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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00286208
Other study ID # 1.1.5
Secondary ID
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


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
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