Cervical prep strategies before office hysteroscopy in postmenopausal women
Official title: A Four-Arm Prospective Randomized Controlled Trial Comparing Oral Misoprostol, Two Vaginal Estrogen Regimens, and No Cervical Preparation Before Office Hysteroscopy in Postmenopausal Women
Run by Faculty of Medicine of Tunis · NCT07697781 · Data updated 2026-11-12
This trial tests four cervical preparation options to see which helps complete office hysteroscopy best and which causes less pain for postmenopausal women evaluated for intrauterine pathology.
Quick facts
| Study type | Interventional |
|---|---|
| Sex | Women only |
| Enrollment | 120 (estimated) |
| Sponsor | Faculty of Medicine of Tunis Academic / other |
| Locations | 1 site (Tunis, Tunis Governorate) |
| Status | Recruiting |
| Started | January 2, 2026 |
| Main results expected | July 30, 2026 |
| Study ends | October 30, 2026 |
| Registry record updated | October 16, 2026 |
| Trial ID | NCT07697781 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Postmenopausal women scheduled for office hysteroscopy to evaluate suspected intrauterine pathology who can consent and have no contraindications to misoprostol or vaginal estrogen.
✕Probably not a fit
Participants with insufficient visualization or adverse reactions to the cervical preparations may not experience benefits from the assigned protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
In this randomized study, postmenopausal women scheduled for office hysteroscopy will be assigned to one of four cervical preparation protocols: 14-day vaginal estrogen, 7-day vaginal estrogen, oral misoprostol, or no preparation. Procedures will use a vaginoscopic, no-anesthesia approach, with pain measured during the procedure and data collected on success, duration, and perioperative complications. The aim is to determine which approach improves complete visualization and minimizes discomfort. The trial is conducted at the Maternity and Neonatology Center of Tunis under the Faculty of Medicine of Tunis. Eligible participants are postmenopausal women without contraindications who provide informed consent.
Why it matters
Potential benefit: If successful, the study could identify a cervical prep that increases the likelihood of a complete, painless office hysteroscopy in postmenopausal women.
How similar studies have gone: Prior work in this area suggests that cervical preparation can influence procedural success and pain, but direct comparisons of these four strategies in postmenopausal office hysteroscopy are not well established.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women with postmenopausal status. * Scheduled for office hysteroscopy for the evaluation of suspected intrauterine pathology. * Able to understand the study procedures and provide written informed consent. Exclusion Criteria: * Known or suspected hormone-dependent malignancy (e.g., breast or endometrial cancer). * Active genital tract infection. * Contraindication or known hypersensitivity to misoprostol or vaginal estrogen. * Refusal to undergo office hysteroscopy without anesthesia. * Active uterine bleeding preventing adequate hysteroscopic visualization on the day of the procedure.
Where it's running
-
Maternity and neonatology center of Tunis
Tunis, Tunis Governorate, Tunisia Recruiting
Study contacts
- Study coordinator: Mohammed Amine Hannachi, Assistant professor
- Email: medaminehannachi3@gmail.com
- Phone: +21699696332
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.