A Randomized Trial of Buccal Compared to Oral Misoprostol Following Mifepristone for Medical Abortion up to 63 Days LMP

• Status: Completed
• Trial end date: 2007-03-01
• Target enrollment: 0
• Participant gender: Female

Summary

This open-label, randomized study will compare the efficacy, safety, and acceptability of mifepristone 200 mg followed in 24-36 hours either by buccal (i.e., in the cheeks) or oral misoprostol 800 mcg for termination of pregnancy in women up to 63 days L.M.P.

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

Details

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

Criteria

Inclusion Criteria:

• be willing and able to sign consent forms;

• be eligible for medical abortion according to clinician's assessment;

• be willing to undergo a surgical completion if necessary;

• have ready and easy access to a telephone and emergency transportation;

• speak English, Spanish, or have a translator available to translate for all study procedures; and,

• agree to comply with the study procedures and visit schedule.

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 therapy;

• Inherited porphyrias; or

• Other serious physical or mental health conditions.