Treatment Regimens for Mifegyne and Cytotec

Medical Abortion Clinical Trial

Official title:

Comparison of the Effectiveness of Abortive Measures From the Administration of Mifegyne and Cytotec at One and Two Visits

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00920465
• Other study ID #: 4-10-2007
• Status: Recruiting
• Phase: Phase 3
• First received: June 12, 2009
• Last updated: May 24, 2011
• Start date: June 2009
• Est. completion date: December 2011

Study information

• Verified date: November 2010
• Source: Western Galilee Hospital-Nahariya
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to test two regimens of mifegyne and cytotec for medical abortion. The investigators hypothesize that administration of both medications during one hospital visit will not compromise effectiveness.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• above age 18,

• for whom Mifegyne and cytotec are indicated.

Exclusion Criteria:

• inflammation of oral cavity.

Study Design

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

Related Conditions & MeSH terms

• Medical Abortion

Intervention

Drug:
• mifegyne and cytotec
One day dosage versus two days dosage

Locations

Country	Name	City	State
Israel	Western Galilee Hospital- Nahariya	Nahariya

Sponsors (1)

Lead Sponsor	Collaborator
Western Galilee Hospital-Nahariya

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percentage of complete abortion		one month	No