NCT00920465

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jun 2009

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

June 12, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 15, 2009

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

May 25, 2011

Status Verified

November 1, 2010

Enrollment Period

2.5 years

First QC Date

June 12, 2009

Last Update Submit

May 24, 2011

Conditions

Medical Abortion

Outcome Measures

Primary Outcomes (1)

  • percentage of complete abortion

    one month

Study Arms (2)

one-visit

EXPERIMENTAL
Drug: mifegyne and cytotec

two-visit

ACTIVE COMPARATOR
Drug: mifegyne and cytotec

Interventions

mifegyne and cytotecDRUG

One day dosage versus two days dosage

Also known as: Comparison of one day dosing to two days dosing
one-visittwo-visit

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • inflammation of oral cavity.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Western Galilee Hospital- Nahariya

Nahariya, 22100, Israel

RECRUITING

MeSH Terms

Interventions

MifepristoneMisoprostol

Intervention Hierarchy (Ancestors)

EstrenesEstranesSteroidsFused-Ring CompoundsPolycyclic CompoundsProstaglandins E, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

June 12, 2009

First Posted

June 15, 2009

Study Start

June 1, 2009

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

May 25, 2011

Record last verified: 2010-11

Locations

IL(1)