CERAZETTE^® (desogestrel) – Safety and Tolerability

A large-scale study (n=1,306) compared the contraceptive efficacy, bleeding pattern, acceptability and safety of CERAZETTE to a progestogen-only pill containing 30 mcg of levonorgestrel.¹

Compared to women in the levonorgestrel group, women in the CERAZETTE group tended to experience less bleeding over time, though the bleeding pattern showed more variability.¹

Additionally, there was more amenorrhoea and more infrequent bleeding over time in the CERAZETTE group.¹

There was a shift towards less bleeding and/or spotting days with CERAZETTE than with levonorgestrel.¹

Frequent or prolonged bleeding¹

Adapted from Collaborative Study Group on the Desogestrel-containing Progestogen-Only Pill, 1998¹

*Shifted reference period (days 29-118)
^†Does not include breastfeeding participants
22.5% of participants discontinued treatment with CERAZETTE before cycle 1 due to irregular bleeding.
Discontinuation continued throughout the study.

Amenorrhoea and infrequent bleeding¹

Adapted from Collaborative Study Group on the Desogestrel-containing Progestogen-Only Pill, 1998¹

*Shifted reference period (days 29-118)
^†Does not include breastfeeding participants

Study details¹

• A double-blind, randomised, group-comparative, multicentre trial to compare the contraceptive efficacy, bleeding pattern, acceptability and safety of CERAZETTE to levonorgestrel.
• 1,320 subjects aged 18-40 years were randomised to CERAZETTE 75 mcg/day (n=989) or levonorgestrel 30 mcg/day (n=331).
• The participants were observed for 13 consecutive treatment periods of 28 days. Bleeding pattern indices, were defined using Reference Period Analysis. The incidence of these indices were compared between treatments at the 90-day reference period that started 28 days after taking the initial tablet, using the intent-to-treat group.

Safety information

The most commonly reported undesirable effects associated with CERAZETTE are bleeding changes,² which are common to any method of progestogen-only contraception.³ Counselling women to expect changes in their bleeding pattern with progestogen-only contraception may increase their likely acceptance of the bleeding pattern.²

References

1. A double-blind study comparing the contraceptive efficacy, acceptability and safety of two progestogen-only pills containing desogestrel 75 micrograms/day or levonorgestrel 30 micrograms/day. Collaborative Study Group on the Desogestrel-containing Progestogen-only Pill. Eur J Contracept Reprod Health Care 1998;3:169-178.
2. CERAZETTE Summary of Product Characteristics.
3. NORIDAY Tablets Summary of Product Characteristics.

Supporting documentation

Prescribing Information | Summary of Product Characteristics | Patient Information Leaflet

WOMN-1247519-0000 | Date of Preparation: March 2018