NCT00680394

Brief Summary

A double blinded, placebo-controlled randomized trial to compare the safety, efficacy and acceptability of two medical abortion regimens up to 63 days' LMP. The first regimen will include a 200 mg oral dose of mifepristone followed by 800 mcg buccal misoprostol. The second regimen will include two 800 mcg doses of buccal misoprostol. We hypthesize that both methods work well, but that the mifepristone regimen will have an efficacy rate of approximately 95%, and misoprostol alone will be closer to 90%. We will consider a greater than 5% difference to be clinically meaningful.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
440

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2007

Shorter than P25 for not_applicable

Geographic Reach
2 countries

2 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

July 1, 2007

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 3, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
19 days until next milestone

First Posted

Study publicly available on registry

May 20, 2008

Completed
Last Updated

March 13, 2013

Status Verified

March 1, 2013

Enrollment Period

10 months

First QC Date

March 3, 2008

Last Update Submit

March 11, 2013

Conditions

Pregnancy Termination

Keywords

abortionmedical abortionmifepristonemisoprostol

Outcome Measures

Primary Outcomes (1)

  • Efficacy defined as complete abortion without recourse to surgical abortion.

    2 weeks

Study Arms (2)

mifepristone+misoprostol

EXPERIMENTAL

200 mg mifepristone+ 800 mcg buccal misoprostol

Drug: mifepristoneDrug: misoprostol

misoprostol

EXPERIMENTAL

800 mcg buccal misoprostol+placebo

Drug: misoprostolDrug: placebo

Interventions

mifepristoneDRUG

200 mg mifepristone

mifepristone+misoprostol
misoprostolDRUG

800 buccal misoprostol + matching placebo or 1600 buccal misoprostol

mifepristone+misoprostolmisoprostol
placeboDRUG

800 buccal misoprostol + matching placebo or 1600 buccal misoprostol

misoprostol

Eligibility Criteria

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

You may qualify if:

  • Gestational age \< 63 days by LMP, ultrasound or clinical assessment.
  • General good health including absence of conditions which contraindicate the use of mifepristone and misoprostol for pregnancy termination.
  • Agrees to return for follow-up visit and willing to provide an address and/or telephone number for purposes of follow-up.
  • Able to consent to study participation.

You may not qualify if:

  • Gestational age \> 63 days
  • Confirmed or suspected ectopic or molar pregnancy
  • Contraindications to medical abortion including IUD in place (must be removed before procedure), chronic adrenal failure, concurrent long-term corticosteroid therapy, history of allergy to mifepristone, misoprostol or prostaglandin, hemorrhagic disorders or concurrent anticoagulant therapy, inherited porphyries.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

La Rabta Hospital

Tunis, Tunisia

Location

Hung Vuong Hospital

Ho Chi Minh City, Vietnam

Location

Related Publications (2)

  • Blum J, Raghavan S, Dabash R, Ngoc Nt, Chelli H, Hajri S, Conkling K, Winikoff B. Comparison of misoprostol-only and combined mifepristone-misoprostol regimens for home-based early medical abortion in Tunisia and Vietnam. Int J Gynaecol Obstet. 2012 Aug;118(2):166-71. doi: 10.1016/j.ijgo.2012.03.039. Epub 2012 Jun 8.

    PMID: 22682768DERIVED

  • Ngoc NT, Blum J, Raghavan S, Nga NT, Dabash R, Diop A, Winikoff B. Comparing two early medical abortion regimens: mifepristone+misoprostol vs. misoprostol alone. Contraception. 2011 May;83(5):410-7. doi: 10.1016/j.contraception.2010.09.002. Epub 2010 Oct 18.

    PMID: 21477682DERIVED

MeSH Terms

Interventions

MifepristoneMisoprostol

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Beverly Winikoff, MD, MPH

    Gynuity Health Projects

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2008

First Posted

May 20, 2008

Study Start

July 1, 2007

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

March 13, 2013

Record last verified: 2013-03

Locations

TU(1)VN(1)