VAGINAL CONTRACEPTIVE RING – ADVANTAGES AND DISADVANTAGES?

D.S. Seidman
Research Unit, Department of Obstetrics and Gynecology, Chaim Sheba Medical Center, Tel-Hashomer and Sackler
Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel

The use of effective medical contraception, such as the pill and the intrauterine device, is now
increasingly common in all developed nations. However, at the same time, the incidence of
induced abortions has remained rather stable in many of those countries. Since only a
minority of couples experiencing an unplanned pregnancy did not use an effective
contraception, it seems that contraceptive failure is frequently a consequence of misuse of
contraceptive methods, including hormonal ones. It seems clear that there is a place for
effective contraception that is friendlier in regard to day-to-day management and less
influenced by gastrointestinal problems and concurrent medication intake. It is not surprising
that studies of women's attitudes show that many regard the compliance required with daily
pill use as a drawback to the use of the oral contraception and would prefer a monthly
contraceptive option. This has been one of the major motivating forces behind the continuing
search for new contraceptives options. One of the more novel and promising approaches is
vaginal delivery of hormonal contraception.
The rationale for using vaginally administered contraception stems from the ease of insertion
by women, and the fact that it is used on a monthly base, omitting the need for daily ingestion.
Furthermore, the continuous delivery, through the use of controlled release formulations,
ensures constant serum hormone levels, allowing the use of the lowest doses of ethinyl
estradiol, yet allowing for good cycle control. Vaginal administration precludes
gastrointestinal interference with absorption and avoids hepatic first-pass metabolism of the
progestin.
A novel combined hormonal vaginal contraceptive ring (VCR) is currently commercially
marketed (NuvaRing®, NV Organon, Oss, The Netherlands). This VCR continuously
releases 15 µg of ethinyl estradiol and 120 µg of etonogestrel, the active metabolite of the
progestin desogestrel. The VCR is soft and flexible, with an outer diameter of 54 mm and a
cross section of 4 mm.
The contraceptive cycle of the VCR is commenced when pregnancy can be excluded, usually
within 5 days of menses. The VCR is flexible and simple to insert and remove. The VCR is
easily inserted at a woman’s discretion. It is inserted and removed by pressing the sides of
the ring together between the thumb and index finger and
gently pushing it in or pulling it out of the vagina. Like a tampon, the ring can be placed
anywhere in the vagina that is comfortable. There is no specific fit or need to check the
position of the ring. There is no wrong way to insert the VCR; if it lies comfortably in the
vagina, it has been placed correctly. When the VCR causes pressure, the user may just push
it further into the vagina. The VCR is worn for 3 weeks and discarded. A new ring is inserted
1 week later, offering a 28 day cycle similar to that of the oral contraceptive pill.
Due to the controlled release mechanism of the contraceptive ring, steroid concentrations
remain uniform throughout the cycle. If a woman forgets to remove the VCR after 3 weeks, it
will continue to inhibit ovulation for an additional two weeks. Ovulation returns quickly after a
woman stops using the ring. If the VCR is out for more than 3 hours during the first 3 weeks
of the cycle, effective contraception cannot be guaranteed.
Large mulicenter studies of the VCR have revealed a high contraceptive efficacy, with a Pearl
Index of 0.65 and 1.18. Cycle control is excellent with irregular bleeding reported in about 5%
or less of all cycles with the VCR.
A recent multicenter, open-label, trial randomized in a 13-cycle study 983 women to be
treated with the VCR or a combined oral contraceptive (COC), containing 30 microg of ethinyl
estradiol (EE) and 3 mg of drospirenone (Contraception 2006;74:451-7). One in-treatment
pregnancy occurred with VCR (Pearl Index=0.25) and four with the COC (Pearl Index=0.99).
For both groups, compliance (89.2% VCR, 85.5% COC) and satisfaction (84% VCR; 87%
COC) were high. The vast majority of women found VCR easy to insert (96%) and remove
(97%). Tolerability was similar; the most frequent adverse events with VCR were related to
ring use, whereas estrogen-related events were more common with the COC. The authors
concluded that the VCR has comparable efficacy and tolerability to a COC containing 30
microg of EE and 3 mg drospirenone. User acceptability of both methods was high.
The Swedish authors also compared, in the women enrolled in the above study, the cycle
control, cycle-related characteristics and bodyweight effects of the VCR with those of the
COC (Hum Reprod. 2006;21:2304-11). They found that breakthrough bleeding or spotting
during cycles 2-13 was in general less frequent with VCR than that with the COC (4.7-10.4%)
and showed a statistically significant odds ratio of 0.61 (95% confidence interval: 0.46, 0.80)
with longitudinal analysis. Intended bleeding was significantly better for all cycles with VCR
(55.2-68.5%) than that with the COC (35.6-56.6%) (P < 0.01). Changes from baseline in
mean bodyweight and body composition parameters were relatively small for both groups with
no notable between-group differences. Thus, the authors concluded that the VCR was
associated with better cycle control than the COC, and there was no clinically relevant
difference between the two groups in bodyweight.
The most frequently reported adverse events associated with the use of the VCR are device-
related events (e.g. foreign body sensation, coital problems and device expulsion), vaginal
discomfort, headache, vaginitis and leucorrhea.
The overall acceptance of the VCR was high, as 96% of patients were satisfied with the ring
and 97% would recommend the ring. The VCR represents an important new option for
women desiring a highly effective contraction. Its ease of use and exceptional cycle control
seem to result in high patient compliance.

Table 1. The advantages of the vaginal contraceptive ring.

High efficacy comparable to oral contraceptives.
Controlled release formulation allows continuous delivery, ensuring constant serum hormone levels, permitting the
use of the lowest doses of ethinyl estradiol, thereby reducing the occurrence of dose-related adverse events.
Possibility of administering both estrogens and progestogens.
Low and steady hormone levels result in little spotting or irregular bleeding.
High patient compliance as dosage schedule is easy to follow. The ring only needs to be changed once a month.
Easily inserted and removed by the user herself.
If a woman forgets to remove the ring after 3 weeks, it will continue to inhibit ovulation for an additional two weeks.
Vaginal administration precludes gastrointestinal interference with absorption.
No hepatic first-pass metabolism of the progestin
Ovulation returns quickly after a woman stops using the ring.

Table 2. The disadvantages of the vaginal contraceptive ring.

Does not provide protection against STDs.
Not recommended for women with cystocele, rectocele or uterine prolapse.
Reported side effects include vaginal infections and irritation, discharge, headache, weight gain, and nausea, some
of which are similar to those of birth control pills.
Premature discontinuation due to vaginal discomfort and device related events, including foreign body sensation,
coital problems and device expulsion.
If the VCR is out for more than 3 hours during the first 3 weeks of the cycle, effective contraception cannot be
guaranteed. The ring must be rinsed with warm water and reinserted within 3 hours to maintain efficacy.
Women who use the ring are strongly advised not to smoke, as doing so can increase the risk of severe
cardiovascular side effects.
Not suggested for women who are or may be pregnant, or have blood clots, severe high blood pressure, certain
cancers or a history of heart attacks and strokes.