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

Abortion, Induced Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00870272
• Other study ID #: 1.2.0
• Status: Completed
• Phase: N/A
• First received: March 26, 2009
• Last updated: March 26, 2009
• Start date: July 2007
• Est. completion date: March 2009

Study information

• Verified date: March 2009
• Source: Gynuity Health Projects
• Contact: n/a
• Is FDA regulated: No
• Health authority: Moldova: Municipal Hospital No. 1
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 550
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abortion, Induced

Intervention

Drug:
• Misoprostol
400mcg misoprostol taken sublingually or buccally

Locations

Country	Name	City	State
Moldova, Republic of	State University of Medicine and Pharmacy	Chisinau

Sponsors (1)

Lead Sponsor	Collaborator
Gynuity Health Projects

Country where clinical trial is conducted

Moldova, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of safety and efficacy of 2 different routes of misoprostol after mifepristone administration		July 2007-March 2009	Yes
Secondary	Side effects experienced		July 2007- March 2009	Yes