Treatment Regimens for Mifegyne and Cytotec

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Western Galilee Hospital-Nahariya.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Western Galilee Hospital-Nahariya
ClinicalTrials.gov Identifier:
NCT00920465
First received: June 12, 2009
Last updated: May 24, 2011
Last verified: November 2010
  Purpose

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.


Condition Intervention Phase
Medical Abortion
Drug: mifegyne and cytotec
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of the Effectiveness of Abortive Measures From the Administration of Mifegyne and Cytotec at One and Two Visits

Resource links provided by NLM:


Further study details as provided by Western Galilee Hospital-Nahariya:

Primary Outcome Measures:
  • percentage of complete abortion [ Time Frame: one month ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: June 2009
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: one-visit Drug: mifegyne and cytotec
One day dosage versus two days dosage
Other Name: Comparison of one day dosing to two days dosing
Active Comparator: two-visit Drug: mifegyne and cytotec
One day dosage versus two days dosage
Other Name: Comparison of one day dosing to two days dosing

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • above age 18,
  • for whom Mifegyne and cytotec are indicated.

Exclusion Criteria:

  • inflammation of oral cavity.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00920465

Locations
Israel
Western Galilee Hospital- Nahariya Recruiting
Nahariya, Israel, 22100
Contact: Renee Tendler, MD       renee16@walla.com   
Sponsors and Collaborators
Western Galilee Hospital-Nahariya
  More Information

No publications provided

Responsible Party: Dr. Renee Tendler, Western Galilee Hospital-Nahariya
ClinicalTrials.gov Identifier: NCT00920465     History of Changes
Other Study ID Numbers: 4-10-2007
Study First Received: June 12, 2009
Last Updated: May 24, 2011
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Mifepristone
Misoprostol
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptives, Postcoital, Synthetic
Contraceptives, Postcoital
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Luteolytic Agents
Menstruation-Inducing Agents
Abortifacient Agents, Steroidal
Abortifacient Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics
Abortifacient Agents, Nonsteroidal

ClinicalTrials.gov processed this record on April 17, 2014