Pregnancy: ENDOMETRIN vaginal tablets are only indicated during the first trimester of pregnancy for use as part of an assisted reproduction (ART) regimen.
There is yet limited and inconclusive data on the risk of congenital anomalies, including genital abnormalities in male or female infants, following intrauterine exposure during pregnancy.
In the pivotal trial, the rate of foetal anomalies following 10-week exposure to ENDOMETRIN 100 mg three times daily was 4.5% in the ENDOMETRIN three times daily group, a total of 7 cases of foetal anomalies (i.e. oesophageal fistula, underdeveloped right ear with hypospadias, small aorta/ valvular regurgitation/ deviated septum, hand deformity, cleft palate/cleft lip, hydrocephalus and holoprosencephaly/ proboscis/ polydactylia) were seen in 404 patients. The rate of foetal anomalies observed during the clinical trial is comparable with the event rate described in the general population, although the total exposure is too low to allow conclusions to be drawn.
During the conduct of the pivotal clinical trial, the number of spontaneous abortions and ectopic pregnancies associated with the use of ENDOMETRIN 100 mg three times daily were 5.4% and 1%, respectively.
Lactation: Detectable amounts of progesterone have been identified in the milk of mothers. Therefore ENDOMETRIN should not be used during lactation.