Study of 400mcg Versus 800mcg Buccal Misoprostol Following Mifepristone 200mg for Abortion up to 63 Days Gestation - Full Text View

Sponsored by:	Gynuity Health Projects
Information provided by:	Gynuity Health Projects
ClinicalTrials.gov Identifier:	NCT00482209

Purpose

This double-blind, randomized study will compare the efficacy and acceptability of mifepristone 200mg followed in 36-48 hours by 400mcg or 800mcg of buccal misoprostol (i.e., in the cheeks) for termination of pregnancy in women up to 63 days LMP.

Condition	Intervention
Induced Abortion	Drug: Mifepristone, misoprostol Drug: mifepristone, misoprostol

Drug Information available for: Mifepristone Misoprostol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver), Dose Comparison, Parallel Assignment, Safety/Efficacy Study

Further study details as provided by Gynuity Health Projects:

Primary Outcome Measures:

Need for surgical completion for ongoing viable pregnancies at follow up visit (Study day 12-15) or for incomplete abortion at extended follow up visit (Study day (19-22). [ Time Frame: Study day 12-15 for ongoing viable pregnancies or Study day 19-22 for incomplete abortion at extended follow up visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Side-effects, acceptability for women [ Time Frame: side effects and acceptability recorded at exit interview ] [ Designated as safety issue: No ]

Estimated Enrollment:	1220
Study Start Date:	May 2007
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 200mg mifepristone followed by 400mcg misoprostol	Drug: Mifepristone, misoprostol 200mg mifepristone followed by 400mcg misoprostol 36-48 hours later
2: Active Comparator 200mg mifepristone followed by 800mcg misoprostol	Drug: mifepristone, misoprostol 200mg mifepristone followed by 800mcg misoprostol 36-48 hours later

Detailed Description:

The goal of this study is to provide answers to the following four questions:

Is a regimen of medical abortion with mifepristone using 400mcg buccal misoprostol as effective and acceptable as using 800mcg buccal misoprostol up to 63 days since the last menstrual period (LMP)?
Are the side effects with buccal use tolerable for women?
Is buccal administration of misoprostol acceptable to women?
When given a choice, do women prefer to take misoprostol at home or in the clinic?

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Women 18 years or over presenting for abortion services who consent to participate
good general health
assessed by a clinician to have an intrauterine pregnancy less than 64 days LMP on Study Day 1 and to be eligible for medical abortion
Have ready access to a telephone and emergency transportation;
Be willing to provide an address and/or telephone number for purposes of follow-up

Exclusion Criteria:

Conditions which contraindicate the use of mifepristone or misoprostol
Women presenting for medical abortion who do not consent to participate

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00482209

Contacts

Contact: Tamuna Tsereteli, MD, MSc, PhD

ttsereteli@gynuity.org

Locations

Georgia
Zhordania Institute of Human Reproduction	Recruiting
Tbilisi, Georgia
Contact: George Tsertsvadze, MD
Sub-Investigator: George Tsertsvadze, MD
Maternity House #2	Recruiting
Tbilisi, Georgia
Contact: George Tevdorashvili, MD
Sub-Investigator: George Tevdorashvili, MD
Maternity House #4	Recruiting
Tbilisi, Georgia
Contact: Nikoloz Manjgaladze, MD
Sub-Investigator: Nikoloz Manjgaladze, MD
Vietnam
Hocmon Hospital	Not yet recruiting
Ho Chi Minh City, Vietnam
Contact: Nguyen Thi Nhu Ngoc, MD
Principal Investigator: Nguyen Thi Nhu Ngoc, MD

Sponsors and Collaborators

Gynuity Health Projects

Investigators

Principal Investigator:	Beverly Winikoff, MD, MPH	Gynuity Health Projects
Study Director:	Erica Chong, MPH	Gynuity Health Projects
Study Director:	Tamuna Tsereteli, MD, MSc, PhD	Gynuity Health Projects

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	Gynuity Health Projects ( Dr. Beverly Winikoff )
Study ID Numbers:	1.1.6
Study First Received:	June 4, 2007
Last Updated:	May 5, 2008
ClinicalTrials.gov Identifier:	NCT00482209
Health Authority:	United States: Institutional Review Board

Keywords provided by Gynuity Health Projects:

mifepristone, misoprostol, medical abortion

Study placed in the following topic categories:

Misoprostol
Mifepristone

Additional relevant MeSH terms:

Abortifacient Agents, Steroidal
Contraceptives, Postcoital, Synthetic
Oxytocics
Contraceptive Agents
Hormone Antagonists
Contraceptives, Oral
Physiological Effects of Drugs
Gastrointestinal Agents
Contraceptive Agents, Female
Hormones, Hormone Substitutes, and Hormone Antagonists

Reproductive Control Agents
Abortifacient Agents, Nonsteroidal
Contraceptives, Postcoital
Luteolytic Agents
Pharmacologic Actions
Therapeutic Uses
Anti-Ulcer Agents
Abortifacient Agents
Menstruation-Inducing Agents
Contraceptives, Oral, Synthetic

ClinicalTrials.gov processed this record on January 16, 2009