Questions women may ask about NuvaRing

NuvaRing is a new once-a-month, flexible contraceptive ring, that is inserted into the vagina. It works like a combined oral contraceptive (COC), but contains a lower dose of estrogen in combination with the progestogen.

The ring contains 2.7 mg ethinylestradiol (EE) and 11.7 mg etonogestrel (releasing 15 μg EE and 120 μg etonogestrel daily).

The ring is made from ethinyl vinyl acetate, or EVA; a non-silicone plastic.

Each NuvaRing is individually packaged in a reclosable aluminium laminate sachet. NuvaRing is available in a box of one sachet or three sachets.

Vaginal rings offer a real alternative to COCs, with their contraceptive hormones being released vaginally, so avoiding first pass metabolism. The longer lasting action of vaginal rings also means that women do not need to remember to take their daily pill every day – NuvaRing offers a new option of monthly contraceptive convenience.

NuvaRing is available in more than 40 countries worldwide and it is estimated that there is more than 5.5 million women years exposure to NuvaRing.¹⁴

The efficacy of a contraceptive is measured by the Pearl Index. It measures the number of pregnancies likely to occur per 100 women-years of use, i.e. how many women would get pregnant if 100 used a given method of contraception for 1 year.

When used correctly, NuvaRing has a Pearl Index of 0.96 (0.64–1.39),¹ which equates to over 99% efficacy. This makes NuvaRing as reliable in preventing pregnancy as the combined oral contraceptive pill.

Most women find that NuvaRing is easy to use.

Once inserted, NuvaRing is left in place for 3 weeks. After this time, the woman removes the ring and waits 1 week – during which time she will experience a withdrawal bleed.

The shape and flexibility of NuvaRing make it simple for women to insert and remove it themselves.

Unlike a diaphragm, NuvaRing does not need to be placed round the neck of the cervix – it isn’t important where NuvaRing sits within the vagina as it is held in place by the vaginal wall.

After hands have been washed, NuvaRing is taken out of the sachet and squeezed between the fingers.

The woman finds a comfortable position to slide the ring into the vagina – just like inserting a tampon. Standing with one foot elevated on a stool or the toilet, squatting or lying down will make this easier.

The ring is gently pushed into the vagina until it is in a comfortable position – precise positioning is not required, as it will not affect the reliability of the ring.

NuvaRing can be removed by inserting the index finger into the vagina, locating the ring and gently pulling it out.

As well as being a highly effective contraceptive choice, NuvaRing offers the convenience of a once-a-month administration. A study has suggested that up to 47% of women who use a combined oral contraceptive (COC), miss one or more pills per cycle.⁹ With NuvaRing, there is no need to remember to take a daily pill.

NuvaRing offers a low and steady delivery of hormones that is more consistent than the contraceptive patch or a COC (30 μg ethinylestradiol and 150 μg levonorgestrel).¹⁰

Good cycle control is a key factor influencing contraceptive acceptability and compliance and NuvaRing has good cycle control^5,6,15 with a low incidence of irregular bleeding, even during the first cycle of use.⁵

As NuvaRing avoids gastrointestinal metabolism,¹¹ contraceptive efficacy is not compromised by vomiting or diarrhoea, which may be an efficacy issue with a COC.

NuvaRing is generally well tolerated and has manageable and predictable side effects.¹

User acceptability in trials was high,¹⁵ with the majority of women finding the NuvaRing easy to use and preferring it to the COC they had used previously.¹² Reasons for satisfaction with the NuvaRing included once-a-month administration, low hormonal dose and ease of use.¹²

NuvaRing offers an important addition to the range of contraceptives available because it allows women to choose from a wider range of options.

