Study of Sublingual Versus Oral Misoprostol Administration Following Mifepristone 200 mg for Abortion up to 63 Days Gestation

Gynuity Health Projects

Status: Completed

Conditions: Induced Abortion

Treatments: Drug: Mifepristone, misoprostol

Study type: Interventional

Funder types: Other

Identifiers

NCT00286208

1.1.5

Details and patient eligibility

About

This open-label, randomized study is being conducted to determine whether a dose of 400 mcg of sublingual misoprostol (i.e., under the tongue) taken 24 hours following administration of mifepristone 200 mg is effective and acceptable at inducing an abortion compared with misoprostol taken orally.

The goal of this study is to provide answers to the following four questions:

1. Is a regimen of medical abortion with mifepristone using sublingual misoprostol at least as effective as using oral misoprostol up to 63 days since the last menstrual period (LMP)?
2. Are the side effects with sublingual use tolerable for women?
3. Is sublingual administration of misoprostol acceptable to women?
4. Is one of the regimens (sublingual or oral) superior in terms of efficacy, safety (side-effects) or acceptability?

Enrollment: 1,443 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Women presenting for medical abortion who consent to participate
• Possibility of final gestational age of less than or equal to 63 days
• General good health
• Willing to provide contact information for purposes of follow-up

Exclusion criteria

• Conditions which contraindicate the use of mifepristone or misoprostol
• Women presenting for medical abortion who do not consent to participate

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,443 participants in 2 patient groups

Sublingual Misoprostol

Active Comparator group

Description:

400 mcg of sublingual misoprostol

Treatment:

Drug: Mifepristone, misoprostol

Oral Misoprostol

Active Comparator group

Description:

Misoprostol administered orally

Treatment:

Drug: Mifepristone, misoprostol