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CompletedNCT01173003Updated Feb 19, 2014

Expansion Study of a Simplified Regimen of Medical Abortion Thru 63 Last Menstrual Period (LMP) in Tunisia

An interventional study of Mifepristone, misoprostol in Induced Abortion, sponsored by Gynuity Health Projects. Completed at 1 site in Tunisia. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-02-19.

Sponsored by Gynuity Health Projects · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
688
Allocation
Not applicable
Sex
Female
01

Study summary

This open-label study is being conducted to determine whether national expansion of a 400 mcg of sublingual misoprostol (i.e., under the tongue) taken 24 hours following administration of mifepristone 200 mg is effective and acceptable to new abortion providers in 14 regions.

The goal of this study is to provide answers to the following four questions:

  1. What is the effectiveness of this regimen of medical abortion with mifepristone followed by 400 mcg sublingual 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. Are women satisfied with counseling and services received in new centers offering medical abortion?
02

Conditions studied

  • Induced Abortion

Keywords

  • Medical abortion
  • mifepristone
  • misoprostol
  • Tunisia
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
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
688 participants (actual)

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

1 site
  • Centres (14) de Planification Familiale de L'ONFP
    Tunis, Various, Tunisia
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
NCT01173003
Lead sponsor
Gynuity Health Projects
Collaborators
Centre de Formation et de la Recherche, Tunisia
Responsible party
Sponsor
First posted
Jul 30, 2010
Start date
Jun 2009
Primary completion
Dec 2011
Completion
Dec 2011
Last update
Feb 19, 2014

Study contacts

Beverly Winikoff, MD, MPH
study chair · Gynuity Health Projects
Rasha Dabash, MPH
study director · Gynuity Health Projects
Selma Hajri, MD
principal investigator · Reproductive Health Consultant
Mongia Ben Attia, MD
principal investigator · Office Nationale de la Famille et de la Population
N Gueddana, MD
study chair · ONFP
Fatma Temimi, MD
principal investigator · ONFP
E Hassairi
principal investigator · ONFP
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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