NuvaRing is particularly suitable for women who want a non-daily contraceptive without compromising cycle control, women with a busy irregular lifestyle and women who want to stay in control of their fertility. It is appropriate for the needs and lifestyles for some of these women as it may improve their compliance.¹⁶

NuvaRing should not be used in women who currently have the following conditions:

• Presence/history of venous thrombosis, with/without the involvement of pulmonary embolism.
• Presence/history of arterial thrombosis or prodromi of a thrombosis.
• Known predisposition for venous/arterial thrombosis, with/without hereditary involvement or the presence of severe/multiple risk factors.
• History of migraine with focal neurological symptoms. Diabetes mellitus with vascular involvement.
• Pancreatitis (or history thereof) if associated with severe hypertriglyceridemia.
• Presence/history of severe hepatic disease if liver function values are abnormal.
• Presence/history of liver tumours.
• Known/suspected sex-hormone dependent tumours. Undiagnosed vaginal bleeding.
• Hypersensitivity to any ingredients of NuvaRing.¹

For full details of NuvaRing contraindications see the Summary of Product Characteristics (SmPC).

NuvaRing is easy to switch to from other contraceptives.

NuvaRing releases low amounts of both ethinylestradiol and etonogestrel, and is thus considered a low dose combined hormonal contraceptive. It releases 15 μg ethinylestradiol daily and achieves steady levels of hormones in the blood – and exposes the women to only half the level of estrogen in the system of a woman using a combined oral contraceptive containing 30 μg ethinylestradiol.¹⁰

Etonogestrel levels peak during the first week of use and then gradually decline over 3 weeks.¹¹ 

NuvaRing is generally well tolerated.¹

The novel formulation of NuvaRing allows delivery of hormones at low dosages through the vaginal wall. This vaginal delivery avoids high peak concentrations and daily fluctuations, as well as avoiding the gastrointestinal tract and so bypassing the hepatic first‑pass metabolism.

User acceptability and satisfaction with NuvaRing have been investigated in large efficacy trials across Europe and North America.^8,15 The studies looked at tolerability – especially any adverse events resulting from the method itself, in addition to hormone-related effects. No unexpected adverse events were seen.

The most common undesirable effects seen in clinical trials were headache, vaginal infections and vaginal discharge, each reported by 5-6% of women.¹

As with other hormonal contraceptives, there are warnings for use and interactions with other medicinal products that may lead to breakthrough bleeding and/or contraceptive failure.¹ See SmPC for further details and for the effects that are common with other contraceptives.

Most women using NuvaRing experience good cycle control, with a regular withdrawal bleed during the ring-free week. Furthermore, irregular bleeding (i.e. spotting or breakthrough bleeding) is uncommon, even during the first cycle of use.⁵

Irregular bleeding, or heavy, prolonged bleeding is one of the main reasons that women cite as stopping the combined oral contraceptive (COC), or indeed for switching to another brand of COC.¹⁷ The majority of women using NuvaRing experienced scheduled withdrawal bleeding.⁵

Studies have shown a high level of acceptability for NuvaRing – in one clinical trial where 1492 women completed treatment (from an intent-to-treat group of 2393 women) – 96% were ‘satisfied’ or ‘very satisfied’ with NuvaRing and 97% said they would recommend NuvaRing to others.¹²

This high level of acceptability is supported by data from the same study where at baseline, 66% of the women considered the pill to be their preferred contraceptive method. After only three cycles using NuvaRing, 81% of those who completed the 3-month evaluation (n= 1950), said NuvaRing was their preferred method of contraception.¹²

The design of NuvaRing ensures that it will fit itself to the woman’s internal contours and stay in place comfortably and securely. Once inserted, the ring relaxes slightly and expands to fit the upper, wider part of the vagina. The narrower lower part of the vagina and the muscular sphincters then hold it comfortably in place, preventing it from falling out.

While it is extremely unlikely for the ring to be ejected, an analysis of the incidence of ring expulsion in 3,333 women and 33,462 cycles of use has been conducted. Expulsion was uncommon (0.5% of cycles) and typically occurred before women had got used to using NuvaRing.¹⁸

Once inserted in the vagina, NuvaRing is not noticeable by most women. Although some men may feel the ring in the vagina during intercourse, 90% of couples surveyed found this was acceptable.¹²

Yes, a woman can use tampons while she is using NuvaRing. Using tampons does not affect the contraceptive efficacy or tolerability of NuvaRing. On rare occasions, NuvaRing might be expelled while removing a tampon. If this happens, the woman should follow the advice in the patient information leaflet, which is to wash the device in lukewarm water (not hot water) and insert again immediately.

