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Patient Profiles
CERAZETTE /
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Patient Profiles

Updated on 15/03/2018

CONTRACEPTION

Which of your patients could benefit from CERAZETTE® (desogestrel)?

Select a patient profile to find out why CERAZETTE may be a suitable contraceptive option.

Obesity

Jessica

Jessica is 32 years old and is currently taking a combined hormonal contraception (CHC). She has a body mass index (BMI) of 32 kg/m2 and has a family history of high cholesterol. Jessica is concerned about increased risks of myocardial infarction with CHC use.

Will an oestrogen-free contraceptive with efficacy comparable with a CHC be a better fit for Jessica?

CERAZETTE in obesity

UK Medical Eligibility Criteria (MEC) guidelines help clinicians decide what contraceptives they can safely recommend based on the medical conditions of patients in their care.

Progestogen-only pills (POPs) are a favourable option in women who are obese.1

Condition CHC POP
Obesity

a) ≥30-34 kg/m2 body mass index 2 1
b) ≥35 kg/m2 body mass index 3 1
UKMEC DEFINITION OF CATEGORY
CATEGORY 1 A condition for which there is no restriction for the use of the contraceptive method
CATEGORY 2 A condition where the advantages of using the method generally outweigh the theoretical or proven risks
CATEGORY 3 A condition where the theoretical or proven risks generally outweigh the advantages of using the method. The provision of a method requires expert clinical judgement and/or referral to a specialist contraceptive provider, since use of the method is not usually recommended unless other more appropriate methods are not available or not acceptable.
CATEGORY 4 A condition which represents an unacceptable health risk if the contraceptive method is used

CHC: combined hormonal contraception; POP: progestogen-only pill.

There is limited data on the efficacy and safety of CERAZETTE in women who are obese

  • CERAZETTE shows no clinically relevant effects on carbohydrate metabolism, lipid metabolism or haemostasis.1
  • Obesity may increase the risk of dyslipidaemia, coronary heart disease, diabetes or haemostatic abnormalities.3,4
  • No change from baseline in LDL-C and a small decrease in total cholesterol and triglycerides have been observed.5

Suffers from migraines

Karen

Karen is 27 years old and is currently on a combined hormonal contraceptive (CHC). She suffers from debilitating migraines and is concerned it may be due to her birth-control pill.

Is CERAZETTE an option for women who want to minimise issues associated with oestrogen?

UK Medical Eligibility Criteria (MEC) guidelines help clinicians decide what contraceptives they can safely recommend based on the medical conditions of patients in their care.

Progestogen-only pills (POPs) are a favourable option in women who suffer from migraines.1

Condition CHC POP
Headaches I C I C
a) Non-migrainous (mild or severe) 1 2 1 1
b) Migraine without aura, at any age 2 3 1 2
c) Migraine with aura, at any age 4 4 2 2
d) Past history (≥5 years ago) of migraine with aura, any age 3 3 2 2

C: continuation; I: initiation;

UKMEC DEFINITION OF CATEGORY
CATEGORY 1 A condition for which there is no restriction for the use of the contraceptive method
CATEGORY 2 A condition where the advantages of using the method generally outweigh the theoretical or proven risks
CATEGORY 3 A condition where the theoretical or proven risks generally outweigh the advantages of using the method. The provision of a method requires expert clinical judgement and/or referral to a specialist contraceptive provider, since use of the method is not usually recommended unless other more appropriate methods are not available or not acceptable.
CATEGORY 4 A condition which represents an unacceptable health risk if the contaceptive method is used

CHC: combined hormonal contraception; POP: progestogen-only pill.

CHCs are contraindicated in women who have migraines with aura.11,12

Cigarette smoker

Beth

Beth is 30 years old and has been smoking for over 12 years. She is currently taking an oral combined hormonal contraceptive (CHC) but she is concerned of increased risk of cardiac events.

Is there an oestrogen-free option that has been classified more favourably than CHCs for smokers?

UK Medical Eligibility Criteria (MEC) guidelines help clinicians decide what contraceptives they can safely recommend based on the medical conditions of patients in their care.

