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NCT Number: NCT07697781

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

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.

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Key information

Conditions

Postmenopausal Women Abnormal Uterine Bleeding (AUB) Endometrial Pathology Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Hemorrhage Intrauterine Diseases Metrorrhagia Pathologic Processes Pathological Conditions, Signs and Symptoms Postmenopausal Bleeding Urogenital Diseases Uterine Diseases Uterine Hemorrhage

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No Cervical Preparation

Other

No pharmacological cervical preparation is administered before office hysteroscopy.

Misoprostol ( Cytotec) 200 microgram a tablet

Drug

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.

Primary outcomes

  1. Successful office hysteroscopy

    Time frame: During the office hysteroscopy procedure

    A complete hysteroscopic examination of the uterine cavity.

  2. Pain during office hysteroscopy

    Time frame: During the office hysteroscopy procedure. 5 minutes after the procedure. 10 minutes after the procedure.

    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.

Secondary outcomes

  1. Procedure-related complications

    Time frame: During the procedure and up to 24 hours after office hysteroscopy

    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.

  2. Patient satisfaction with cervical preparation

    Time frame: Immediately after the procedure

    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.

  3. Adverse effects of cervical preparation

    Time frame: From date of randomization up to 14 days

    Incidence of adverse effects related to cervical preparation, including abdominal pain, uterine cramping, vaginal bleeding, nausea, vomiting, diarrhea, headache, dizziness, or local vaginal irritation.

Study contacts

Contact information is provided by the study sponsor or research team.

Mohammed Amine Hannachi, Assistant professor

CONTACT

[email protected]

+21699696332

Sponsors and collaborators

Lead sponsor

Faculty of Medicine of Tunis

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 13, 2026
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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