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CompletedNCT00286208Updated Feb 19, 2014

Study of Sublingual Versus Oral Misoprostol Administration Following Mifepristone 200 mg for Abortion up to 63 Days Gestation

An interventional study of Mifepristone, misoprostol in Induced Abortion, sponsored by Gynuity Health Projects. Completed at 9 sites in 3 countries. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-02-19.

Sponsored by Gynuity Health Projects · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
1,443
Allocation
Randomized
Sex
Female
01

Study 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. 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. Are the side effects with sublingual use tolerable for women?
  3. Is sublingual administration of misoprostol acceptable to women?
  4. Is one of the regimens (sublingual or oral) superior in terms of efficacy, safety (side-effects) or acceptability?
02

Conditions studied

  • Induced Abortion

Keywords

  • Medical abortion
  • mifepristone
  • misoprostol
03

In context

Lead sponsor

Gynuity Health Projects is the lead sponsor of 112 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Conditions which contraindicate the use of mifepristone or misoprostol
  • Women presenting for medical abortion who do not consent to participate
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,443 participants (actual)

Study arms

  • Active comparator
    Sublingual Misoprostol

    400 mcg of sublingual misoprostol

    Drug: Mifepristone, misoprostol

  • Active comparator
    Oral Misoprostol

    Misoprostol administered orally

    Drug: Mifepristone, misoprostol

Interventions

  • DrugMifepristone, misoprostol
06

What researchers measure

Primary outcomes

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

    Time frame: 2 weeks after mifepristone administration

Secondary outcomes

  1. Side effects

    Time frame: 48 hours

  2. Acceptability for women

    Time frame: 2 weeks

07

Study locations

9 sites
  • State University of Medicine and Pharmacy
    Chisinau, Moldova, Republic of
  • Centre de Planification Familiale de l'Ariana
    Ariana, Tunisia
  • Centre de Planification Familiale la Bardo
    Tunis, Tunisia
  • Maternité de La Rabta
    Tunis, Tunisia
  • Private clinic
    Tunis, Tunisia
  • Dr. Zekai Tahir Burak Women's Health Training and Research Hospital
    Ankara, Turkey
  • MoH Ankara Etlik Maternity and Gyneacological Training Hospital
    Ankara, Turkey
  • Haydarpaşa Numune Training and Research Hospital Family Planning Clinic
    Istanbul, Turkey
  • Ege Maternity and Gyneacological Training and Research Hospital
    Izmir, Turkey
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 19, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00286208
Lead sponsor
Gynuity Health Projects
Responsible party
Sponsor
First posted
Feb 3, 2006
Start date
Aug 2005
Primary completion
Jan 2008
Completion
Jan 2008
Last update
Feb 19, 2014

Study contacts

Sheila Raghavan, M.Sc.
study director · Gynuity Health Projects
Beverly Winikoff, MD, MPH
principal investigator · Gynuity Health Projects
Rasha Dabash, MPH
study director · Gynuity Health Projects
Selma Hajri, MD
principal investigator · Reproductive Health Consultant
Ayse Akin, MD, MPH
principal investigator · Baskent University
Ilana Dzuba, MHS
study director · Gynuity Health Projects
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.

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