Contraception for women aged 40 and over

Despite fertility naturally declining with age, women require effective contraception until menopause in order to avoid unplanned pregnancies. Although there is a trend towards women having children later in life, there are also a number of unplanned pregnancies in women over 40 and the abortion rate for this group of women continues to rise (Department of Health and Social Care, 2018). For women over 40, pregnancy is associated with higher rates of maternal morbidity and mortality, significantly increased rates of miscarriage and ectopic pregnancy, and increased rates of pre-term delivery, stillbirth, perinatal mortality and congenital anomalies (Faculty of Sexual and Reproductive Healthcare (FSRH), 2017a).

As with all women, a contraceptive discussion needs to take into consideration a woman's medical history, personal preferences and any non-contraceptive benefits; but women aged over 40 have additional considerations. Due to increasing morbidity with age, background risks are higher than for younger women and so contraceptive safety profiles also differ.

Coupled with this, as women approach menopause and ovulation becomes irregular, they may experience symptoms related to fluctuating hormone levels, which may be masked or alleviated by hormonal contraception. As a result, contraception is associated with different risks and benefits for women aged over 40 and healthcare practitioners should be familiar with these in order to help women choose the most appropriate method of contraception for their needs. Assessment of the safety of a method should be considered in consultation with the most current FSRH United Kingdom Medical Eligibility Criteria (UKMEC) (FSRH, 2016) and the FSRH Guideline Contraception for Women Age Over 40 (FSRH, 2017a).

Perimenopause

Menopause is defined as the last menstrual period (LMP); a diagnosis which can only be made retrospectively following one year of amenorrhoea or 2 years if under 50. The diagnosis is usually made clinically, and most women do not require serum hormone testing to confirm it (National Institute for Health and Care Excellence (NICE), 2015). Once post-menopausal, ovarian function ceases and natural fertility is no longer possible. The average age of natural menopause in the UK is 52 years old, however, there is a transitional phase known as perimenopause, which precedes the LMP and lasts on average between 4-5 years (FSRH, 2017a).

Perimenopause is characterised by dramatic fluctuations in hormone levels; variable ovarian function with fewer ovulatory cycles; and, frequently, changes in menstrual bleeding patterns. Clinical features associated with declining oestrogen levels, such as vasomotor symptoms, may also present during this time. While anovulatory cycles are more common in the years preceding the menopause, ovulation does still occur and therefore pregnancy is still possible. For women who are not intending to become pregnant, contraception should be continued until post-menopausal status (and therefore absence of fertility) is confirmed. The advice regarding discontinuation of contraception will be individualised, depending on the current method used, and how and when menopause is confirmed.

Current FSRH recommendations are summarised in Table 1. Due to the extreme fluctuations in hormone levels during perimenopause, measurement of follicle-stimulating hormone (FSH) levels is generally restricted to those over 50 years who are amenorrhoeic. For women over 50 years who are using progestogen-only contraception (POC) and are keen to stop, FSH levels may be checked, and if raised (more than 30mIU/ml), contraception can be discontinued after a further one year (FSRH, 2017a).

Contraception and hormone replacement therapy

The relative lack of ovarian oestrogen production in perimenopause and beyond can lead to a variety of physical and psychological symptoms, such as hot flushes, night sweats, mood changes, low libido, urinary frequency and vaginal dryness. These symptoms can negatively impact quality of life and there are a number of medical and non-medical management options available (NICE, 2015). Some women may choose to use hormone replacement therapy (HRT), which is licensed for the treatment of menopausal symptoms.

In basic terms, HRT involves replacing oestrogen in an attempt to reduce severity/prevalence of symptoms. The levels of oestrogen in HRT are much lower than in combined hormonal contraception (CHC), and are nonsynthetically derived, usually in the form of oestradiol. However, the oestrogen component must be given alongside a form of progestogen, to reduce the risk of abnormal endometrial proliferation and malignancy in women who still have their uterus. This can be administered on either a continuous or ‘sequential’ (cyclical) basis (NICE, 2017).

