Comparing Two Regimens for Medical Abortion: Mifepristone+Misoprostol Versus Misoprostol Alone

• Status: Completed
• Trial end date: 2008-05-01
• Target enrollment: 0
• Participant gender: Female

Summary

A double blinded, placebo-controlled randomized trial to compare the safety, efficacy and acceptability of two medical abortion regimens up to 63 days' LMP. The first regimen will include a 200 mg oral dose of mifepristone followed by 800 mcg buccal misoprostol. The second regimen will include two 800 mcg doses of buccal misoprostol. We hypthesize that both methods work well, but that the mifepristone regimen will have an efficacy rate of approximately 95%, and misoprostol alone will be closer to 90%. We will consider a greater than 5% difference to be clinically meaningful.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Gynuity Health Projects
• Treatments: Mifepristone; Misoprostol

Criteria

Inclusion Criteria:

• Gestational age < 63 days by LMP, ultrasound or clinical assessment.

• General good health including absence of conditions which contraindicate the use of mifepristone and misoprostol for pregnancy termination.

• Agrees to return for follow-up visit and willing to provide an address and/or telephone number for purposes of follow-up.

• Able to consent to study participation.

Exclusion Criteria:

• Gestational age > 63 days

• Confirmed or suspected ectopic or molar pregnancy

• Contraindications to medical abortion including IUD in place (must be removed before procedure), chronic adrenal failure, concurrent long-term corticosteroid therapy, history of allergy to mifepristone, misoprostol or prostaglandin, hemorrhagic disorders or concurrent anticoagulant therapy, inherited porphyries.