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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

550 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2009-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Abortion, Induced

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

400mcg sublingual misoprostol

Group Type ACTIVE_COMPARATOR

Misoprostol

Intervention Type DRUG

400mcg misoprostol taken sublingually or buccally

2

400mcg buccal misoprostol

Group Type ACTIVE_COMPARATOR

Misoprostol

Intervention Type DRUG

400mcg misoprostol taken sublingually or buccally

Interventions

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Misoprostol

400mcg misoprostol taken sublingually or buccally

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes