Study of Sublingual Versus Oral Misoprostol Administration Following Mifepristone 200 mg for Abortion up to 63 Days Gestation
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|ClinicalTrials.gov Identifier: NCT00286208|
Recruitment Status : Completed
First Posted : February 3, 2006
Last Update Posted : February 19, 2014
This open-label, randomized study is being conducted to determine whether a dose of 400 mcg of sublingual misoprostol (i.e., under the tongue) taken 24 hours following administration of mifepristone 200 mg is effective and acceptable at inducing an abortion compared with misoprostol taken orally.
The goal of this study is to provide answers to the following four questions:
- Is a regimen of medical abortion with mifepristone using sublingual misoprostol at least as effective as using oral misoprostol up to 63 days since the last menstrual period (LMP)?
- Are the side effects with sublingual use tolerable for women?
- Is sublingual administration of misoprostol acceptable to women?
- Is one of the regimens (sublingual or oral) superior in terms of efficacy, safety (side-effects) or acceptability?
|Condition or disease||Intervention/treatment||Phase|
|Induced Abortion||Drug: Mifepristone, misoprostol||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1443 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Study of Sublingual Versus Oral Misoprostol Administration Following Mifepristone 200 mg for Abortion up to 63 Days Gestation|
|Study Start Date :||August 2005|
|Actual Primary Completion Date :||January 2008|
|Actual Study Completion Date :||January 2008|
Active Comparator: Sublingual Misoprostol
400 mcg of sublingual misoprostol
Drug: Mifepristone, misoprostol
Active Comparator: Oral Misoprostol
Misoprostol administered orally
Drug: Mifepristone, misoprostol
- Need for surgical completion for incomplete abortions or ongoing viable pregnancies at follow up visit Study day 15. [ Time Frame: 2 weeks after mifepristone administration ]
- Side effects [ Time Frame: 48 hours ]
- Acceptability for women [ Time Frame: 2 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00286208
|Moldova, Republic of|
|State University of Medicine and Pharmacy|
|Chisinau, Moldova, Republic of|
|Centre de Planification Familiale de l'Ariana|
|Centre de Planification Familiale la Bardo|
|Maternité de La Rabta|
|Dr. Zekai Tahir Burak Women's Health Training and Research Hospital|
|MoH Ankara Etlik Maternity and Gyneacological Training Hospital|
|Haydarpaşa Numune Training and Research Hospital Family Planning Clinic|
|Ege Maternity and Gyneacological Training and Research Hospital|
|Study Director:||Sheila Raghavan, M.Sc.||Gynuity Health Projects|
|Principal Investigator:||Beverly Winikoff, MD, MPH||Gynuity Health Projects|
|Study Director:||Rasha Dabash, MPH||Gynuity Health Projects|
|Principal Investigator:||Selma Hajri, MD||Reproductive Health Consultant|
|Principal Investigator:||Ayse Akin, MD, MPH||Baskent University|
|Study Director:||Ilana Dzuba, MHS||Gynuity Health Projects|