The levonorgestrel intra-uterine system: therapeutic application in family planning

The levonorgestrel intra-uterine system: Therapeutic application
in family planning
Lucia Margaret Dolan, MB BCh, MRCGP, MRCOG, Specialist Registrar Obstetrics and Gynaecology; Margaret Mulholland,
MB BCh, BAO, MFFP, Family Planning Officer; John Price, MD, FRCOG, Consultant Obstetrician/Gynaecologist, Belfast City
Hospital, Belfast, Northern Ireland. Institution: Ulster Community and Hospital Trusts, Ulster Hospital, Dundonald, Belfast,Northern Ireland Correspondence: Dr Lucia Dolan, Specialist Registrar in Obstetrics and Gynaecology, The Warrell Unit, Saint Mary’s
the Initial Management of Menorrhagia. Yet, despite the Objective. To assess the non-contraceptive benefits of the apparent clinical benefits, Murty et al found that cost and levonorgestrel intra-uterine system 12 months following supply influenced clinical practice when introducing it into insertion in a family planning setting. a UK family planning service.3 This has also been the Design. Postal questionnaire survey. experience in the Northern Ireland region, where the supply Setting. Family planning clinics at the Ulster and Bangor to hospital family planning clinics has been limited and there has been reluctance by some general practitioners Subjects. Eighty-six consecutive subjects fitted with the (GPs) to supply the system given the high initial cost and levonorgestrel intra-uterine system. Results. Response rate 87.3%. Outcome measured in terms This survey was undertaken to establish whether the of compliance, satisfaction and menstrual symptomatology. non-contraceptive benefits of the LNG-IUS on menstrual Reasons for insertion were as follows: 21.7% contraception function could be achieved in local family planning clinics.
only; 65.2% menorrhagia, 24.6% dysmenorrhoea and 1.4% Patient outcome was measured in terms of compliance, premenstrual syndrome. Duration of menses was 8.25 days satisfaction and menstrual symptomatology after 1 year pre-insertion and 2.41 days at 12 months. Of the subjects, 59.4% experienced at least one hormonal side effect; 10.1%of systems were removed within 12 months. At 12 months 86.9% of women were satisfied and 9.8% of women planned All subjects were recruited from two hospital family planning clinics organised by the Ulster Community and Conclusion. The levonorgestrel intra-uterine system was Hospitals Trust. Subjects considered to be suitable for the acceptable to almost 80% of women after 12 months, with LNG-IUS had counselling and then returned for a secondvisit at the next period to have the system fitted. Supplies significant reduction in duration of menses. Family were obtained from family planning stocks or from the planning clinics are an ideal setting to implement the chemist if the GP had supplied a prescription.
guidelines for the initial management of menorrhagia. A standard technique was used and all women received mefenamic acid 500 mg on the night and morning prior to Key words
insertion. Instillagel was applied to both the endocervical benefits, compliance, family planning clinic, levonorgestrel canal and anterior cervical lip prior to insertion.
intra-uterine system, LNG-IUS, menstrual symptoma- A pilot questionnaire of explanation and SAE for return was posted to 12 subjects to assess the design of thequestionnaire. Postal questionnaires with a covering letter ofexplanation and SAE for return were sent to 86 consecutive Key message points
subjects in the main survey. Four weeks later non- This survey was conducted to establish whether the non- respondents were contacted by telephone and a second contraceptive benefits of the LNG-IUS on menstrual function could questionnaire with covering letter and SAE for return was be achieved in local family planning clinics. posted. The questionnaire comprised questions on age, Patient outcome was measured in terms of compliance, satisfaction parity, previous contraception, reason for insertion of LNG- and menstrual symptomatology 1 year following insertion of the IUS, iron supplementation, pain on insertion, menstrual The levonorgestrel intra-uterine system was acceptable to almost function, side effects, satisfaction, future pregnancies and 80% of women after 12 months, with significant reduction in future contraception. Non-respondents and respondents were compared with respect to age. Validation of the Family planning clinics are an ideal setting to implement theguidelines for the initial management of menorrhagia.
questionnaire was carried out by reviewing the clinicalcharts of 15 subjects and comparing the postal questionnaireresponses with those documented at the time of family Introduction
planning review at three and 12 months following insertion. The levonorgestrel intra-uterine system (MirenaR LNG- To ensure confidentiality, data were transferred to IUS) was first licensed for contraceptive use in the UK in computer using numerical coding and analysis was carried May 1995. It’s convenience, combined with annual out using the Statistical Package for the Social Services pregnancy rates of 0.16 per 100 women-years1 and rapid (SPSS). Statistical analysis was carried out using an reversibility of action2 makes it an ideal contraceptive.
independent sample ‘t’ test and Mann Whitney U tests for More recently the additional non-contraceptive benefits statistical significance, p < 0.05 denoting statistical have been highlighted by the RCOG in the Guidelines for The Journal of Family Planning and Reproductive Health Care 2001: 27(1): 19-21
Original Article
Table 3 Side effects
The pilot response rate was 66.7% (8/12) following one posting. Questionnaires were well completed with no Eighty-six subjects were included in the first posting of the main survey. Seven of these subjects were ineligible as questionnaires were returned marked ‘wrong address’ and these patients were lost to follow-up. The overall response rate following two postings in the main survey was 87.3% (69/79). The age range of the subjects was 25-51 years, and mean parity was 2.54 (range 0-5). One subject had a previous history of miscarriage. Respondents and non- respondents showed no significant difference in age using effect and that the side-effects were as follows: breast Fisher’s Exact Test X2 = 2.84, p = 0.06.
