Study of 400mcg Sublingual Versus 400mcg Buccal Misoprostol Following 200mg Mifepristone for Medical Abortion up to 63 Days Last Menstrual Period (LMP)

March 26, 2009 updated by: Gynuity Health Projects

A Randomized Study of Sublingual and Buccal Misoprostol Administration Following Mifepristone 200 mg for Abortion up to 63 Days Gestation

This open-label, randomized study is being conducted to determine whether a dose of 400 mcg of buccal misoprostol (i.e., in the cheek) taken 24 hours following administration of mifepristone 200 mg is as effective and acceptable at inducing an abortion compared with misoprostol taken sublingually (under the tongue). Women presenting for voluntary termination of intrauterine pregnancy with gestational ages of <63 days will be offered the option of participating in the study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

550

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Gestational age less than or equal to 63 days
  • General good health including absence of conditions which contraindicate the use of mifepristone and misoprostol for pregnancy termination; and
  • Willing to provide an address and/or telephone number for purposes of follow-up.

Exclusion Criteria:

  • Confirmed or suspected ectopic pregnancy or undiagnosed adnexal mass
  • IUD in place
  • Chronic renal failure
  • Concurrent long-term corticosteroid therapy
  • History of allergy to mifepristone, misoprostol or other prostaglandin
  • Hemorrhagic disorders or concurrent anticoagulant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 1
400mcg sublingual misoprostol
Drug: Misoprostol
400mcg misoprostol taken sublingually or buccally
ACTIVE_COMPARATOR: 2
400mcg buccal misoprostol
Drug: Misoprostol
400mcg misoprostol taken sublingually or buccally

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Comparison of safety and efficacy of 2 different routes of misoprostol after mifepristone administration
Time Frame: July 2007-March 2009
July 2007-March 2009

Secondary Outcome Measures

Outcome Measure
Time Frame
Side effects experienced
Time Frame: July 2007- March 2009
July 2007- March 2009

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gynuity Health Projects

Investigators

  • Study Director: Sheila Raghavan, MSc, Gynuity Health Projects

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (ACTUAL)

March 1, 2009

Study Completion (ACTUAL)

March 1, 2009

Study Registration Dates

First Submitted

March 26, 2009

First Submitted That Met QC Criteria

March 26, 2009

First Posted (ESTIMATE)

March 27, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

March 27, 2009

Last Update Submitted That Met QC Criteria

March 26, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1.2.0

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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