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

NCT01387256 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 441

Last updated 2011-07-20

No results posted yet for this study

Summary

This double blinded, placebo-controlled randomized trial will compare the safety, efficacy and acceptability of two medical abortion regimens up to 63 days since last Menstrual Period (LMP) in Tunisia and Vietnam. 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 three hours apart. All drugs are administered AT home by the participant.

Conditions

  • Complete Abortion

Interventions

DRUG

medical abortion

pregnancy termination with drugs

Sponsors & Collaborators

  • Gynuity Health Projects

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2010-07-31
Completion
2010-07-31

Countries

  • Tunisia
  • Vietnam

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01387256 on ClinicalTrials.gov