Women may commence HRT either before or after their LMP, depending on the onset and severity of their symptoms. If HRT is used by premenopausal women (such as before the LMP), fertility and pregnancy risk should be considered. For premenopausal women with an intact uterus, a sequential HRT regimen is usually advised (NICE, 2017). While some HRT regimens (particularly those which include continuous progestogen administration) are theoretically likely to prevent ovulation and successful implantation, there is inadequate evidence to support this and, as such, HRT should not be relied upon to provide contraception.

Therefore, for sexually-active premenopausal women using HRT, an additional method of contraception should be used to prevent unintended pregnancy. The exception to this is when the Mirena IUS is used to provide endometrial protection (along with systemic oestrogen), as this will simultaneously provide highly-effective contraception (FSRH, 2017a). The safety and role of specific methods in conjunction with HRT are summarised in Table 2.

It should be noted that other types of IUS with lower levels of levonorgestrel (such as Jaydess or Kyleena) are not currently licensed for use as part of HRT and, as such, women using these for contraception should be advised either to use an additional progestogen for adequate endometrial protection, or to switch to the Mirena IUS. When Mirena is used as part of HRT, it should be replaced every 5 years to ensure adequate endometrial protection, regardless of the age at which it was inserted. This differs from the advice for women using it only for contraception, where it can be retained for up to 10 years (or until age 55) if inserted at or after the age of 45 years (see Table 3).

Due to its oestrogen content, CHC may also present an alternative to standard HRT for managing menopausal symptoms as well as providing contraception and may be used by suitable women until the age of 50, following a full clinical assessment (FSRH, 2017a). Prescribers are advised to refer to the most up-to-date version of the UKMEC to determine suitability of this method in individual circumstances (FSRH, 2016).

Once postmenopausal status is confirmed, women are no longer fertile and contraception can be discontinued (Table 1). However, as menopausal symptoms can persist for many years beyond the LMP, women may choose to continue with HRT. Once endogenous ovarian activity has ceased, women previously using sequential HRT should switch to a continuous HRT regimen, as it is associated with a lower risk of endometrial malignancy (NICE, 2015).

Method-specific guidance

Copper Intrauterine Device

As the copper intrauterine device (Cu IUD) does not contain any hormones, it does not affect the frequency or regularity of periods. Some women may find this advantageous, as they will be aware of when their periods stop. However, the Cu IUD can cause periods to become prolonged, heavier or more painful, which may be particularly problematic in perimenopause, a time when periods are often heavy and erratic.

Although most Cu IUDs in the UK are licensed for 5 or 10 years, the FSRH supports extended use of a Cu IUDs in women over 40. A Cu IUD fitted when a woman is age ≥40 can remain in situ until contraception is no longer required – 2 years after LMP if <50, or 1 year after LMP if >50 (FSRH, 2017a).

Levonorgestrel Intrauterine System

Problematic periods, including irregular, painful and/or heavy menstrual bleeding (HMB) are more common in women >40 (FSRH, 2017a) and therefore the bleeding profile of an LNG. Therefore, the bleeding profile of a levonorgestrel intrauterine systems (LNG-IUS) may be of particular benefit to women in this age group

IUS may be of particular benefit to women in this age group. All levonorgestrel intrauterine systems (LNG-IUS) reduce menstrual loss over time, with the 52mg LNG-IUS more commonly causing amenorrhoea than the 13.5 mg or 19 mg IUS (Gemzell-Danielsson, 2012). There are currently two 52 mg LNG IUS available in the UK – Mirena and Levosert. Both of these are recommended treatments for HMB (NICE, 2018), and licensed for HMB as well as contraception.

