NuvaRing improves cycle control in German women
S. Baumgaertner (1), E. Merkle (2)
Organon GmbH, Oberschleiheim, Germany (1); Private Practice, Bad
Reichenhall, Germany (2)
Introduction: Combined oral contraceptives (COCs) are often used for
many years, and many women may welcome a form of contraception that does not
require daily administration. NuvaRing is a once-a-month contraceptive vaginal
ring that releases 15 µg ethinylestradiol (EE) per day and has superior cycle
control compared with a COC containing 30 µg EE (data presented at this
meeting). This study was conducted to collect information on cycle control,
acceptability and tolerability in a large number of NuvaRing users in Germany.
Design and methods: This open, prospective, multi-centre study was
conducted by gynaecologists in general practices in Germany. Women expressing a
wish for contraception entered the study and used NuvaRing for 6 consecutive
cycles, each comprising 3 weeks of ring use followed by a 1-week ring-free
period. Information on cycle control, bleeding patterns and dysmenorrhoea was
recorded at baseline and after cycles 3 and 6.
Results: A total of 5823 subjects underwent all three examinations.
The mean age of the subjects was 29.4 years (SD 7.3). At baseline, 16.6% of
subjects had an irregular bleeding pattern, but by the final examination, this
decreased to 2.8%. Overall, duration of bleeding decreased from baseline to the
final visit as shown in the table, which shows the percentages of women with
different bleeding times.
| 2–3 days | 4–5 days | 4–6 days | 6–8 days | 10–12 days | |
| Baseline (%) | 16.9 | 58.5 | 17.6 | 2.1 | 1.0 |
| Final (%) | 28.4 | 52.7 | 6.3 | 0.3 | 0.2 |
At baseline, 25.1% of subjects experienced mild bleeding and this increased
to 43.4% at the final visit. The proportion of subjects who experienced moderate
or severe bleeding at baseline decreased from 60.7% and 13.1%, respectively, to
44.5% and 2.4%, respectively, at the final visit. Breakthrough bleeding,
reported by 16.8% of subjects at baseline, decreased to 4.9% at the final visit.
The proportion of subjects who experienced dysmenorrhoea also decreased, from
25.9% at baseline to 5.7% by the final visit. The majority of subjects (81.8%)
were either satisfied or very satisfied with NuvaRing, and most (72.1%) intended
to continue using it after the study ended. Adverse events were recorded in 9.9%
of subjects. There were 19 serious adverse events, 5 of which were treatment
related.
Conclusions: These results show that in addition to being an effective,
convenient and acceptable form of contraception, NuvaRing improves all aspects
of cycle control, including severity of bleeding, breakthrough bleeding and
dysmenorrhoea.
