Pregnancy: There is limited data from the use of dienogest in pregnant women.
Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions).
ENDOVELLE must not be administered to pregnant women because there is no need to treat endometriosis during pregnancy.
Lactation: Treatment with ENDOVELLE during lactation is not recommended.
It is unknown whether dienogest is excreted in human milk. Data in animals have shown excretion of dienogest in rat milk.
A decision must be made whether to discontinue breast-feeding or to abstain from ENDOVELLE 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. However, ENDOVELLE is not a contraceptive.
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 ENDOVELLE.