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NCT01011634 · ClinicalTrials.gov registry record · Phase 4

Trial Comparing Intravenous and Oral Moderate Sedation for First Trimester Surgical Abortions

A Phase 4 study, sponsored by University of California, San Francisco.

Terminated
Registry status
Phase 4
Development phase
18
Enrollment target

NCT01011634: Clinical Trial Phase 4 study, sponsored by University of California, San Francisco.

NCT01011634 is a Phase 4 study that was terminated before completion, run by University of California, San Francisco. The registered enrollment target is 18 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01011634, a Phase 4 study, was terminated before completion, sponsored by University of California, San Francisco.

TERMINATED
Registry status
Phase 4
Development phase
18 participants
Enrollment target

Study Summary

In the United States, the majority of first-trimester surgical abortions are performed in outpatient clinics that utilize a wide variety of oral and intravenous regimens for pain control. The specific aim of this study is to evaluate the equivalency of intravenous moderate sedation (fentanyl 100 mcg and midazolam 2 mg) versus oral analgesia/anxiolysis (lorazepam 2 mg sublingual, hydrocodone/acetaminophen 5/500 mg, and ibuprofen 800 mg) for first-trimester surgical abortions. The investigators hypothesize that oral moderate sedation and intravenous moderate sedation will be equivalent in controlling pain as measured by a difference of +/- 10 on a 100-point (range 0-100) visual analog pain scale.

Interventions

  • DRUG Intravenous moderate sedation versus oral medication

Trial Details

FieldValue
Enrollment Target 18 participants
Start Date 2007-05
Est. Completion 2008-11
Phase Phase 4

Why NCT01011634 stopped before completion

NCT01011634 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower).

The record links to 0 conditions, and to 1 intervention - of which Intravenous moderate sedation versus oral medication is the first listed.

NCT01011634 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01011634 about?

NCT01011634 is a clinical study titled "Trial Comparing Intravenous and Oral Moderate Sedation for First Trimester Surgical Abortions". In the United States, the majority of first-trimester surgical abortions are performed in outpatient clinics that utilize a wide variety of oral and intravenous regimens for pain control. The specific aim of this study is to evaluate the equivalency of intravenous moderate sedation (fentanyl 100 mcg...

What is the current status of trial NCT01011634?

This trial is currently terminated. It is a Phase 4 study. The enrollment target is 18 participants. The study started on 2007-05. Estimated completion is 2008-11.

What interventions are being tested in trial NCT01011634?

The interventions under investigation include: Intravenous moderate sedation versus oral medication (DRUG).

Who is sponsoring clinical trial NCT01011634?

This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01011634's enrollment target sits among peer trials

18 1842nd of 2000 higher than 147 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 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 NCT01011634, the US trial registry maintained by the National Library of Medicine. NCT01011634 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.