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An FDA phase I clinical trial of quinacrine sterilization (QS)
Author(s) -
Lippes J.,
Brar M.,
Gerbracht K.,
Neff P.,
Kokkinakis S.
Publication year - 2003
Publication title -
international journal of gynecology and obstetrics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.895
H-Index - 97
eISSN - 1879-3479
pISSN - 0020-7292
DOI - 10.1016/s0020-7292(03)90089-0
Subject(s) - medicine , clinical trial , ultrasound , clinical research , food and drug administration , surgery , scars , sterilization (economics) , pharmacology , radiology , monetary economics , economics , foreign exchange market , foreign exchange
Objective: To review the significance of a United States Food and Drug Administration (FDA) approved Phase I clinical trial of a new use for an old drug, quinacrine. To discover whether ultrasound may have utility in quinacrine sterilization (QS). Method: This clinical trial began on 16 September 2000 at the Women's and Children's Hospital of Buffalo (WCHOB) in Buffalo, New York. Ten patients volunteered to have QS. These subjects were carefully followed with regularly scheduled examinations, including extensive laboratory blood tests. In addition, each patient had a trans‐abdominal ultrasound examination six weeks or later past the date of the second insertion of quinacrine. The trial was completed on 30 April 2003. Results: Laboratory results fell within normal limits, thus providing additional evidence to affirm the lack of toxic effects of QS. With ultrasound, we were able to see scars in both oviducts on all of our patients. One patient with a small scar as seen on ultrasound became pregnant. Conclusion: QS was found to be safe and effective. Ultrasound holds the promise of reducing the failure rate.