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
Recruitment status was Recruiting
Sponsor:
Western Galilee Hospital-Nahariya
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
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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 May 21, 2013