An interventional study of No Cervical Preparation and Misoprostol ( Cytotec) 200 microgram a tablet in Postmenopausal Women, Intrauterine Diseases and Endometrial Pathology, sponsored by Faculty of Medicine of Tunis. Recruiting at 1 site in Tunisia. Open to female participants. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by Faculty of Medicine of Tunis · Not applicable, Interventional, and Treatment
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.
153 studies on the registry are indexed under Metrorrhagia; 35 are open to participants now.
This study's planned enrollment of 120 is above the median of 100 across 115 interventional studies indexed under Metrorrhagia.
Browse Metrorrhagia studies →Faculty of Medicine of Tunis is the lead sponsor of 5 studies on the registry; 4 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants undergo office hysteroscopy without any cervical preparation.
Other: No Cervical Preparation
Participants receive 200 µg of misoprostol administered sublingually 2 hours before office hysteroscopy.
Drug: Misoprostol ( Cytotec) 200 microgram a tablet
Participants receive 20 µg vaginal estrogen once daily for 7 consecutive days before office hysteroscopy.
Drug: Vaginal Estrogen (7-Day Regimen)
Participants receive 20 µg vaginal estrogen once daily for 14 consecutive days before office hysteroscopy.
Drug: Vaginal Estrogen (14-Day Regimen)
No pharmacological cervical preparation is administered before office hysteroscopy.
Misoprostol 200 µg administered sublingually 2 hours before office hysteroscopy for cervical ripening.
Vaginal estrogen 20 µg administered once daily for 7 consecutive days before office hysteroscopy to facilitate cervical ripening.
Vaginal estrogen 20 µg administered once daily for 14 consecutive days before office hysteroscopy to facilitate cervical ripening.
Successful office hysteroscopy
A complete hysteroscopic examination of the uterine cavity.
Time frame: During the office hysteroscopy procedure
Pain during office hysteroscopy
Patient-reported pain assessed using a 10-cm Visual Analog Scale (VAS) during hysteroscopy, 5 minutes after the procedure and 10 minutes after the procedure. 0 is assigned to no pain \& 10 is assigned to the most pain imaginable.
Time frame: During the office hysteroscopy procedure. 5 minutes after the procedure. 10 minutes after the procedure.
Procedure-related complications
Incidence of complications occurring during or immediately after office hysteroscopy, including cervical laceration, uterine perforation, excessive bleeding, vasovagal reaction, or failure requiring conversion to hysteroscopy under anesthesia.
Time frame: During the procedure and up to 24 hours after office hysteroscopy
Patient satisfaction with cervical preparation
Patient satisfaction with the assigned cervical preparation protocol, assessed using a Patient Satisfaction Percentage Scale, a self-reported scale ranging from 0% to 100%, where 0% indicates not satisfied at all and 100% indicates completely satisfied. Higher scores indicate greater patient satisfaction.
Time frame: Immediately after the procedure
Adverse effects of cervical preparation
Incidence of adverse effects related to cervical preparation, including abdominal pain, uterine cramping, vaginal bleeding, nausea, vomiting, diarrhea, headache, dizziness, or local vaginal irritation.
Time frame: From date of randomization up to 14 days
Plan to share: Undecided
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drugs tested here: Misoprostol · Estrogens
Faculty of Medicine of Tunis