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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00870272

Enrollment

550

Registered

2009-03-27

Start date

2007-07-31

Completion date

2009-03-31

Last updated

2009-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abortion, Induced

Keywords

Medical Abortion, Mifepristone, Misoprostol, Sublingual administration, Buccal administration

Brief summary

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.

Interventions

DRUGMisoprostol

400mcg misoprostol taken sublingually or buccally

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Side effects experienced	July 2007- March 2009

Countries

Moldova

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026