NCT00870272

Brief Summary

This open-label, randomized study is being conducted to determine whether a dose of 400 mcg of buccal misoprostol (i.e., in the cheek) taken 24 hours following administration of mifepristone 200 mg is as effective and acceptable at inducing an abortion compared with misoprostol taken sublingually (under the tongue). Women presenting for voluntary termination of intrauterine pregnancy with gestational ages of \<63 days will be offered the option of participating in the study.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
550

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

March 26, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 27, 2009

Completed
Last Updated

March 27, 2009

Status Verified

March 1, 2009

Enrollment Period

1.7 years

First QC Date

March 26, 2009

Last Update Submit

March 26, 2009

Conditions

Abortion, Induced

Keywords

Medical AbortionMifepristoneMisoprostolSublingual administrationBuccal administration

Outcome Measures

Primary Outcomes (1)

  • Comparison of safety and efficacy of 2 different routes of misoprostol after mifepristone administration

    July 2007-March 2009

Secondary Outcomes (1)

  • Side effects experienced

    July 2007- March 2009

Study Arms (2)

1

ACTIVE COMPARATOR

400mcg sublingual misoprostol

Drug: Misoprostol

2

ACTIVE COMPARATOR

400mcg buccal misoprostol

Drug: Misoprostol

Interventions

MisoprostolDRUG

400mcg misoprostol taken sublingually or buccally

12

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Gestational age less than or equal to 63 days
  • General good health including absence of conditions which contraindicate the use of mifepristone and misoprostol for pregnancy termination; and
  • Willing to provide an address and/or telephone number for purposes of follow-up.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

State University of Medicine and Pharmacy

Chisinau, Moldova

Location

MeSH Terms

Interventions

Misoprostol

Intervention Hierarchy (Ancestors)

Prostaglandins E, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • Beverly Winikoff, MD, MPH

    Gynuity Health Projects

    PRINCIPAL INVESTIGATOR

  • Sheila Raghavan, MSc

    Gynuity Health Projects

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 26, 2009

First Posted

March 27, 2009

Study Start

July 1, 2007

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

March 27, 2009

Record last verified: 2009-03

Locations

MO(1)