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Clinical Trials/NCT00386867
NCT00386867
Completed
Not Applicable

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

Gynuity Health Projects8 sites in 1 country1,200 target enrollmentOctober 2006
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ConditionsAbortion, Induced
Drugs800 mcg misoprostol via oral or buccal administration

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Abortion, Induced
Sponsor
Gynuity Health Projects
Enrollment
1200
Locations
8
Primary Endpoint
efficacy
Status
Completed
Last Updated
18 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
October 2006
End Date
March 2007
Last Updated
18 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Sponsor
Gynuity Health Projects

Eligibility 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.

Outcomes

Primary Outcomes

efficacy

Secondary Outcomes

  • acceptability

Study Sites (8)

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