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CompletedNCT00386867Updated Jun 5, 2007

A Randomized Trial of Buccal Compared to Oral Misoprostol Following Mifepristone for Medical Abortion up to 63 Days LMP

An interventional study of 800 mcg misoprostol via oral or buccal administration in Abortion, Induced, sponsored by Gynuity Health Projects. Completed at 8 sites in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2007-06-05.

Sponsored by Gynuity Health Projects · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
1,200
Allocation
Randomized
Ages
18 Years and older
Sex
Female
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Study summary

This open-label, randomized study will compare the efficacy, safety, and acceptability of mifepristone 200 mg followed in 24-36 hours either by buccal (i.e., in the cheeks) or oral misoprostol 800 mcg for termination of pregnancy in women up to 63 days L.M.P.

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Conditions studied

  • Abortion, Induced

Keywords

  • medical abortion
  • mifepristone
  • misoprostol
  • buccal administration
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In context

Lead sponsor

Gynuity Health Projects is the lead sponsor of 112 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • be willing and able to sign consent forms;
  • be eligible for medical abortion according to clinician's assessment;
  • be willing to undergo a surgical completion if necessary;
  • have ready and easy access to a telephone and emergency transportation;
  • speak English, Spanish, or have a translator available to translate for all study procedures; and,
  • agree to comply with the study procedures and visit schedule.

Exclusion criteria

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 therapy;
  • Inherited porphyrias; or
  • Other serious physical or mental health conditions.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
1,200 participants (estimated)

Interventions

  • Drug800 mcg misoprostol via oral or buccal administration
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What researchers measure

Primary outcomes

  1. efficacy

Secondary outcomes

  1. acceptability

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Study locations

8 sites
  • Family Planning Associates Medical Group
    Chicago, Illinois, United States
  • Planned Parenthood League of Massachusetts (Boston clinic)
    Boston, Massachusetts, United States
  • Columbia University Medical Center, Division of Obstetrics & Gynecology
    New York, New York, United States
  • Institute for Urban Family Health
    New York, New York, United States
  • Parkmed
    New York, New York, United States
  • University of Pittsburgh, Division of Obstetrics, Gynecology and Reproductive Sciences
    Pittsburgh, Pennsylvania, United States
  • Whole Women's Health
    Austin, Texas, United States
  • Planned Parenthood
    Waco, Texas, United States
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References and documents

Publications

  • Winikoff B, Dzuba IG, Creinin MD, Crowden WA, Goldberg AB, Gonzales J, Howe M, Moskowitz J, Prine L, Shannon CS. Two distinct oral routes of misoprostol in mifepristone medical abortion: a randomized controlled trial. Obstet Gynecol. 2008 Dec;112(6):1303-1310. doi: 10.1097/AOG.0b013e31818d8eb4. PubMed 19037040 ↗

Related links

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 5, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00386867
Lead sponsor
Gynuity Health Projects
First posted
Oct 12, 2006
Start date
Oct 2006
Completion
Mar 2007
Last update
Jun 5, 2007

Study contacts

Beverly Winikoff, MD, MPH
principal investigator · Gynuity Health Projects
Ilana Dzuba, MHS
study director · Gynuity Health Projects

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2007. You cannot join it, but the record below documents what was studied.

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