The Mirena is licensed for use for contraception for 5 years, however, extended use of a Mirena IUS is supported by the FSRH (Table 3). They advise that if a woman is age ≥45 at the time of insertion, she can rely on this for contraception until the age of 55, at which time she no longer requires contraception (FSRH, 2017a). An additional non-contraceptive benefit of Mirena is that it can be used as endometrial protection for women using HRT. Although the license for this use is 4 years, FSRH supports the use of a Mirena for endometrial protection for up to 5 years, regardless of the age at which it was inserted (FSRH, 2017a). Extended use of other LNG-IUS is not currently supported by the FSRH.

Combined hormonal contraception

CHC encompasses combined oral contraceptive pills, vaginal ring and transdermal patch. CHC confers a number of non-contraceptive benefits of particular relevance to women >40; but conversely a number of the risks associated with CHC are of increased significance in these women.

CHC has been shown to have a positive effect on bone mineral density and can alleviate symptoms of perimenopause, such as HMB, irregular bleeding and vasomotor symptoms (FSRH, 2017a). For these reasons, CHC can be used as an alternative to HRT in eligible women. Tailored regimens that reduce the number of hormone-free intervals (and withdrawal bleeds) may be particularly beneficial. Examples would be continuous use or the flexible extended regimen (Table 4), where women use CHC continuously (for at least 21 days) until they have 3-4 days of consecutive breakthrough bleeding, at which time they stop for a 4-7 days hormone free interval and then restart (FSRH, 2018). CHC has also been shown to reduce the risk of endometrial and ovarian cancers, with the protective effects lasting for many years after ceasing CHC use (FSRH, 2018).

In contrast, CHC is associated with a small increased risk of breast cancer, the incidence of which increases with age (FSRH, 2018). The prevalence of obesity and cardiovascular disease also increases with age and, in particular, the risk of venous thromboebolism (VTE) rises steeply over the age of 40. As higher doses of oestrogen (>30mcg) and newer progestogens confer the highest risk of VTE (9-12 per 10 000 healthy women per year), a COC preparation containing >30mcg ethinylestradiol combined with levonorgestrel should be prescribed as these confer the lowest VTE risk (5-7 per 10 000 healthy women per year) (FSRH, 2017a). Other risk factors such as obesity, smoking, family and personal history of cardiovascular disease also need to be considered, in line with UKMEC.

The FSRH recommends that women over 40 using CHC should be encouraged to consider alternative methods of contraception and should switch to a safer method of contraception by the age of 50, when the risks of using CHC for contraception outweigh the benefits.

Women who wish to continue use beyond the age of 50 due to non-contraceptive benefits should be considered on an individual basis. Women who smoke should not use CHC beyond the age of 34, due to the increased risk of cardiovascular disease.

Progestogen-only implant

The progestogen-only implant (POI) is licensed for 3 years for contraception and extended use (>3 years in situ) is currently not recommended, regardless of the age at which it is inserted. It has no upper age limit for use and can be used until contraception is no longer required.

A benefit for women aged 40 and over is that it is not associated with increased risk of cardiovascular disease or any significant effect on bone mineral density (FSRH, 2017a). It can also alleviate menstrual and ovulatory pain; however, it is associated with an unpredictable bleeding pattern, which some women may find unacceptable (FSRH, 2014).

The POI cannot be used as endometrial protection.

Progestogen-only injectable contraception

Depot medroxyprogesterone acetate (DMPA) inhibits ovulation and often causes amenorrhoea, which can be of benefit to women with dysmenorrhoea or HMB (FSRH, 2017a). However, it is also associated with a small loss in bone mineral density, which may be of particular relevance to women over 40. Reassuringly, although women using DMPA experience an initial loss in bone mineral density, studies have not demonstrated that this is repeated or worsened by menopause (FSRH, 2017a). In spite of this, women over 40 using DMPA should be reviewed regularly to ensure the benefits of continuing outweigh the risks, and those women who have additional risk factors for osteoporosis should be counselled on alternative methods of contraception. All women should be advised to stop DMPA by the age of 50, at which time they should switch to an alternative, safer method of contraception (FSRH, 2017a).

DMPA is not licensed for endometrial protection and cannot be used as the progestogen component of HRT.

Progestogen-only pill

The progestogen-only pills (POPs) are also not associated with an increased risk in cardiovascular disease or detrimental effect on bone mineral density. The desogestrel containing POP inhibits ovulation for most women and can therefore help alleviate pain associated with ovulation and menstruation (FSRH 2017a); however, almost half of women using POPs will experience an altered bleeding pattern, which may or may not be acceptable to them. POPs are not licensed for use as endometrial protection. There is no upper age limit and they can be safely used until a woman no longer requires contraception.

Barrier methods

Barrier methods such as condoms and diaphragms have higher failure rates than hormonal and intrauterine contraception, but pose no age-related health risks. Age-related anatomical and physiological changes, however, may make barrier methods unsuitable.

Women with vaginal prolapse may be unable to use a diaphragm; women experiencing vaginal dryness may find this is exacerbated by condoms, so should be advised about compatible lubricants, avoiding oil-based preparations that can cause condom breakages; and older men have an increased incidence of erectile dysfunction, the presence of which can be incompatible with male condom use.

Fertility awareness methods

Fertility awareness methods (FAM) rely on physiological signs and symptoms to predict ovulation. In perimenopause this becomes problematic due to irregular menstrual cycles and unpredictable ovulation, thus making it a less reliable method of contraception.

Emergency contraception

There is no upper age restriction for use of emergency oral contraception or specific age-related risks for women over 40. However, howeverthe estimation of earliest date of ovulation and therefore predictions on the efficacy and suitability of emergency contraception may be complicated by unpredictable cycles in perimenopause. As with younger women, the copper IUD is the most effective method of emergency contraception (FSRH, 2017b). It also provides immediate ongoing contraception and unlike oral emergency contraception, does not interact with other medication (FSRH, 2017b). Oral Ulipristal Acetate, a progesterone receptor modulator, is not suitable for women using progestogen-containing HRT as the progestogen may reduce the efficacy of the Ulipristal Acetate (FSRH, 2017a).

Conclusions

While natural fertility declines for women in their 40s, contraception should be used until menopause by those wishing to avoid unintended pregnancy. Contraceptive choice at this age may be influenced by many factors, including other health conditions, menstrual bleeding patterns and symptoms of perimenopause. For premenopausal women who wish to use HRT to manage menopausal symptoms, it is important to advise the use of additional contraception to prevent unintended pregnancy.

Key Points

• Although fertility naturally declines with age, effective contraception is required until menopause for women who do not wish to become pregnant
• Non-hormonal methods of contraception should be continued until 1 year after last menstrual period (LMP) if the woman is >50 years old, or 2 years after LMP if she is <50 years old
• Women do not require contraception beyond the age of 55
• By the age of 50, the risks of injectable contraception and combined hormonal contraception outweigh the benefits and women should be advised to stop and switch to a safer, alternative method of contraception
• There is no upper age limit for the progestogen-only pill, progestogen implant or intrauterine contraception and women can use these until contraception is no longer required
• Hormone replacement therapy cannot be relied upon for contraception

CPD reflective questions

• A 48-year-old woman with regular periods was recently started on HRT for management of troublesome vasomotor symptoms. She has an intact uterus and suffers from migraines, so was commenced on a cyclical transdermal preparation. She is sexually active with a new partner and would like to know if she needs to use contraception. How would you advise her and what methods would be most suitable for her?
• A 49-year-old woman had a 5-year copper coil fitted at age 44. She has booked an appointment to have her coil removed and replaced. She has not had a period for 12 months and is sexually active. What would you advise her about the duration of use for her IUD and her risk of pregnancy?
• A 42-year-old woman would like advice about contraception. She has no significant medical or family history, normal blood pressure and a BMI of 26. She has a long-standing history of heavy menstrual bleeding and mid-cycle pain associated with ovulation. Due to a change in personal circumstances, this is no longer acceptable to her and she would like advice on how to manage it. She currently uses condoms for contraception