoscopy and laparotomy)
  18. Compare length of hospital stay in days according to the surgical technique (laparoscopy and laparotomy)
  19. Evaluation of intraoperative blood loss during myomectomies with OTAU after administration of misoprostol 400μg PO (experimental group) versus placebo (control group) regardless of the type of surgery, then in laparoscopy and laparotomy.

Conditions and MedDRA coding

fibroma

VersionLevelCodeTermSystem organ class
21.1 LLT 10081129 Uterine fibroma 10029104

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

  1. Patient aged 18 to 43
  2. Symptomatic myomas (hemorrhages, pain or infertility)
  3. Indication for myomectomy by laparoscopy Fibroid ≤ 10cm or number ≤ 4 fibroids
  4. Indication for myomectomy by laparotomy Fibroid > 10cm, Number > 4 fibroids
  5. OTAU possible intraoperatively (Clip on uterine artery and Placement of a turnstile)

Exclusion criteria 8

  1. History of major uterine surgery or myomectomy (excluding myomectomy by hysteroscopy)
  2. Allergy to misoprostol
  3. Patient on aspirin or anticoagulant
  4. Patients with a hemostasis disorder
  5. Patient with hypersensitivity to misoprostol and/or other prostaglandins or to any of the excipients of the product
  6. Malnourished patients
  7. Patients with hepatic or renal impairment
  8. Pregnancy, suspected ectopic pregnancy and breastfeeding women.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. Intraoperative blood loss measured in mL (volume in the suction and blood volumes in the compresses after weighing) according to the randomization group.

Secondary endpoints 19

  1. Depending on the randomization group, compare the difference in hemoglobin pre- and post-operatively then at 1 month and hemoglobin level
  2. Depending on the randomization group, compare: Demographic characteristics of patients and fibroids: BMI, Age, Gesture, Parity, Ethnicity, Tobacco, Taking pre-operative hormonal treatment, Type of treatment.
  3. Depending on the randomization group, compare: Characteristics of myomas: Types of myomas (FIGO), Size of myomas, Number of myomas.
  4. Depending on the randomization group, compare the duration between taking the tablet and anesthetic induction then the incision
  5. Depending on the randomization group, compare the duration between incision or pneumoperitoneum and closure
  6. Depending on the randomization group, compare the accounting for the number of RGCs transfused.
  7. Depending on the randomization group, compare the collection of early postoperative complications.
  8. Depending on the randomization group, compare : EVA at H+2, H+6 D1 M1.
  9. Depending on the randomization group, compare : Length of hospitalization in days.
  10. Depending on the type of surgery compare the difference in hemoglobin pre- and post-operatively then at 1 month and hemoglobin level
  11. Depending on the type of surgery compare the demographic characteristics of patients and fibroids: BMI, Age, Gesture, Parity, Ethnicity, Tobacco, Taking pre-operative hormonal treatment, Type of treatment.
  12. Depending on the type of surgery compare the characteristics of myomas: Types of myomas (FIGO), Size of myomas, Number of myomas.
  13. Depending on the type of surgery compare the duration between taking the tablet and anesthetic induction then the incision
  14. Depending on the type of surgery compare the duration between incision or pneumoperitoneum and closure.
  15. Depending on the type of surgery compare the accounting for the number of RGCs transfused.
  16. Depending on the type of surgery compare the collection of early postoperative complications.
  17. Depending on the type of surgery compare EVA at H+2, H+6 D1 M1
  18. Depending on the type of surgery compare the length of hospitalization in days.
  19. Intraoperative blood loss measured in mL (volume in aspiration and blood volumes in compresses after weighing) according to the randomization group and surgical technique.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

MisoOne 400 mikrogramų tabletės

PRD10110585 · Product

Active substance
Misoprostol
Pharmaceutical form
TABLET
Route of administration
ORAL
Max daily dose
400 Aµg microgram(s)
Max total dose
400 Aµg microgram(s)
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
G02AD06 — -
Marketing authorisation
LT/1/22/5077/003
MA holder
EXELGYN SA
MA country
Lithuania
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Placebo 1

Placebo

SUB21402 · Substance

Active substance
Placebo
Pharmaceutical form
COATED TABLET
Route of administration
ORAL
Max daily dose
0 mg milligram(s)
Max total dose
0 mg milligram(s)
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

University Hospital Of Clermont-Ferrand

13 Total trials 9 Recruiting 1 Ended
Academic / Non-commercial
Sponsor organisation
University Hospital Of Clermont-Ferrand
Address
58 Rue Montalembert
City
Clermont Ferrand Cedex 1
Postcode
63003
Country
France

Scientific contact point

Organisation
University Hospital Of Clermont-Ferrand
Contact name
Lise Laclautre

Public contact point

Organisation
University Hospital Of Clermont-Ferrand
Contact name
Lise Laclautre

Locations

1 EU/EEA country · 1 investigational sites

By country

CountryMS statusPlanned subjectsSites
France Ongoing, recruiting 80 1
Rest of world — 0 —

Investigational sites

France

1 site · Ongoing, recruiting
University Hospital Of Clermont-Ferrand
Gynecologie Obstétrique, 1 Place Lucie Et Raymond Aubrac, 63100, Clermont-Ferrand

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
France 2025-04-14 2025-06-16

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 13 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) D1_Protocole_2024-513617-13-00 3
Protocol (for publication) D1_Protocole_2024-513617-13-00_suivi_modif 3
Protocol (for publication) D1_Signature protocole_2024513617-13-00 3
Recruitment arrangements (for publication) K1_Recruitment-arrangements 1
Subject information and informed consent form (for publication) L1_SIS-and-ICF patient Hemomyoc 2
Subject information and informed consent form (for publication) L1_SIS-and-ICF_patient Hemomyoc 1
Subject information and informed consent form (for publication) L1_SIS-and-ICF_patient_Hemomyoc 3
Subject information and informed consent form (for publication) L1_SIS-and-ICF_patient_Hemomyoc_suivi modif 3
Subject information and informed consent form (for publication) L1_SIS-and-ICF_patient_Hemomyoc_suivi_modif 2
Summary of Product Characteristics (SmPC) (for publication) E1_IB_MisoOne_utilisation_hors_AMM 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC_MisoOne 2
Synopsis of the protocol (for publication) D1_Protocole_synopsis FR_2024-513617-13-00_clean 4
Synopsis of the protocol (for publication) D1_Protocole_synopsis FR_2024-513617-13-00_suivi_modif 4

Application history

2 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2024-09-24 France Acceptable
2024-12-19
 2024-12-19
2 SUBSTANTIAL MODIFICATION SM-2 2025-04-24 France Acceptable
2025-06-05
 2025-06-05