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

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ClinicalTrials.gov Identifier: NCT00286208
Recruitment Status : Completed
First Posted : February 3, 2006
Last Update Posted : February 19, 2014
Sponsor:
Information provided by (Responsible Party):
Gynuity Health Projects

Study Description
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Brief Summary:

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:

  1. 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)?
  2. Are the side effects with sublingual use tolerable for women?
  3. Is sublingual administration of misoprostol acceptable to women?
  4. Is one of the regimens (sublingual or oral) superior in terms of efficacy, safety (side-effects) or acceptability?

Condition or disease Intervention/treatment Phase
Induced Abortion Drug: Mifepristone, misoprostol Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1443 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : August 2005
Actual Primary Completion Date : January 2008
Actual Study Completion Date : January 2008

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U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Sublingual Misoprostol
400 mcg of sublingual misoprostol
 Drug: Mifepristone, misoprostol
Active Comparator: Oral Misoprostol
Misoprostol administered orally
 Drug: Mifepristone, misoprostol


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Side effects [ Time Frame: 48 hours ]
  2. Acceptability for women [ Time Frame: 2 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Senior
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Gynuity Health Projects
ClinicalTrials.gov Identifier: NCT00286208     History of Changes
Other Study ID Numbers: 1.1.5
First Posted: February 3, 2006    Key Record Dates
Last Update Posted: February 19, 2014
Last Verified: February 2014

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