Study of Sublingual Versus Oral Misoprostol Administration Following Mifepristone 200 mg for Abortion up to 63 Days Gestation - Full Text View

Purpose

This open-label, randomized study is being conducted to determine whether a dose of 400 mcg of sublingual misoprostol (i.e., under the tongue) taken 24 hours following administration of mifepristone 200 mg is effective and acceptable at inducing an abortion compared with misoprostol taken orally.

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

Is a regimen of medical abortion with mifepristone using sublingual misoprostol at least as effective as using oral misoprostol up to 63 days since the last menstrual period (LMP)?
Are the side effects with sublingual use tolerable for women?
Is sublingual administration of misoprostol acceptable to women?
Is one of the regimens (sublingual or oral) superior in terms of efficacy, safety (side-effects) or acceptability?

Condition	Intervention
Induced Abortion	Drug: Mifepristone, misoprostol


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Randomized Study of Sublingual Versus Oral Misoprostol Administration Following Mifepristone 200 mg for Abortion up to 63 Days Gestation

Resource links provided by NLM:

Drug Information available for: Misoprostol Mifepristone

U.S. FDA Resources

Further study details as provided by Gynuity Health Projects:

Primary Outcome Measures:

Need for surgical completion for incomplete abortions or ongoing viable pregnancies at follow up visit Study day 15. [ Time Frame: 2 weeks after mifepristone administration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Side effects [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
Acceptability for women [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]


Enrollment:	1443
Study Start Date:	August 2005
Study Completion Date:	January 2008
Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Sublingual Misoprostol 400 mcg of sublingual misoprostol	Drug: Mifepristone, misoprostol
Active Comparator: Oral Misoprostol Misoprostol administered orally	Drug: Mifepristone, misoprostol

Eligibility


Ages Eligible for Study:	Child, Adult, Senior
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Women presenting for medical abortion who consent to participate
Possibility of final gestational age of less than or equal to 63 days
General good health
Willing to provide contact information 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00286208

Locations


Moldova, Republic of
State University of Medicine and Pharmacy
Chisinau, Moldova, Republic of
Tunisia
Centre de Planification Familiale de l'Ariana
Ariana, Tunisia
Centre de Planification Familiale la Bardo
Tunis, Tunisia
Maternité de La Rabta
Tunis, Tunisia
Private clinic
Tunis, Tunisia
Turkey
Dr. Zekai Tahir Burak Women's Health Training and Research Hospital
Ankara, Turkey
MoH Ankara Etlik Maternity and Gyneacological Training Hospital
Ankara, Turkey
Haydarpaşa Numune Training and Research Hospital Family Planning Clinic
Istanbul, Turkey
Ege Maternity and Gyneacological Training and Research Hospital
Izmir, Turkey

Sponsors and Collaborators

Gynuity Health Projects

Investigators


Study Director:	Sheila Raghavan, M.Sc.	Gynuity Health Projects
Principal Investigator:	Beverly Winikoff, MD, MPH	Gynuity Health Projects
Study Director:	Rasha Dabash, MPH	Gynuity Health Projects
Principal Investigator:	Selma Hajri, MD	Reproductive Health Consultant
Principal Investigator:	Ayse Akin, MD, MPH	Baskent University
Study Director:	Ilana Dzuba, MHS	Gynuity Health Projects

More Information


Responsible Party:	Gynuity Health Projects
ClinicalTrials.gov Identifier:	NCT00286208 History of Changes
Other Study ID Numbers:	1.1.5
Study First Received:	February 1, 2006
Last Updated:	February 18, 2014
Health Authority:	Moldova: Hospital Ethical Review Committee

Keywords provided by Gynuity Health Projects:


Medical abortion mifepristone misoprostol

Additional relevant MeSH terms:


Misoprostol Mifepristone Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents Physiological Effects of Drugs Anti-Ulcer Agents Gastrointestinal Agents Oxytocics Abortifacient Agents, Steroidal	Contraceptives, Oral, Synthetic Contraceptives, Oral Contraceptive Agents, Female Contraceptive Agents Contraceptives, Postcoital, Synthetic Contraceptives, Postcoital Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Luteolytic Agents Menstruation-Inducing Agents

ClinicalTrials.gov processed this record on September 27, 2016