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Completed

NCT Number: NCT00870272

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

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.

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Key information

Conditions

Abortion, Induced

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

State University of Medicine and Pharmacy

Chisinau, Moldova

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Misoprostol

Drug

400mcg misoprostol taken sublingually or buccally

Primary outcomes

  1. Comparison of safety and efficacy of 2 different routes of misoprostol after mifepristone administration

    Time frame: July 2007-March 2009

Secondary outcomes

  1. Side effects experienced

    Time frame: July 2007- March 2009

Sponsors and collaborators

Lead sponsor

Gynuity Health Projects

Other

Registry information

Official study title

A Randomized Study of Sublingual and Buccal Misoprostol Administration Following Mifepristone 200 mg for Abortion up to 63 Days Gestation

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Mar 27, 2009
Registry last updated
Mar 27, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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