Progestogen-only pills (POPs) are a favourable option in women who are smokers.1

Condition CHC POP
Smoking

a) Age <35 years 2 1
b) ≥35 years

  (i) <15 cigarettes/day 3 1
  (ii) ≥15 cigarettes/day 4 1
  (iii) Stopped smoking <1 year ago 3 1
  (iv) Stopped smoking ≥1 year ago 2 1
UKMEC DEFINITION OF CATEGORY
CATEGORY 1 A condition for which there is no restriction for the use of the contraceptive method
CATEGORY 2 A condition where the advantages of using the method generally outweigh the theoretical or proven risks
CATEGORY 3 A condition where the theoretical or proven risks generally outweigh the advantages of using the method. The provision of a method requires expert clinical judgement and/or referral to a specialist contraceptive provider, since use of the method is not usually recommended unless other more appropriate methods are not available or not acceptable.
CATEGORY 4 A condition which represents an unacceptable health risk if the contaceptive method is used

CHC: combined hormonal contraception; POP: progestogen-only pill.

Breastfeeding

Lily

Lily is 24 years old and gave birth 2 months ago. She would like to resume taking contraception, however she is breastfeeding and is concerned that this may affect the quality of her breast milk.

Is CERAZETTE a suitable option for contraception while breastfeeding?

CERAZETTE does not affect quantity or quality of milk2,8

Based on the available data CERAZETTE may be used during lactation. The development and growth of a nursing infant, whose mother uses CERAZETTE, should, however, be carefully observed.2

UK Medical Eligibility Criteria (MEC) guidelines for contraceptive use1

Condition CHC POP
Breastfeeding

a) <6 weeks postpartum 4 1
b) ≥6 weeks to <6 months (fully or almost breastfeeding) 3 1
c) ≥6 weeks to <6 months postpartum (partial breastfeeding medium to minimal) 2 1
d) ≥6 months postpartum 1 1
UKMEC DEFINITION OF CATEGORY
CATEGORY 1 A condition for which there is no restriction for the use of the contraceptive method
CATEGORY 2 A condition where the advantages of using the method generally outweigh the theoretical or proven risks
CATEGORY 3 A condition where the theoretical or proven risks generally outweigh the advantages of using the method. The provision of a method requires expert clinical judgement and/or referral to a specialist contraceptive provider, since use of the method is not usually recommended unless other more appropriate methods are not available or not acceptable.
CATEGORY 4 A condition which represents an unacceptable health risk if the contaceptive method is used

CHC: combined hormonal contraception; POP: progestogen-only pill.

CERAZETTE does not influence the quantity of breast milk2

The effects of CERAZETTE and an IUCD on the quantity of breast milk (24-hour milk volume; mean values)8

Adapted from Bjarnadóttir et al, 2001.8 IUCD=intrauterine contraceptive device.

Study details

  • A single-centre, open, non-randomised, group-comparative study of women aged 18-40 years.
  • Participants were allowed to choose their own treatment: CERAZETTE 75 mcg/day or a Multiload Cu375 intrauterine device. Treatment was started at least 28 days but not more than 56 days postpartum. Treatment was continued for seven continuous 28-day cycles.
  • The children were followed up until they were 2.5 years.

CERAZETTE does not influence the quality of breast milk1

  • The breast milk in both groups had a similar triglyceride, protein and lactose content.8.

The effects of desogestrel and an IUCD on milk composition: lactose, protein and triglycerides concentrations (mean values and 95% confidence intervals).8

Adapted from Bjarnadóttir et al, 2001.8 IUCD=intrauterine contraceptive device.

Possible oestrogen-related side effects

Maria

Maria is 25 years old and has been taking a combined hormonal contraceptive (CHC) for 2 years. She suffers from headaches and breast tenderness which she notes started around the same time she began taking the CHC.

Can Maria switch to an oestrogen-free option to overcome her side effects without sacrificing efficacy?

