NCT02720991

Brief Summary

A pilot study on the acceptability and feasibility with Mifepristone and 400 mg of sub-lingual Misoprostol between 71-77 and 78-84 days of gestation for 50 cases.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2014

Shorter than P25 for phase_4

Status
completed

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

July 1, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

March 10, 2016

Completed
18 days until next milestone

First Posted

Study publicly available on registry

March 28, 2016

Completed
Last Updated

March 28, 2016

Status Verified

March 1, 2016

Enrollment Period

9 months

First QC Date

March 10, 2016

Last Update Submit

March 22, 2016

Conditions

Abortion, 3 Months

Outcome Measures

Primary Outcomes (1)

  • Acceptability of an ambulatory medical abortion treatment of 200 mg of mifepristone orally followed b 400 mcg of sublingual misoprostol at home, based on responses to questionnaire

    1 week

Secondary Outcomes (1)

  • Level of tolerance of side effects, based on responses to questionnaire

    1 week

Study Arms (1)

Mifepristone and sublingual misoprostol

EXPERIMENTAL

200 mg mifepristone and 400 ug sublingual misoprostol

Drug: MifepristoneDrug: Sublingual misoprostol

Interventions

MifepristoneDRUG

200 mg of oral mifepristone

Also known as: miropristone, Mifeprex, Mifegyn
Mifepristone and sublingual misoprostol
Sublingual misoprostolDRUG

400 ug of misoprostol sublingually following mifepristone

Also known as: cytotec
Mifepristone and sublingual misoprostol

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Gestational age of 71-84 days of amenorrhea
  • Seeking abortion services
  • Prepared and able to sign the consent forms
  • Accept to conform to study procedures and scheduled visits

You may not qualify if:

  • Does not meet study criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2016

First Posted

March 28, 2016

Study Start

July 1, 2014

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

March 28, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share