Pregnancy: There are limited data from the use of dienogest in pregnant women. Animal studies and data from women exposed to dienogest during pregnancy reveal no special risks on pregnancy, embryonic/fetal development, birth or development after birth for humans (see also Pharmacology: Toxicology: Preclinical safety data under Actions). However, Dienogest (Vinca) should not be administered to pregnant women because there is no need to treat endometriosis during pregnancy.
Lactation: Treatment with Dienogest (Vinca) during lactation is not recommended. Physicochemical properties and animal data indicate excretion of dienogest in breast milk. A decision must be made whether to discontinue breast-feeding or to abstain from Dienogest (Vinca) therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Fertility: Based on the available data, ovulation is inhibited in the majority of patients during treatment with Dienogest (Vinca). However, Dienogest (Vinca) is not a contraceptive.
Dienogest (Vinca) was not studied for contraceptive efficacy, but DNG 2 mg has been shown in a study involving 20 women to inhibit ovulation after 1 month of treatment.
If contraception is required a non-hormonal method should be used (See Dosage & Administration).
Based on available data, the menstrual cycle returns to normal within 2 months after cessation of treatment with Dienogest (Vinca).
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