NCT00286208

Brief Summary

This open-label, randomized study is being conducted to determine whether a dose of 400 mcg of sublingual misoprostol (i.e., under the tongue) taken 24 hours following administration of mifepristone 200 mg is effective and acceptable at inducing an abortion compared with misoprostol taken orally. The goal of this study is to provide answers to the following four questions:

  1. 1.Is a regimen of medical abortion with mifepristone using sublingual misoprostol at least as effective as using oral misoprostol up to 63 days since the last menstrual period (LMP)?
  2. 2.Are the side effects with sublingual use tolerable for women?
  3. 3.Is sublingual administration of misoprostol acceptable to women?
  4. 4.Is one of the regimens (sublingual or oral) superior in terms of efficacy, safety (side-effects) or acceptability?

Trial Health

90
On Track

Trial Health Score

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

Enrollment
1,443

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2005

Typical duration for not_applicable

Geographic Reach
2 countries

5 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 1, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 3, 2006

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
Last Updated

February 19, 2014

Status Verified

February 1, 2014

Enrollment Period

2.4 years

First QC Date

February 1, 2006

Last Update Submit

February 18, 2014

Conditions

Induced Abortion

Keywords

Medical abortionmifepristonemisoprostol

Outcome Measures

Primary Outcomes (1)

  • Need for surgical completion for incomplete abortions or ongoing viable pregnancies at follow up visit Study day 15.

    2 weeks after mifepristone administration

Secondary Outcomes (2)

  • Side effects

    48 hours

  • Acceptability for women

    2 weeks

Study Arms (2)

Sublingual Misoprostol

ACTIVE COMPARATOR

400 mcg of sublingual misoprostol

Drug: Mifepristone, misoprostol

Oral Misoprostol

ACTIVE COMPARATOR

Misoprostol administered orally

Drug: Mifepristone, misoprostol

Interventions

Mifepristone, misoprostolDRUG
Oral MisoprostolSublingual Misoprostol

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Women presenting for medical abortion who consent to participate
  • Possibility of final gestational age of less than or equal to 63 days
  • General good health
  • Willing to provide contact information for purposes of follow-up

You may not qualify if:

  • Conditions which contraindicate the use of mifepristone or misoprostol
  • Women presenting for medical abortion who do not consent to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

State University of Medicine and Pharmacy

Chisinau, Moldova

Location

Centre de Planification Familiale de l'Ariana

Aryanah, Tunisia

Location

Centre de Planification Familiale la Bardo

Tunis, Tunisia

Location

Maternité de La Rabta

Tunis, Tunisia

Location

Private clinic

Tunis, Tunisia

Location

Dr. Zekai Tahir Burak Women's Health Training and Research Hospital

Ankara, Turkey (Türkiye)

Location

MoH Ankara Etlik Maternity and Gyneacological Training Hospital

Ankara, Turkey (Türkiye)

Location

Haydarpaşa Numune Training and Research Hospital Family Planning Clinic

Istanbul, Turkey (Türkiye)

Location

Ege Maternity and Gyneacological Training and Research Hospital

Izmir, Turkey (Türkiye)

Location

MeSH Terms

Interventions

MifepristoneMisoprostol

Intervention Hierarchy (Ancestors)

EstrenesEstranesSteroidsFused-Ring CompoundsPolycyclic CompoundsProstaglandins E, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • Sheila Raghavan, M.Sc.

    Gynuity Health Projects

    STUDY DIRECTOR

  • Beverly Winikoff, MD, MPH

    Gynuity Health Projects

    PRINCIPAL INVESTIGATOR

  • Rasha Dabash, MPH

    Gynuity Health Projects

    STUDY DIRECTOR

  • Selma Hajri, MD

    Reproductive Health Consultant

    PRINCIPAL INVESTIGATOR

  • Ayse Akin, MD, MPH

    Baskent University

    PRINCIPAL INVESTIGATOR

  • Ilana Dzuba, MHS

    Gynuity Health Projects

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2006

First Posted

February 3, 2006

Study Start

August 1, 2005

Primary Completion

January 1, 2008

Study Completion

January 1, 2008

Last Updated

February 19, 2014

Record last verified: 2014-02

Locations

TU(4)MO(1)