A new gel for intracervical application of prostaglandin E2.
A new gel-formulation for intracervical application of prostaglandin E2 (PGE2) has been prepared. As a vehicle for the gel a cross-link starch polymer is used. PGE2 substance is added to the starch polymer and after homogenization and lyophilization a PGE2 powder is obtained. The powder can be stored at room temperature for more than four months without inactivation of the prostaglandin. Before clinical application a few ml of saline is added to the powder giving, within 30 seconds, an easily-handled ready to use PGE2-gel. Chemical analysis by spectrophotometric technique reveals that the amount of unchanged PGE2 is the same in the new gel-formulation as in a conventional cellulose gel. In a randomized double-blind study the new PGE2-gel was intracervically applied to twenty nulliparae before abortion by dilatation and evacuation (D & E). Ten women were given a gel containing 0.25 mg PGE2 (PGE2-gel) and ten a gel without PGE2 (placebo gel). It was found that the PGE2-gel, in contrast to the placebo gel, produced a rapid ripening of the cervix facilitating the subsequent D & E. No adverse systemic or local reactions were found during or after the treatment.
D000028:Abortion, Induced / Q000379:methods*; D000293:Adolescent; D000328:Adult; D002584:Cervix Uteri; D002986:Clinical Trials as Topic; D004107:Dilatation and Curettage; D004311:Double-Blind Method; D004341:Drug Evaluation; D004355:Drug Stability; D005260:Female; D005782:Gels; D006801:Humans; D011247:Pregnancy; D011458:Prostaglandins E / Q000008:administration & dosage*
D005782:Gels; D011458:Prostaglandins E