Study of 400mcg Versus 800mcg Buccal Misoprostol Following Mifepristone 200mg for Abortion up to 63 Days Gestation

Gynuity Health Projects

Status: Completed

Conditions: Induced Abortion

Treatments: Drug: mifepristone, misoprostol; Drug: Mifepristone, misoprostol

Study type: Interventional

Funder types: Other

Identifiers

NCT00482209

1.1.6

Details and patient eligibility

About

This double-blind, randomized study will compare the efficacy and acceptability of mifepristone 200mg followed in 36-48 hours by 400mcg or 800mcg of buccal misoprostol (i.e., in the cheeks) for termination of pregnancy in women up to 63 days LMP.

Full description

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

1. Is a regimen of medical abortion with mifepristone using 400mcg buccal misoprostol as effective and acceptable as using 800mcg buccal misoprostol up to 63 days since the last menstrual period (LMP)?
2. Are the side effects with buccal use tolerable for women?
3. Is buccal administration of misoprostol acceptable to women?
4. When given a choice, do women prefer to take misoprostol at home or in the clinic?

Enrollment: 1,220 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Women 18 years or over presenting for abortion services who consent to participate
• good general health
• assessed by a clinician to have an intrauterine pregnancy less than 64 days LMP on Study Day 1 and to be eligible for medical abortion
• Have ready access to a telephone and emergency transportation;
• Be willing to provide an address and/or telephone number 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: Double Blind

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1,220 participants in 2 patient groups

1

Active Comparator group

Description:

200mg mifepristone followed by 400mcg misoprostol

Treatment:

Drug: Mifepristone, misoprostol

2

Active Comparator group

Description:

200mg mifepristone followed by 800mcg misoprostol

Treatment:

Drug: mifepristone, misoprostol