WithdrawnPhase 4

Misoprostol in Office Hysteroscopy and Endometrial Biopsy

Stopped: Unable to get patients interested in the study

United States0Started 2018-09-01

Plain-language summary

We hypothesize that use of vaginal misoprostol will help in reducing the pain scores when used prior to concurrent office hysteroscopy and endometrial biopsy in a particular subgroup of women who are anticipated to require cervical dilatation.

Who can participate

Age range

18 Years – 70 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: All consecutive female patients aged 18-70 years presenting to the Center for successive OH and EMB with the ability to provide written informed consent and meets at least one of the criteria mentioned below: * Previous cesarean section * Nulliparous * Postmenopausal * Previous loop electrosurgical excision procedure (LEEP) or cone biopsy * Previous myomectomy Exclusion Criteria: Premenopausal multiparous women with no prior surgeries performed on the uterus. * Patients unable to provide informed consent * Patients visiting the fibroid and endometriosis center with abnormal uterine bleeding, infertility or for preoperative evaluation; however, OH and EMB is not required for their evaluation based on their providers' clinical judgment. * Patients with genital tract lesions.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Pain score recorded in VAS

Timeframe: Day of procedure

Trial details

NCT IDNCT03547778

SponsorUniversity of South Florida

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-12-31

View on ClinicalTrials.gov More Office Hysteroscopy and Endometrial Biopsy trials