NCT00386282

Brief Summary

This study examined the acceptability and feasibility of introducing a mifepristone-misoprostol regimen of medical abortion into abortion services in two private clinics in Puerto Rico; 2 clinics in Baku, Azerbaijan; 3 clinics in Yerevan, Armenia; and 4 clinics in Mexico City. It was hypothesized that the study regimen would be both acceptable and efficacious.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
1,250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2006

Longer than P75 for not_applicable

Geographic Reach
4 countries

11 active sites

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

September 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 9, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 11, 2006

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

July 30, 2014

Status Verified

July 1, 2014

Enrollment Period

4.5 years

First QC Date

October 9, 2006

Last Update Submit

July 29, 2014

Conditions

Abortion, First Trimester

Keywords

MifepristoneMisoprostolBuccal administration

Outcome Measures

Primary Outcomes (1)

  • efficacy

    15 days

Secondary Outcomes (1)

  • acceptability

    15 days

Study Arms (1)

mifepristone-misoprostol treatment

OTHER

200 mg mifepristone followed by 800 mcg buccal misoprostol 24-48 hours after the mifepristone

Drug: mifepristone-misoprostol treatment

Interventions

mifepristone-misoprostol treatmentDRUG

200 mg mifepristone followed by 800 mcg buccal misoprostol 24-48 hours after the mifepristone.

Also known as: medical abortion
mifepristone-misoprostol treatment

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Gestation up to 63 days
  • General good health
  • Willingness to provide contact information for follow-up
  • Absence of conditions which contraindicate the use of mifepristone and misoprostol for pregnancy termination

You may not qualify if:

  • Ectopic pregnancy
  • Intrauterine device (IUD) in place

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Center for Family Planning and Sexual Health

Yerevan, Armenia

Location

Institute of Perinatology, Obstetrics and Gynecology

Yerevan, Armenia

Location

State Medical University

Yerevan, Armenia

Location

Family Planning Center

Baku, Azerbaijan

Location

Scientific Research Institute of Obstetrics and Gynecology

Baku, Azerbaijan

Location

C.S. Beatriz Velasco Aleman

Mexico City, Federal District, Mexico

Location

C.S. Santa Catarina

Mexico City, Federal District, Mexico

Location

H.G. Enrique Cabrera

Mexico City, Federal District, Mexico

Location

H.M.I Inguaran

Mexico City, Federal District, Mexico

Location

Clinica de Planificacion Familiar

Lomas Verdes, Bayamon, 00956, Puerto Rico

Location

Woman's Metropolitan Center

San Juan, 00921, Puerto Rico

Location

Related Publications (1)

  • Pena M, Dzuba IG, Smith PS, Mendoza LJ, Bousieguez M, Martinez ML, Polanco RR, Villalon AE, Winikoff B. Efficacy and acceptability of a mifepristone-misoprostol combined regimen for early induced abortion among women in Mexico City. Int J Gynaecol Obstet. 2014 Oct;127(1):82-5. doi: 10.1016/j.ijgo.2014.04.012. Epub 2014 Jun 4.

    PMID: 24957534DERIVED

Study Officials

  • Hector Diaz Martinez, MD

    Clinica de Planificacion Familiar

    PRINCIPAL INVESTIGATOR

  • Angela Arredondo, MD

    Woman's Metropolitan Center

    PRINCIPAL INVESTIGATOR

  • Beverly Winikoff, MD, MPH

    Gynuity Health Projects

    PRINCIPAL INVESTIGATOR

  • Gulnara Rzaeva, MD

    Scientific Research Institute of Obstetrics & Gynecology

    PRINCIPAL INVESTIGATOR

  • Besti Muradova, MD

    Family Planning Center

    PRINCIPAL INVESTIGATOR

  • Susanna Fildjyan, MD

    Institute of Perinatology, Obstetrics and Gynecology

    PRINCIPAL INVESTIGATOR

  • Armine Harutyunyan, MD

    Center for Family Planning and Sexual Health

    PRINCIPAL INVESTIGATOR

  • Anna Aghajanyan, MD

    State Medical University

    PRINCIPAL INVESTIGATOR

  • Ranulfo Rios, MD

    H G Enrique Cabrera

    PRINCIPAL INVESTIGATOR

  • Laura Garcia Martinez, MD

    H.M.I Inguaran

    PRINCIPAL INVESTIGATOR

  • Antonio E Flores, MD

    C S Beatriz Velasco Aleman

    PRINCIPAL INVESTIGATOR

  • Elba Margarita Lugo Hernandez, MD

    C S Santa Catarina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 9, 2006

First Posted

October 11, 2006

Study Start

September 1, 2006

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

July 30, 2014

Record last verified: 2014-07

Locations

AR(3)PR(2)AZ(2)ME(4)