Postmenopausal WomenNCT07697781
Office Hysteroscopy in Postmenopausal Women: A Randomized Trial of Cervical Preparation Strategies
A study testing No Cervical Preparation, Misoprostol ( Cytotec) 200 microgram a tablet and Vaginal Estrogen (7-Day Regimen) in people with Postmenopausal Women and Intrauterine Diseases, run by Faculty of Medicine of Tunis at 1 site in Tunisia.
Trial summary
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Postmenopausal Women, Intrauterine Diseases, Endometrial Pathology
- What is being tested?
- No Cervical Preparation, Misoprostol ( Cytotec) 200 microgram a tablet and Vaginal Estrogen (7-Day Regimen)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTunisia
- Study dates
- 2 Jan 2026to 30 Oct 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Tunisia1 site, 1 recruiting
- Recruiting
Maternity and neonatology center of Tunis
Tunis, Tunis Governorate, 1007
Mohammed Amine Hannachi, 99696332, medaminehannachi3@gmail.com
Khaled Neji, Professor, +21651352742, DRKHALEDNEJI21@GMAIL.COM
About this study
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
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:
Read more
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.
- Conditions
- Postmenopausal Women, Intrauterine Diseases, Endometrial Pathology, Postmenopausal Bleeding, Abnormal Uterine Bleeding (AUB)
- Being tested
- No Cervical Preparation, Misoprostol ( Cytotec) 200 microgram a tablet, Vaginal Estrogen (7-Day Regimen), Vaginal Estrogen (14-Day Regimen)
- Keywords
- Postmenopausal women, Postmenopausal bleeding, Office hysteroscopy, Cervical preparation, Vaginal estrogen, Oral misoprostol, Visual Analog Scale, Vaginoscopy, No touch approach
- Medical subject headings
- Metrorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Cervical PreparationOther
No pharmacological cervical preparation is administered before office hysteroscopy.
Misoprostol ( Cytotec) 200 microgram a tabletDrug
Misoprostol 200 µg administered sublingually 2 hours before office hysteroscopy for cervical ripening.
Vaginal Estrogen (7-Day Regimen)Drug
Vaginal estrogen 20 µg administered once daily for 7 consecutive days before office hysteroscopy to facilitate cervical ripening.
Vaginal Estrogen (14-Day Regimen)Drug
Vaginal estrogen 20 µg administered once daily for 14 consecutive days before office hysteroscopy to facilitate cervical ripening.
| Study group | Role | What they receive |
|---|---|---|
| No Cervical Preparation | Other | Participants undergo office hysteroscopy without any cervical preparation. Receives: Other: No Cervical Preparation |
| Oral Misoprostol | Experimental | Participants receive 200 µg of misoprostol administered sublingually 2 hours before office hysteroscopy. Receives: Drug: Misoprostol ( Cytotec) 200 microgram a tablet |
| 7-Day Vaginal Estrogen | Experimental | Participants receive 20 µg vaginal estrogen once daily for 7 consecutive days before office hysteroscopy. Receives: Drug: Vaginal Estrogen (7-Day Regimen) |
| 14-Day Vaginal Estrogen | Experimental | Participants receive 20 µg vaginal estrogen once daily for 14 consecutive days before office hysteroscopy. Receives: Drug: Vaginal Estrogen (14-Day Regimen) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful office hysteroscopy
A complete hysteroscopic examination of the uterine cavity.
Measured: 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.
Measured: During the office hysteroscopy procedure. 5 minutes after the procedure. 10 minutes after the procedure.
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: From date of randomization up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study start2 Jan 2026
- Primary completion30 Jul 2026
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Postmenopausal WomenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Faculty of Medicine of Tunis
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Amine HANNACHI, Faculty of Medicine of Tunis
- Investigators
- KHALED M NEJI, Study chair, Maternity and neonatology center of Tunis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07697781
- Sponsor's protocol ID
- CERV-PREP-MENO-HSC
- Status last verified
- Oct 2026
- First submitted
- 6 Jul 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Samy A, Nabil H, Abdelhakim AM, Mahy ME, Abdel-Latif AA, Metwally AA. Pain management during diagnostic office hysteroscopy in postmenopausal women: a randomized study. Climacteric. 2020 Aug;23(4):397-403. doi: 10.1080/13697137.2020.1742685. Epub 2020 Apr 17.
PubMed 32299254Sauvan M, Pourcelot AG, Fournet S, Fernandez H, Capmas P. Office hysteroscopy for postmenopausal women: Feasibility and correlation with transvaginal ultrasound. J Gynecol Obstet Hum Reprod. 2018 Dec;47(10):505-510. doi: 10.1016/j.jogoh.2018.08.018. Epub 2018 Sep 5.
PubMed 30193870Wood MA, Kerrigan KL, Burns MK, Glenn TL, Ludwin A, Christianson MS, Bhagavath B, Lindheim SR. Overcoming the Challenging Cervix: Identification and Techniques to Access the Uterine Cavity. Obstet Gynecol Surv. 2018 Nov;73(11):641-649. doi: 10.1097/OGX.0000000000000614.
PubMed 30468239Sorbi F, Fambrini M, Saso S, Lucenteforte E, Lisi F, Piciocchi L, Cioni R, Petraglia F. Office hysteroscopy in pre- and post-menopausal women: a predictive model. Gynecol Endocrinol. 2021 Mar;37(3):206-210. doi: 10.1080/09513590.2020.1864316. Epub 2020 Dec 26.
PubMed 33356672Giorda G, Scarabelli C, Franceschi S, Campagnutta E. Feasibility and pain control in outpatient hysteroscopy in postmenopausal women: a randomized trial. Acta Obstet Gynecol Scand. 2000 Jul;79(7):593-7.
PubMed 10929961Gorodeski GI. Effects of menopause and estrogen on cervical epithelial permeability. J Clin Endocrinol Metab. 2000 Jul;85(7):2584-95. doi: 10.1210/jcem.85.7.6671.
PubMed 10902812Cooper NA, Smith P, Khan KS, Clark TJ. Does cervical preparation before outpatient hysteroscopy reduce women's pain experience? A systematic review. BJOG. 2011 Oct;118(11):1292-301. doi: 10.1111/j.1471-0528.2011.03046.x. Epub 2011 Jul 29.
PubMed 21797959