Pregnancy & Lactation : הריון/הנקה

4.6   Fertility, pregnancy and lactation
Pregnancy
It is estimated that over 9 million women have already been exposed to dydrogesterone during pregnancy. To date there were no indications that the use of dydrogesterone during pregnancy has a harmful effect. In the literature a study is described in which it was found that the use of some progestogens can be accompanied by an increase in the risk of hypospadia occurring. However, because this has not been clearly confirmed to date in other studies, no final conclusion can be drawn about the effect of progestogens on the occurrence of hypospadia.

Clinical trials in which a limited number of women were treated with dydrogesterone in the first stage of pregnancy did not show that the risk is increased. To date no other epidemiological data are available.

The effects that were observed during non-clinical study into embryo-foetal and postnatal development corresponded with the pharmacological profile. Unwanted effects only occurred in case of exposure that was considerably higher than the maximum exposure in humans (see section 5.3).

Dydrogesterone may be administered during pregnancy if there is a clear indication for this.

Lactation
It is not known whether dydrogesterone is excreted in breast milk. No research has been done into the excretion of dydrogesterone in breast milk. Experiences with other progestogens indicate that progestogens and their metabolites are found in small quantities in breast milk.
It is not known whether there is a risk for the child. Dydrogesterone should therefore not be used while breastfeeding.

Fertility
There are no data on the effect of dydrogesterone on fertility.