Vaginal distribution of Replens and K-Y Jelly using three imaging techniques.
BACKGROUND
Determination of vaginal distribution is important to the development of potential vaginal microbicidal or spermicidal products.


METHODS
This was a descriptive study of three imaging techniques with a randomized crossover assignment of two gels and activity status within each technique.


METHODS
Each of three sites utilized one technique. Three nulligravid women and three parous women were to be enrolled at each site. We studied the effects of time, ambulation, parity and body mass index on vaginal spreading of two commonly used gels, K-Y Jelly and Replens. Imaging by magnetic resonance imaging and gamma scintigraphy was performed at 5, 20, 35 and 50 min after insertion of 3.5 mL of gel. Imaging with a fiberoptic probe was performed at 5 and 20 min after insertion.


RESULTS
Initial application of the gel resulted in approximately two thirds of maximum coverage possible, both in linear extent along the vaginal axis and in surface area covered. Over the next 45 min, spreading increased to about three quarters of the maximum possible. Ambulation generally increased linear spreading and the proportions of women with gel at the introitus and os. Effects of parity and body mass index (BMI) were similar on most measures of gel spreading, with nulligravid women tending toward greater spread than parous women and women of high BMI usually showing somewhat greater spread than women of normal weight. Differences between the two gels were not seen when all conditions of application were considered together.


CONCLUSIONS
In vivo imaging of gel distribution demonstrated that ambulation, parity and BMI affect vaginal gel spreading. The three imaging techniques have advantages and disadvantages and provide complementary information for microbicide development.
Mauck
Christine K
CK
CONRAD, Eastern Virginia Medical School, Arlington, VA 22209, USA. cmauck@conrad.org
Katz
David
D
Sandefer
Erik P
EP
Nasution
Marlina D
MD
Henderson
Marcus
M
Digenis
George A
GA
Su
Irene
I
Page
Richard
R
Barnhart
Kurt
K
D000282:Administration, Intravaginal; D000328:Adult; D015992:Body Mass Index; D002482:Cellulose / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000493:pharmacokinetics; D003127:Colposcopy / Q000379:methods; D018592:Cross-Over Studies; D004643:Emollients / Q000008:administration & dosage / Q000493:pharmacokinetics*; D005260:Female; D005336:Fiber Optic Technology; D005990:Glycerol / Q000008:administration & dosage / Q000493:pharmacokinetics*; D006801:Humans; D008055:Lipids / Q000008:administration & dosage / Q000493:pharmacokinetics; D008279:Magnetic Resonance Imaging; D010298:Parity; D010710:Phosphates / Q000008:administration & dosage / Q000493:pharmacokinetics*; D011247:Pregnancy; D011409:Propylene Glycols / Q000008:administration & dosage / Q000493:pharmacokinetics*; D011877:Radionuclide Imaging; D013997:Time Factors; D014018:Tissue Distribution; D014621:Vagina / Q000000981:diagnostic imaging / Q000378:metabolism*; D014622:Vaginal Creams, Foams, and Jellies / Q000493:pharmacokinetics; D016138:Walking
D004643:Emollients; C042973:K-Y jelly; D008055:Lipids; D010710:Phosphates; D011409:Propylene Glycols; C085472:Replens; D014622:Vaginal Creams, Foams, and Jellies; D002482:Cellulose; D005990:Glycerol