After switching to CERAZETTE, most of the oestrogen-related symptoms completely disappeared (73%) or improved (92%).6

Changes in oestrogen-related side effects from study baseline to 3-4 months6

Study details6

  • A prospective, non-comparative, multicentre, observational study evaluating the effects of CERAZETTE in women with oestrogen-related symptoms during previous CHC use.
  • Women took CERAZETTE continuously for a period of three cycles (one cycle=28 days). Breast tension, nausea, oedema and headache were assessed at baseline and after 3-4 months, along with bleeding pattern and treatment satisfaction.
  • A total of 403 women who reported experiencing oestrogen-related symptoms during previous use of CHCs were included in the study.

Prefers not to use oestrogen-containing contraceptive

Tina

Tina is a 19-year-old student. She would like to start taking a contraceptive pill but would prefer not to take oestrogen as she is concerned about potential side effects.

Is there an oestrogen-free option with reliable efficacy?

Efficacy

Similar to combined oral contraceptives, CERAZETTE is 99% effective.2

CERAZETTE offers:

  • ovulation inhibition similar to that of CHCs7
  • flexibility with a missed pill window of 12 hours2

Safety profile: CERAZETTE improved oestrogen-related symptoms

Some women may prefer not to take an oestrogen-containing contraceptive because of the potential risks associated with extra oestrogen.

After switching to CERAZETTE, most of the oestrogen-related symptoms completely disappeared (73%) or improved (92%).6

Changes in oestrogen-related side effects from study baseline to 3-4 months6

Study details6

  • A prospective, non-comparative, multicentre, observational study evaluating the effects of CERAZETTE in women with oestrogen-related symptoms during previous CHC use.
  • Women took CERAZETTE continuously for a period of three cycles (one cycle=28 days). Breast tension, nausea, oedema and headache were assessed at baseline and after 3-4 months, along with bleeding pattern and treatment satisfaction.
  • A total of 403 women who reported experiencing oestrogen-related symptoms during previous use of CHCs were included in the study.

References

  1. Faculty of Sexual and Reproductive Health Care. UK Medical Eligibility Criteria for Contraceptive Use. May 2016. http://ukmec.pagelizard.com/2016.
  2. CERAZETTE Summary of Product Characteristics.
  3. Pomp E R, le Cessie S et al. Risk of venous thrombosis: obesity and its joint effect with oral contraceptive use and prothrombotic mutations. Br J Haematol 2007;139:289-296.
  4. American Heart Association (AHA). Obesity information. Available at: http://www.heart.org/HEARTORG/GettingHealthy/WeightManagement/Obesity/Obesity-Information_UCM_307908_Article.jsp.
  5. Barkfeldt J, Virkkunen A and Dieben T. The effects of two progestogen-only pills containing either desogestrel (75 microg/day) or levonorgestrel (30 microg/day) on lipid metabolism. Contraception 2001;64:295-299.
  6. Ahrendt H J, Karckt U et al. The effects of an oestrogen-free, desogestrel-containing oral contraceptive in women with cyclical symptoms: results from two studies on oestrogen-related symptoms and dysmenorrhoea. Eur J Contracept Reprod Health Care 2007;12:354-361.
  7. Milsom I and Korver T. Ovulation incidence with oral contraceptives: a literature review. J Fam Plann Reprod Health Care 2008;34:237-246.
  8. Bjarnadottir R I, Gottfredsdottir H et al. Comparative study of the effects of a progestogen-only pill containing desogestrel and an intrauterine contraceptive device in lactating women. BJOG 2001;108:1174-1180.
  9. Tanis B C, van den Bosch M A et al. Oral contraceptives and the risk of myocardial infarction. N Engl J Med 2001;345:1787-1793.
  10. Farley T M, Meirik O et al. Combined oral contraceptives, smoking, and cardiovascular risk. J Epidemiol Community Health 1998;52:775-785.
  11. MICROGYNON 30 Summary of Product Characteristics.
  12. YASMIN film-coated tablets Summary of Product Characteristics.

Supporting documentation

Prescribing Information | Summary of Product Characteristics | Patient Information Leaflet

WOMN-1247520-0000 | Date of Preparation: March 2018