Study of 400mcg Versus 800mcg Buccal Misoprostol Following Mifepristone 200mg for Abortion up to 63 Days Gestation

Induced Abortion Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00482209
• Other study ID #: 1.1.6
• Status: Completed
• Phase: N/A
• First received: June 4, 2007
• Last updated: October 9, 2009
• Start date: May 2007
• Est. completion date: October 2009

Study information

• Verified date: October 2009
• Source: Gynuity Health Projects
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This double-blind, randomized study will compare the efficacy and acceptability of mifepristone 200mg followed in 36-48 hours by 400mcg or 800mcg of buccal misoprostol (i.e., in the cheeks) for termination of pregnancy in women up to 63 days LMP.

Description:

The goal of this study is to provide answers to the following four questions:

1. Is a regimen of medical abortion with mifepristone using 400mcg buccal misoprostol as effective and acceptable as using 800mcg buccal misoprostol up to 63 days since the last menstrual period (LMP)?

2. Are the side effects with buccal use tolerable for women?

3. Is buccal administration of misoprostol acceptable to women?

4. When given a choice, do women prefer to take misoprostol at home or in the clinic?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1220
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Women 18 years or over presenting for abortion services who consent to participate

• good general health

• assessed by a clinician to have an intrauterine pregnancy less than 64 days LMP on Study Day 1 and to be eligible for medical abortion

• Have ready access to a telephone and emergency transportation;

• Be willing to provide an address and/or telephone number for purposes of follow-up

Exclusion Criteria:

• Conditions which contraindicate the use of mifepristone or misoprostol

• Women presenting for medical abortion who do not consent to participate

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Induced Abortion

Intervention

Drug:
• Mifepristone, misoprostol
200mg mifepristone followed by 400mcg misoprostol 36-48 hours later
• mifepristone, misoprostol
200mg mifepristone followed by 800mcg misoprostol 36-48 hours later

Locations

Country	Name	City	State
Georgia	Maternity House #2	Tbilisi
Georgia	Maternity House #4	Tbilisi
Georgia	Zhordania Institute of Human Reproduction	Tbilisi
Vietnam	Hocmon Hospital	Ho Chi Minh City

Sponsors (1)

Lead Sponsor	Collaborator
Gynuity Health Projects

Countries where clinical trial is conducted

Georgia,  Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Need for surgical completion for ongoing viable pregnancies at follow up visit (Study day 12-15) or for incomplete abortion at extended follow up visit (Study day (19-22).		Study day 12-15 for ongoing viable pregnancies or Study day 19-22 for incomplete abortion at extended follow up visit	No
Secondary	Side-effects, acceptability for women		side effects and acceptability recorded at exit interview	No

External Links

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