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OpenTrials
Completed

NCT Number: NCT00386867

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

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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Key information

Conditions

Abortion, Induced

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Family Planning Associates Medical Group, Chicago, Illinois, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

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

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

  • 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.

Treatment and study plan

800 mcg misoprostol via oral or buccal administration

Drug

Primary outcomes

  1. efficacy

Secondary outcomes

  1. acceptability

Sponsors and collaborators

Lead sponsor

Gynuity Health Projects

Other

Registry information

Important dates

Study start
2006
Study completion
2007
First posted
Oct 12, 2006
Registry last updated
Jun 5, 2007

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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