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Trial record 3 of 59 for:    abortion , gynuity

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00870272
Recruitment Status : Completed
First Posted : March 27, 2009
Last Update Posted : March 27, 2009
Information provided by:
Gynuity Health Projects

Brief Summary:
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 or disease Intervention/treatment Phase
Abortion, Induced Drug: Misoprostol Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 550 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : July 2007
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Comparison of safety and efficacy of 2 different routes of misoprostol after mifepristone administration [ Time Frame: July 2007-March 2009 ]

Secondary Outcome Measures :
  1. Side effects experienced [ Time Frame: July 2007- March 2009 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

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 identifier (NCT number): NCT00870272

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

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Responsible Party: Beverly Winikoff/President, Gynuity Health Projects Identifier: NCT00870272     History of Changes
Other Study ID Numbers: 1.2.0
First Posted: March 27, 2009    Key Record Dates
Last Update Posted: March 27, 2009
Last Verified: March 2009
Keywords provided by Gynuity Health Projects:
Medical Abortion
Sublingual administration
Buccal administration
Additional relevant MeSH terms:
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Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
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