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

Induced Abortion Clinical Trial

Official title:

An Open Label Study of 400 mcg Sublingual Misoprostol Following Mifepristone 200 mg for Abortion up to 63 Days LMP

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01173003
• Other study ID #: 1.1.7
• Status: Completed
• Phase: N/A
• First received: July 28, 2010
• Last updated: February 18, 2014
• Start date: June 2009
• Est. completion date: December 2011

Study information

• Verified date: February 2014
• Source: Gynuity Health Projects
• Contact: n/a
• Is FDA regulated: No
• Health authority: Tunisia: Comite de l'Office Nationale de la Famille et la Population
• Study type: Interventional

Clinical Trial 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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 688
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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:

• Conditions which contraindicate the use of mifepristone or misoprostol

• Women presenting for medical abortion who do not consent to participate

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Induced Abortion

Intervention

Drug:
• Mifepristone, misoprostol

Locations

Country	Name	City	State
Tunisia	Centres (14) de Planification Familiale de L'ONFP	Tunis	Various

Sponsors (2)

Lead Sponsor	Collaborator
Gynuity Health Projects	Centre de Formation et de la Recherche, Tunisia

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Need for surgical completion for incomplete abortions or ongoing viable pregnancies at follow up visit Study day 15.		2 weeks after mifepristone administration	No
Secondary	Side effects		48 hours	No
Secondary	Acceptability for women		2 weeks	No