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

Induced Abortion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00286208
• Other study ID #: 1.1.5
• Status: Completed
• Phase: N/A
• First received: February 1, 2006
• Last updated: February 18, 2014
• Start date: August 2005
• Est. completion date: January 2008

Study information

• Verified date: February 2014
• Source: Gynuity Health Projects
• Contact: n/a
• Is FDA regulated: No
• Health authority: Moldova: Hospital Ethical Review Committee
• Study type: Interventional

Clinical Trial 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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1443
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Induced Abortion

Intervention

Drug:
• Mifepristone, misoprostol

Locations

Country	Name	City	State
Moldova, Republic of	State University of Medicine and Pharmacy	Chisinau
Tunisia	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
Turkey	Dr. Zekai Tahir Burak Women's Health Training and Research Hospital	Ankara
Turkey	MoH Ankara Etlik Maternity and Gyneacological Training Hospital	Ankara
Turkey	Haydarpasa Numune Training and Research Hospital Family Planning Clinic	Istanbul
Turkey	Ege Maternity and Gyneacological Training and Research Hospital	Izmir

Sponsors (1)

Lead Sponsor	Collaborator
Gynuity Health Projects

Countries where clinical trial is conducted

Moldova, Republic of,  Tunisia,  Turkey, 

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