NuvaRing should not be used during pregnancy. If pregnancy occurs with NuvaRing in place, the ring should be removed. Extensive epidemiological studies have revealed neither an increased risk of birth defects in children born to women who used combined oral contraceptives (COCs) prior to pregnancy, nor such an effect when COCs were used inadvertently during early pregnancy.

However no clinical experience of the outcomes of pregnancies exposed to NuvaRing has been reported.

There is a rapid return to normal cycling and ovulation after stopping NuvaRing use. Results of a clinical study indicate that normal ovulation typically returns within one cycle.¹³

From manufacture, NuvaRing should be stored in a refrigerator at 2-8°C for no longer than 36 months. After being taken out of the refrigerator, NuvaRing can be stored for up to four months at up to 30°C.

NuvaRing should be left in the vagina for a continuous period of 3 weeks. If the ring is accidentally expelled and is left outside of the vagina for less than 3 hours contraceptive efficacy is not reduced. The woman should reinsert the ring as soon as possible, but at the latest within 3 hours.

If the ring has been out of the vagina for more than 3 hours during the 1st and 2nd week of use, contraceptive effectiveness may be reduced. The ring should be put back in as soon as possible and the woman should use an extra method of contraception, such as condoms, until the ring has been in for 7 days in a row.

If the ring has been out for more than 3 hours during the 3rd week, a woman can either:

1. insert a new ring immediately. Inserting a new ring will start the next 3-weeks of use. The woman may not experience a withdrawal bleed from her previous cycle. However, break-through spotting or bleeding may occur.
2. have her withdrawal bleed and insert a new ring no later than 7 days from the last day the previous ring was removed or expelled. This option should only be used if she had been using the ring continuously for the previous 7 days.

If a woman has an extended ‘ring-free’ period – i.e. forgets to reinsert the next NuvaRing after her week without NuvaRing in place – she should insert a new ring as soon as she remembers. A barrier method of contraception should be used in addition to NuvaRing for the next 7 days. If intercourse took place during the extended ring-free interval, the woman will have to consider that she may be pregnant: the longer the ring‑free interval (beyond the prescribed 7 days), the greater the risk of pregnancy.

As long as NuvaRing has been used for maximally 4 weeks, contraceptive efficacy is still adequate. The woman may maintain her one-week ring‑free interval and subsequently insert a new ring. If NuvaRing has been left in place for more than 4 weeks, contraceptive efficacy may be reduced and pregnancy should be ruled out before inserting a new NuvaRing.

In exceptional circumstances, if withdrawal bleeding needs to be delayed, a new ring may be inserted without having a ring-free interval. The next ring can be used for up to 3 weeks again. However, the woman may experience bleeding or spotting. Regular use of NuvaRing is then resumed after the usual one week ring-free interval.

To shift the withdrawal bleed to another day of the week, a woman can shorten the forthcoming ring‑free interval by as many days as she likes. The shorter the ring-free interval, the higher the risk that she will not have a withdrawal bleed and that she will experience breakthrough bleeding and spotting during the use of the next ring.

Using NuvaRing is associated with weight gain in some users.¹ In the large efficacy trials, over the 1-year treatment period, the weight of all subjects rose by 0.84 kg¹⁵; however this is comparable to all women over a year (using non-hormonal contraception or no contraception at all).

Two studies comparing NuvaRing with two widely used COCs; 30 μg ethinylestradiol (EE) and 3 mg drospirenone,³ and 30 μg EE and 150 μg levonorgestrel⁴ – show no significant differences in weight change between the two contraceptive groups.⁴

Women with hypertriglyceridemia or a family history of the condition, may be at an increased risk of pancreatitis when using hormonal contraceptives.

