Study of 400mcg Sublingual Versus 400mcg Buccal Misoprostol Following 200mg Mifepristone for Medical Abortion up to 63 Days Last Menstrual Period (LMP)

This study has been completed.
Sponsor:
Information provided by:
Gynuity Health Projects
ClinicalTrials.gov Identifier:
NCT00870272
First received: March 26, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted
  Purpose

This open-label, randomized study is being conducted to determine whether a dose of 400 mcg of buccal misoprostol (i.e., in the cheek) taken 24 hours following administration of mifepristone 200 mg is as effective and acceptable at inducing an abortion compared with misoprostol taken sublingually (under the tongue). Women presenting for voluntary termination of intrauterine pregnancy with gestational ages of <63 days will be offered the option of participating in the study.


Condition Intervention
Abortion, Induced
Drug: Misoprostol

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

Resource links provided by NLM:


Further study details as provided by Gynuity Health Projects:

Primary Outcome Measures:
  • Comparison of safety and efficacy of 2 different routes of misoprostol after mifepristone administration [ Time Frame: July 2007-March 2009 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Side effects experienced [ Time Frame: July 2007- March 2009 ] [ Designated as safety issue: Yes ]

Enrollment: 550
Study Start Date: July 2007
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
400mcg sublingual misoprostol
Drug: Misoprostol
400mcg misoprostol taken sublingually or buccally
Active Comparator: 2
400mcg buccal misoprostol
Drug: Misoprostol
400mcg misoprostol taken sublingually or buccally

  Eligibility

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

Inclusion Criteria:

  • Gestational age less than or equal to 63 days
  • General good health including absence of conditions which contraindicate the use of mifepristone and misoprostol for pregnancy termination; and
  • Willing to provide an address and/or telephone number for purposes of follow-up.

Exclusion Criteria:

  • Confirmed or suspected ectopic pregnancy or undiagnosed adnexal mass
  • IUD in place
  • Chronic renal failure
  • Concurrent long-term corticosteroid therapy
  • History of allergy to mifepristone, misoprostol or other prostaglandin
  • Hemorrhagic disorders or concurrent anticoagulant
  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: NCT00870272

Locations
Moldova, Republic of
State University of Medicine and Pharmacy
Chisinau, Moldova, Republic of
Sponsors and Collaborators
Gynuity Health Projects
Investigators
Principal Investigator: Beverly Winikoff, MD, MPH Gynuity Health Projects
Study Director: Sheila Raghavan, MSc Gynuity Health Projects
  More Information

No publications provided

Responsible Party: Beverly Winikoff/President, Gynuity Health Projects
ClinicalTrials.gov Identifier: NCT00870272     History of Changes
Other Study ID Numbers: 1.2.0
Study First Received: March 26, 2009
Last Updated: March 26, 2009
Health Authority: Moldova: Municipal Hospital No. 1

Keywords provided by Gynuity Health Projects:
Medical Abortion
Mifepristone
Misoprostol
Sublingual administration
Buccal administration

Additional relevant MeSH terms:
Mifepristone
Misoprostol
Abortifacient Agents, Steroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
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
Abortifacient Agents, Nonsteroidal
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics

ClinicalTrials.gov processed this record on August 19, 2014