A Phase 4 interventional study of medical abortion in Complete Abortion, sponsored by Gynuity Health Projects. Completed at 2 sites in 2 countries. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-07-20.
Sponsored by Gynuity Health Projects · Phase 4, Interventional, and Treatment
This double blinded, placebo-controlled randomized trial will compare the safety, efficacy and acceptability of two medical abortion regimens up to 63 days since last Menstrual Period (LMP) in Tunisia and Vietnam. The first regimen will include a 200 mg oral dose of mifepristone followed by 800 mcg buccal misoprostol. The second regimen will include two 800 mcg doses of buccal misoprostol three hours apart. All drugs are administered AT home by the participant.
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.
Exclusion Criteria:
200 mg mifepristone + 800 mcg buccal misoprostol
Drug: medical abortion
2 doses of 800 mcg buccal misoprostol
Drug: medical abortion
pregnancy termination with drugs
Number of women with a complete abortion using study drug alone without recourse to surgical intervention
Number of participants with a complete abortion after treatment without recourse to surgical intervention as a measure of efficacy of the study regimens
Time frame: one week from initial treatment
Number of women who indicate that the side effects of buccal misoprostol, administered either alone or in combination with mifepristone, is acceptable in Tunisia and Vietnam
Proportion of women who report the side effects after their treatment to be acceptable as a measure of acceptability with the buccal misoprostol route (with and without mifepristone)
Time frame: one week from initial treatment
Evaluate whether women administering buccal misoprostol have a complete abortion with study drug and experience any adverse events, at a rate that is similar to other routes of misoprostol administration
To assess the rate of complete uterine evacuation with study drugs alone and rate of any adverse events among participants after use of buccal misoprostol (alone or with mifepristone)as a measure of its utility in early medical abortion compared to other regimens
Time frame: one week from initial treatment
Measuring the proportion of women who report their medical abortion procedure to be acceptable in Tunisia and Vietnam
Proportion of participants reporting that they found the medical abortion regimen assigned to them to be acceptable
Time frame: one week from initial treatment
Determining whether women can take both the mifepristone and misoprostol at home on their own by assessing protocol compliance
Proportion of women who report taking mifepristone and misoprostol at home on their own as instructed as a measure of compliance and feasibility of a protocol with at home administration of study drugs
Time frame: one week from initial treatment
This study is completed, as verified in Jul 2011. You cannot join it, but the record below documents what was studied.
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Gynuity Health Projects