The effect of NuvaRing on lipid metabolism was compared with that of a combined oral contraceptive (COC) pill containing 30 μg ethinylestradiol and 150 μg levonorgestrel , using 83 healthy women.¹⁹

Neither NuvaRing nor the COC had any effect on total cholesterol; nor did NuvaRing alter levels of high-density lipoprotein (HDL) cholesterol. However, the COC was associated with a significant fall in HDL cholesterol, compared to NuvaRing, as well as a rise in low-density lipoprotein levels. Both NuvaRing and the COC lowered lipoprotein, a substance possibly linked to cardiovascular disease. Overall, these results suggest a minimal effect of NuvaRing on lipids.

Although small increases in blood pressure have been reported in many women using hormonal contraceptives, clinically relevant increases are rare. A definitive relationship between hormonal contraceptive use and clinical hypertension has not been established. It is not known how NuvaRing influences the risk of increased blood pressure compared with other combined oral contraceptives. However, blood pressure measurements in the large-scale efficacy studies described showed no relevant change from baseline in either diastolic or systolic values.¹⁵

Because NuvaRing is administered vaginally, local effects on the vaginal and cervical epithelium (surface tissue) have been studied.²⁰ Cervical microbiology was carried out regularly, as were colposcopic examinations. NuvaRing was in place for a one year. Cervical cytology was rated using the Papanicolou (PAP) classification (a standard measure of cellular change).

This study confirmed that NuvaRing has no unfavourable effects on cervical cytology.²⁰ This result is in line with findings from the large scale study ¹⁵ in which fewer then 2% of subjects (1.7% of 2332 women) showed any change in PAP class rating over the year’s study period.

A study in 103 women compared the effects of NuvaRing on bone mineral density in healthy pre-menopausal women with a group using a non-hormonal contraceptive.²¹ After 2 years of continuous use (i.e. over 26 cycles), NuvaRing produced no changes in bone mineral density.

Antibiotics

Interactions between hormonal contraceptives and other medicinal products may lead to breakthrough bleeding and/or contraceptive failure.

In a pharmacokinetic interaction study,²² oral administration of amoxicillin (875 mg, two times daily) or doxycycline (200 mg on day 1, followed by 100 mg per day) for 10 days during use of NuvaRing, did not significantly affect pharmacokinetics of ethinylestradiol and etonogestrel.

Women on treatment with antibiotics (except amoxicillin and doxycycline) should use an additional barrier method of contraception until 7 days after the discontinuation. If concomitant drug administration runs beyond 3 weeks of a ring cycle, the next ring should be inserted immediately, without having the usual ring-free interval.¹

Other drugs

Certain drugs that affect the way the liver breaks down the hormones released by NuvaRing can theoretically reduce the effectiveness of hormonal contraceptives. Although the vaginal route of administration of NuvaRing means the livers effects on the hormones are reduced in comparison with oral drugs, women may be advised to use an additional barrier method of contraception with NuvaRing if taking drugs that can increase the clearance rate of sex hormones through the induction of cytochrome P450 isozymes.

Drugs inducing these liver enzymes include: phenytoin, phenobarbital, primidone, carbamazepine, rifampicin, oxzarbazepine, topiramate, felbamate, ritonavir, griseofulvin, and products containing St John’s Wort.

Women on treatment with any of these medicinal products should temporarily use a barrier method in addition to NuvaRing or choose another method of contraception. With hepatic microsomal enzyme-inducing drugs, the barrier method should be used during the time of concomitant drug administration and for 28 days after their discontinuation.

MSD offers a complete range of patient support materials to help patients who may be considering using NuvaRing.

These include:

• A counselling card for healthcare professionals  to use with women who have just been prescribed NuvaRing
• A comprehensive Q&A booklet for women, outlining how to insert and remove the ring and answering commonly asked questions about NuvaRing
• Free SMS alerts and diary stickers to remind patients to insert or remove NuvaRing and when their repeat prescription is due