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Study of Sublingual Versus Oral Misoprostol Administration Following Mifepristone 200 mg for Abortion up to 63 Days Gestation
This study has been completed.
Sponsor:
Gynuity Health Projects
Information provided by (Responsible Party):
Gynuity Health Projects
ClinicalTrials.gov Identifier:
NCT00286208
First received: February 1, 2006
Last updated: February 18, 2014
Last verified: February 2014
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Purpose
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 | Intervention |
|---|---|
| Induced Abortion | Drug: Mifepristone, misoprostol |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
| Official Title: | A Randomized Study of Sublingual Versus Oral Misoprostol Administration Following Mifepristone 200 mg for Abortion up to 63 Days Gestation |
Resource links provided by NLM:
Further study details as provided by Gynuity Health Projects:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- Side effects [ Time Frame: 48 hours ]
- Acceptability for women [ Time Frame: 2 weeks ]
| Enrollment: | 1443 |
| Study Start Date: | August 2005 |
| Study Completion Date: | January 2008 |
| Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Sublingual Misoprostol
400 mcg of sublingual misoprostol
|
Drug: Mifepristone, misoprostol |
|
Active Comparator: Oral Misoprostol
Misoprostol administered orally
|
Drug: Mifepristone, misoprostol |
Eligibility| Ages Eligible for Study: | Child, Adult, Senior |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Women presenting for medical abortion who consent to participate
- Possibility of final gestational age of less than or equal to 63 days
- General good health
- Willing to provide contact information 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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00286208
Please refer to this study by its ClinicalTrials.gov identifier: NCT00286208
Locations
| Moldova, Republic of | |
| State University of Medicine and Pharmacy | |
| Chisinau, Moldova, Republic of | |
| Tunisia | |
| Centre de Planification Familiale de l'Ariana | |
| Ariana, Tunisia | |
| Centre de Planification Familiale la Bardo | |
| Tunis, Tunisia | |
| Maternité de La Rabta | |
| Tunis, Tunisia | |
| Private clinic | |
| Tunis, Tunisia | |
| Turkey | |
| Dr. Zekai Tahir Burak Women's Health Training and Research Hospital | |
| Ankara, Turkey | |
| MoH Ankara Etlik Maternity and Gyneacological Training Hospital | |
| Ankara, Turkey | |
| Haydarpaşa Numune Training and Research Hospital Family Planning Clinic | |
| Istanbul, Turkey | |
| Ege Maternity and Gyneacological Training and Research Hospital | |
| Izmir, Turkey | |
Sponsors and Collaborators
Gynuity Health Projects
Investigators
| 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 |
More Information
| Responsible Party: | Gynuity Health Projects |
| ClinicalTrials.gov Identifier: | NCT00286208 History of Changes |
| Other Study ID Numbers: |
1.1.5 |
| Study First Received: | February 1, 2006 |
| Last Updated: | February 18, 2014 |
Keywords provided by Gynuity Health Projects:
|
Medical abortion mifepristone misoprostol |
Additional relevant MeSH terms:
|
Misoprostol Mifepristone Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents Physiological Effects of Drugs Anti-Ulcer Agents Gastrointestinal Agents Oxytocics Abortifacient Agents, Steroidal |
Contraceptives, Oral, Synthetic Contraceptives, Oral Contraceptive Agents, Female Contraceptive Agents Contraceptives, Postcoital, Synthetic Contraceptives, Postcoital Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Luteolytic Agents Menstruation-Inducing Agents |
ClinicalTrials.gov processed this record on August 18, 2017