An FDA phase I clinical trial of quinacrine sterilization (QS).
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).


METHODS
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.


CONCLUSIONS
QS was found to be safe and effective. Ultrasound holds the promise of reducing the failure rate.
Lippes
J
J
School of Medicine, State University of New York at Buffalo, Buffalo, New York, USA. jlip@acsu.buffalo.edu
Brar
M
M
Gerbracht
K
K
Neff
P
P
Kokkinakis
S
S
D000328:Adult; D002921:Cicatrix / Q000000981:diagnostic imaging*; D004343:Drug Implants; D005187:Fallopian Tubes / Q000000981:diagnostic imaging* / Q000187:drug effects*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008875:Middle Aged; D011247:Pregnancy; D011796:Quinacrine / Q000008:administration & dosage / Q000009:adverse effects*; D012102:Reproductive Control Agents / Q000008:administration & dosage / Q000009:adverse effects*; D013246:Sterilization, Tubal; D014463:Ultrasonography; D014481:United States; D014486:United States Food and Drug Administration
D004343:Drug Implants; D012102:Reproductive Control Agents; D011796:Quinacrine