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Office Hysteroscopy in Postmenopausal Women: A Randomized Trial of Cervical Preparation Strategies

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Study completion pushed from Aug 20, 2026 to Sep 30, 2026v2
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this randomized controlled trial is to evaluate the effectiveness of different cervical preparation strategies before office hysteroscopy in postmenopausal women undergoing evaluation for intrauterine pathology. The main questions to answer are: Does cervical preparation improve the success rate of complete office hysteroscopy in postmenopausal women? Which cervical preparation strategy provides better patient tolerance, as assessed by pain intensity during the procedure? Researchers will compare four cervical preparation protocols (14-day vaginal estrogen, 7-day vaginal estrogen, oral misoprostol, and no cervical preparation) to determine their effects on procedural success, pain, procedure duration, and perioperative complications. Participants will be randomly assigned to one of the four cervical preparation protocols. They will undergo office hysteroscopy using a vaginoscopic ("no touch") approach without anesthesia. Then, they will have pain assessed using a visual analog scale (VAS) during the procedure. Finally, these informations will be collected: procedural success, procedure duration, bleeding, and perioperative complications.
Trial Details
NCT Number NCT07697781
Lead Sponsor Faculty of Medicine of Tunis
Conditions
(from sponsor)
Postmenopausal Women, Intrauterine Diseases, Endometrial Pathology, Postmenopausal Bleeding, Abnormal Uterine Bleeding (AUB)
Related terms Metrorrhagia
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov