Combined Hormonal Contraception

New guidance from the Faculty of Sexual and Reproductive Healthcare reverses previous advice that women using combined hormonal contraception (CHC) should have a 7-day hormone-free break each cycle to allow for a monthly bleed and allows for a 12-month supply at first prescription

The FSRH update to its Guideline on Combined Hormonal Contraception states that the traditional 21/7 CHC regimen with a monthly withdrawal bleed confers no health benefit over other patterns of CHC use. In addition, symptoms associated with hormone-free interval can cause problems: withdrawal bleeding may be heavy, painful or simply unwanted, and may be associated with headache and mood changes. There is a risk of ovulation during the 7-day break, especially with lower doses of ethinylestradiol (EE) and if use is not perfect.

The guideline highlights the fact that tailored regimens in which there are fewer or no hormone-free intervals (HFI) or shortened breaks can be safely used to avoid withdrawal bleeds and associated symptoms, and could reduce the risk of contraceptive failure.

Standard regimens

Most combined oral contraception (COC) in the UK is designed to be taken as 28-day cycles, with 21 consecutive daily active pills followed by a 7-day break before starting the next pack of pills. The first seven pills inhibit ovulation, and the remaining 14 maintain anovulation. The 7-day break is achieved either by having 7 pill-free days or taking seven placebo tablets. Most women will have a withdrawal bleed due to endometrial shedding, but this is not the same as menstruation and has no health benefit.

For women using the combined hormonal transdermal patch, the regimen follows the same pattern. The patch is applied and worn for 7 days, then replaced weekly for two further weeks. The fourth week is patch-free to allow a withdrawal bleed, before a new patch is applied.

The combined vaginal ring is inserted into the vagina and left in place for 21 days, followed by a 7-day break to allow a withdrawal bleed, before a new ring is inserted.

Tailored regimens

Tailored CHC regimens include:

• Continuous use of CHC (no HFI)
• Extended use of CHC (less frequent HFI); timing of HFI can be fixed or flexible
• Shortened HFI (e.g. 4 days) after each 21 days of CHC use

The FSRH supports off-label use of tailored CHC regimens – see Table 1.

Medical eligibility

Contraindications to the use of CHC have not been changed. Refer to the UK Medical Eligibility Criteria (UKMEC) 2016 https://www.fsrh.org/ukmec/ . Women over the age of 50 should generally use safer alternative contraception. Consider concomitant use of other drugs: hepatic enzyme-inducing drugs could reduce the contraceptive effectiveness of all CHC methods, and contraceptive hormones can affect serum levels of drugs such as lamotrigine with potentially significant clinical effects. Women using drugs that may affect fetal development should be encouraged to use the most effective long acting reversible contraception (LARC) methods.

A woman requesting CHC who is medically eligible should be given information about effectiveness of CHC and alternatives including LARC. If CHC is preferred, a COC containing ≤30 μg EE in combination with levonorgestrel (LNG) or norethisterone (NET) is a reasonable first-line option to minimise venous thromboembolism risk. Women may choose other preparations or routes of administration depending on their past experience of side effects and personal preference. Non-oral CHC may be considered if there are concerns about absorption of COC.

Starting CHC

CHC containing EE can be started by medically eligible women up to and including day 5 of a natural menstrual cycle without the need for additional contraceptive protection (such as condoms or abstinence).

CHC containing EE can be quick started at other times (with advice to use additional contraceptive protection for 7 days) if it is reasonably certain that the woman is not pregnant, or a high sensitivity urine pregnancy test is negative, even if there is a risk of pregnancy from unprotected sexual intercourse (UPSI) in the last 21 days. A follow up high sensitivity urine pregnancy test is required 21 days after the last UPSI. Almost all the available evidence suggests no adverse impact of exposure to contraceptive hormones on pregnancy outcomes or risk of fetal abnormality.

NB. Quick starting CHC should be delayed for 5 days after ulipristal acetate oral emergency contraception.

Provision of CHC

Up to a year’s supply of CHC may be prescribed at the first consultation (although only 3 months of the combined vaginal ring may be dispensed at any one time).

The FSRH guideline development group recommends that a 1-year supply may help to avoid the risk of unwanted discontinuation of the method and reduce the risk of pregnancy. Although there could be some wastage, costs and resource use associated with frequent follow-up appointments are avoided. However, a 3-month supply may be more appropriate for women with pre-existing medical conditions who may benefit from more regular follow-up.

A 12-month supply for women who are established on the patch is considered reasonable. The combined hormonal vaginal ring has to be kept refrigerated after manufacturer and can only be stored at room temperature once it is dispensed for a maximum of 4 months, so no more than one pack of three rings should be provided at any one time.

Missed pills and other incorrect use of CHC

Missing CHC increases the risk of ovulation and conception. Women who miss pills or make mistakes with their patch or vaginal ring are at increased risk of pregnancy compared with women who use CHC perfectly. Women who frequently miss COCs or make repeated mistakes with a patch or vaginal ring should be advised to consider an alternative method that is less dependent on the user to be effective. Guidance on incorrect use of CHC is currently being reviewed, but the interim advice is available at https://www.fsrh.org/standards-and-guidance/current-clinical-guidance/method-specific/. The FSRH states: ‘Repeated attempts to re-write “missed pill rules” which more accurately reflect the evidence have concluded that simple rules are more likely to be followed. As a result advice… is overcautious. Nevertheless, a simple overcautious rule to which everyone agrees is better than complicated rules that are not followed.’

Routine review

Routine annual review is recommended for all women during CHC use. Follow-up should include annual recording of blood pressure and BMI but may be achieved without a face-to-face consultation. Medical eligibility, drug history, method adherence and satisfaction should also be reassessed.

Specific advice

• Women using CHC should be advised about reducing periods of immobility during travel
• Women trekking to high altitudes (above 4500m or 14,500 feet) for more than 1 week should be advised to consider switching to a safer alternative contraceptive method
• Women who are undergoing planned major surgery or expected period of limited mobility should be advised to stop CHC and to switch to an alternative contraceptive method 4 weeks beforehand

FSRH. Combined Hormonal Contraception, January 2019

https://www.fsrh.org/standards-and-guidance/current-clinical-guidance/method-specific/