NCT01856985

Acceptability of an Out-patient Regimen of Medical Abortion With Mifepristone and 800 Mcg Misoprostol Administered at 78-84 Days Gestation

The Acceptability of an Out-patient Regimen of Medical Abortion With Mifepristone and 800 Mcg Misoprostol Administered Buccally or Sublingually at 78-84 Days Gestation: Two Pilot Studies

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Gynuity Health Projects · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Accepted

Summary

These pilot studies are designed as open label studies to investigate the acceptability of 200 mg mifepristone followed 24-48 hours later by either 1) 800 µg misoprostol administered buccally or 2) 800 µg misoprostol administered sublingually for medical abortion in gestations 78-84 days' LMP. They will be done consecutively. Findings from the pilot studies will guide the development of a larger, multi-site study to investigate the efficacy of outpatient medical abortion regimens for women with gestations from 78 - 84 days LMP. In that end, the pilots seek to collect information on the acceptability of an outpatient medical abortion regimen of 200 mg oral mifepristone followed by either 800 mcg misoprostol delivered either buccally or sublingually safe acceptable? Women's rating of the tolerability of any side effects will also be documented.

Conditions

• Medical Abortion

Interventions

Type	Name	Description
DRUG	Misoprostol
DRUG	Mifepristone

Timeline

• Start date: 2013-04-01
• Primary completion: 2013-09-01
• Completion: 2013-09-01
• First posted: 2013-05-20
• Last updated: 2013-10-11

Locations

1 site across 1 country: Vietnam