Treatment Regimens for Mifegyne and Cytotec | NCT00920465

Studies
Treatment Regimens for Mifegyne and Cytotec

NCT00920465

Sponsor

Western Galilee Hospital-Nahariya

Status

Unknown status

Last Update Posted

May 25, 2011Estimated

Enrollment

200Estimated

Phase

Phase 3

Conditions

Medical Abortion

Interventions

mifegyne and cytotec

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2009

Primary Completion Date

Dec 2011Estimated

Completion Date

Dec 2011Estimated

First Submitted Date

Jun 12, 2009

First Submission Date that Met QC Criteria

Jun 12, 2009

First Posted Date

Jun 15, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 24, 2011

Last Update Posted Date

May 25, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
one-visit	Experimental		Drug: mifegyne and cytotec
two-visit	Active Comparator		Drug: mifegyne and cytotec

Interventions

Name	Type	Description	Arm Group Labels	Other Names
mifegyne and cytotec	Drug	One day dosage versus two days dosage	one-visit two-visit

Measure	Description	Time Frame
percentage of complete abortion		one month

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

inflammation of oral cavity.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Western Galilee Hospital- Nahariya	Recruiting	Nahariya		22100	Israel

Intervention Browse Module

MeSH Terms

ID	Term
D015735	Mifepristone
D016595	Misoprostol

Ancestor Terms

ID	Term
D004963	Estrenes
D004962	Estranes
D013256	Steroids
D000072473	Fused-Ring Compounds

Browse Leaves

Not provided

Browse Branches

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