A study was performed to establish the tolerance, acceptability and associa
ted efficacy of a levonorgestrel-releasing intravaginal ring (IVR) in a sam
ple of British women requiring contraception. This was achieved with an ope
n non-randomized prospective study of 1710 women aged 18-40 years, recruite
d in 75 centers geographically spread around the UK using an IVR designed t
o release 20 mug/day of levonorgestrel. Assessments were made at baseline,
after 6 weeks, after 3 months and then 3-monthly. After initial insertion o
f the IVR, it was changed at 3-monthly intervals. A total of 1591 women wer
e eligible for analysis, with 572 available after 12 months and 34 after 24
months of use. Life-table analysis revealed pregnancy rates of 5.1% and 6.
5% at 12 months and 24 months, respectively. The IVR was rated as acceptabl
e or very acceptable as a form of contraceptive by 60.7% of women at 12 mon
ths. The most common adverse events were menstrual disturbance, headache an
d vaginal discharge. No significant pattern of biochemical, hematological,
microbiological or cytological abnormalities was found but vaginal erythema
tous lesions were noted at some centers. This IVR was found to be a general
ly well-accepted method of contraception with a failure rate comparable to
some other progestogen-only methods. On this basis, further development of
hormone-releasing intravaginal rings is justified.