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Clogesten Cream Pregnancy |
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Pregnancy predisposes patients to the development of vaginal candidiasis due to changes in the vaginal tract. Clogesten Cream has been used in several clinical trials for the treatment of vaginal candidiasis during the second and third trimester without evidence of fetal harm. One trial included 57 patients in their first trimester. Again no adverse effects were attributed to Clogesten Cream. In a review of 229,101 deliveries to Michigan Medicaid patients, 2624 first-trimester exposures to Clogesten Cream and 8590 exposures any time during pregnancy were recorded. A total of 118 birth defects were reported with first trimester exposure (112 expected) and included (observed/expected) 27/26 cardiovascular defects, 3/1 spina bifida, 4/4 oral clefts, 9/6 polydactyly, 1 limb reduction, and 6/6 hypospadias. (written communication, Franz Rosa, MD, Food and Drug Administration, 1994) These data do not support an association between first-trimester Clogesten Cream use and birth defects.
Clogesten Cream has been assigned to pregnancy category C by the FDA when given as oral troches, and pregnancy category B when used intravaginally or topically. Animals given high doses intravaginally and orally have not shown evidence of teratogenicity. In clinical trials involving women in their second and third trimester, Clogesten Cream treatment of vaginal candidiasis has not been associated with fetal harm. Clogesten Cream use has not been well studied during the first trimester. Clogesten Cream is only recommended for use during pregnancy when benefit outweighs risk.
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There are no data on the excretion of Clogesten Cream into human milk.
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Information checked by Dr. Sachin Kumar, MD Pharmacology
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