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NCT02534883 · ClinicalTrials.gov registry record · NA

Cervical Ripening in Postmenopausal Women

A NA study, sponsored by St. Louis University.

Terminated
Registry status
NA
Development phase
11
Enrollment target

NCT02534883: Clinical Trial NA study, sponsored by St. Louis University.

NCT02534883 is a NA study that was terminated before completion, run by St. Louis University. The registered enrollment target is 11 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02534883, a NA study, was terminated before completion, sponsored by St. Louis University.

TERMINATED
Registry status
NA
Development phase
11 participants
Enrollment target

Study Summary

Misoprostol (Cytotec) 200ug vaginally will be given to patients 12 hours and 2 hours pre-operatively (before surgery) for a total of 400ug to ripen, soften or relax the cervix for dilation (opening). This is to assist with the insertion of a hysteroscope (the surgical instrument) into the uterus for all operative hysteroscopic procedures requiring dilation above 5 mm. Time required for cervical dilatation will be recorded. Start time will be when the smallest dilator is placed into the endocervical canal, and stop time recorded when the desired cervical dilation is achieved with the largest dilator. Depending on the procedure, desired dilation may range between 5-10mm. Time will serve as a surrogate for operative ease of dilatation. The investigators will compare the two groups in terms of medication, resistance, dilation time and size, side effects and surgical complications.

Primary Outcome

To evaluate the efficacy of two doses of 200ug of misoprostol (for a total of 400ug), administered vaginally, on cervical ripening before diagnostic and operative hysteroscopic procedures in postmenopausal women (amenorrhea greater than 1 year). Efficacy is represented by time to dilation.

Interventions

  • DRUG Placebo
  • DRUG Misoprostol

Trial Details

FieldValue
Enrollment Target 11 participants
Start Date 2015-08
Est. Completion 2016-12
Phase NA
St. Louis University

107 total trials

Why NCT02534883 stopped before completion

NCT02534883 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT02534883 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02534883 about?

NCT02534883 is a clinical study titled "Cervical Ripening in Postmenopausal Women". Misoprostol (Cytotec) 200ug vaginally will be given to patients 12 hours and 2 hours pre-operatively (before surgery) for a total of 400ug to ripen, soften or relax the cervix for dilation (opening). This is to assist with the insertion of a hysteroscope (the surgical instrument) into the uterus for...

What is the current status of trial NCT02534883?

This trial is currently terminated. It is a NA study. The enrollment target is 11 participants. The study started on 2015-08. Estimated completion is 2016-12.

What interventions are being tested in trial NCT02534883?

The interventions under investigation include: Placebo (DRUG), Misoprostol (DRUG).

Who is sponsoring clinical trial NCT02534883?

This trial is sponsored by St. Louis University, which has 107 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02534883's enrollment target sits among peer trials

11 1927th of 2000 higher than 74 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02534883, the US trial registry maintained by the National Library of Medicine. NCT02534883 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.