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

Gynuity Health Projects

Status: Completed

Conditions: Abortion, Induced

Treatments: Drug: Misoprostol

Study type: Interventional

Funder types: Other

Identifiers

NCT00870272

1.2.0

Details and patient eligibility

About

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.

Enrollment: 550 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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550 participants in 2 patient groups

1

Active Comparator group

Description:

400mcg sublingual misoprostol

Treatment:

Drug: Misoprostol

2

Active Comparator group

Description:

400mcg buccal misoprostol

Treatment:

Drug: Misoprostol