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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00386867 |
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Date of registration:
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10/10/2006 |
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Primary sponsor: |
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Public title:
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A Randomized Trial of Buccal Compared to Oral Misoprostol Following Mifepristone for Medical Abortion up to 63 Days LMP
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Scientific title:
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Date of first enrolment:
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October 2006 |
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Target sample size:
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1200 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00386867 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Beverly Winikoff, MD, MPH |
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Address:
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Telephone:
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Email:
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Affiliation:
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Gynuity Health Projects |
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Name:
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Ilana Dzuba, MHS |
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Address:
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Telephone:
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Email:
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Affiliation:
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Gynuity Health Projects |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- be willing and able to sign consent forms;
- be eligible for medical abortion according to clinician’s assessment;
- be willing to undergo a surgical completion if necessary;
- have ready and easy access to a telephone and emergency transportation;
- speak English, Spanish, or have a translator available to translate for all study
procedures; and,
- agree to comply with the study procedures and visit schedule.
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 therapy;
- Inherited porphyrias; or
- Other serious physical or mental health conditions.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Abortion, Induced
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Intervention(s)
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Drug: 800 mcg misoprostol via oral or buccal administration
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Primary Outcome(s)
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efficacy
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Secondary Outcome(s)
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acceptability
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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