tenderness 57.9% (40/69); mood changes 39.1% (27/69); All the women (100%; 69/69) requested reliable backache 34.8% (24/69); acne 17.4% (12/69); others 18.8% contraception. Table 1 illustrates the reasons for insertion of (13/69); inter-menstrual spotting > 4 days at 12 months the LNG-IUS: 21.7% (15/69) contraception only, 65.2% 6.6% (4/61). On multivariate analysis mood changes were (45/69) menorrhagia, 24.6% (17/69) dysmenorrhoea, 1.4% the only side effect to be associated with non-satisfaction (Mann-Whitney U two tailed test U=369.5 W = 694.500 Table 4 illustrates patient satisfaction and shows that Table 1 Reason for LNG-IUS insertion
86.9% (53/61) of women were satisfied/very satisfied at 1 year. Within the first 12 months 10.1% (8/69) of systems were removed. Reasons for removal were: coil expulsion (n = 2); acne (n = 2); headaches (n = 1); heavy bleeding (n = 2); sterilisation (n = 1). Of the subjects, 9.84% (6/61) planned to discontinue after 1 year. Four of these women had inter-menstrual spotting > 4 days duration and one Table 4 Subject satisfaction with the LNG-IUS
With respect to family, 76.8% (53/69) declared their family complete; 10.1% (7/69) declared their family not complete and 13.0% (9/69) declared unsure.
Of the subjects, 44.9% (31/69) had an existing copper device; 34.8% (24/69) had not previously used an IUD.
Table 2 illustrates menstrual outcome using an independent sample ‘t’ test for statistical analysis. The pre- insertion mean duration of menses was 8.25 (95% CI 6.93-9.57 days), which was reduced to 4.00 days (95% CI 2.66-5.34) at 3 months (p = 0.000), and to 2.41 days (95% Discussion
CI 0-4.82) at 12 months (p = 0.000). The median duration This review of the therapeutic application of the LNG-IUS of inter-menstrual spotting was 0.95 days (95% CI to a UK family planning setting demonstrates that at 1 year 0.52-0.94) prior to insertion; 2.19 days (95% CI 1.03-3.35) 89.9% of women were compliant and 6.25% of women at 3 months (p = 0.049), and 1.84 (95% CI 0.7-2.98) at required removal of the system for either hormonal reasons 12 months (p = 0.223). At 12 months 24.6% (15/61) of or continued heavy bleeding within the first year. Removal rates for hormonal reasons have been reported as 2.3 per 100 LNG-IUS users compared with 0.1 for Nova-T users after 1 year.4 In this survey numbers were much smaller Table 2 Menstrual outcome
than in both of these studies and this may have accounted for the apparently higher removal rates. Whilst we observed that the majority of women experienced transient hormonal side effects and that these were usually multiple, acne and headaches were the only two side effects reported which led to removal of the LNG-IUS. This finding is consistent with that reported by Sivin and Stern1 who found significantly * Analysis: an independent samples ‘t’ test, using a one tailed test.
higher rates of removal in women who experienced either headaches or acne. Women may find these two side effects The pre-insertion mean number of pads/tampons was unacceptable even in the short-term, whilst careful pre- 28.35 (95% CI 18.71-37.99), which fell to 12.31 (95% CI insertion counselling is likely to have ensured that almost 5.89-18.73) at 3 months (p = 0.000) and to 5.02 (95% CI 90% of women were still compliant 1 year even when other 2.38-7.40) at 12 months (p = 0.000).
Prior to LNG-IUS insertion, 20.2% (14/69) of subjects In this survey 65.2% of women complained of heavy were taking oral supplements for heavy periods and 15.9% periods. Chimbira et al5 have previously noted that only (11/69) had taken time off work during their period.
40% of women complaining of menorrhagia have a Table 3 illustrates the side effects experienced. It can be > 80 mls blood loss per cycle when it is objectively seen that 59.4% (41/69) had at least one hormonal side measured. We did not objectively measure menstrual blood The Journal of Family Planning and Reproductive Health Care 2001: 27(1): 19-21
The levornorgestrel intra-uterine system: Therapeutic application in family planning Original Article
loss, but quantified loss by the number of sanitary pads and and it has been included as an RCOG Category A the duration of menstrual bleeding as these are clinical recommendation in the initial management of menorrhagia.
means that often determine whether treatment is initiated. At We have illustrated the acceptability of the LNG-IUS both both three and 12 months blood loss was significantly in terms of patient compliance and improvement in reduced in terms of both the number of bleeding days and menstrual symptoms when used in a family planning clinic the need for sanitary pads. However, 4.4% of women with in accordance with the recent RCOG guidelines.
heavy periods continued to bleed heavily and required the LNG-IUS to be removed within 1 year. Irvine et al6 have Conclusion
reported a reduction in bleeding at 3 months of 94%; Tang Family planning doctors are in an ideal situation to and Lo7 reported a 95% reduction at 6 months and implement the RCOG Guidelines for the initial Andersson and Rybo8 reported a 97% reduction at management of menorrhagia, given their experience in both 12 months. In each of these three studies the LNG-IUS was pelvic assessment and insertion of IUCDs. The overall used in cases of objectively proven menorrhagia. Improved acceptability of the LNG-IUS to the community surveyed quality of life was reported in our survey: women who had may encourage GPs to provide funding and thus improve previously required iron supplementation or who had taken supply, and some may also consider directly referring time off work were no longer doing so at 12 months. Women patients with menorrhagia to the family planning clinic for with inter-menstrual bleeding did not request removal of the fitting of a LNG-IUS when clinically indicated.
LNG-IUS within the first 12 months. However, at 12 months all four women who still experienced inter-menstrual Acknowledgements
bleeding of more than 4 days duration in each cycle planned The authors wish to thank the Audit Department in the Ulster Hospital,Dundonald for their help in compilation of the data and Mr Mike Stevenson for his statistical advice.
Amenorrhoea at 1 year was reported by almost 25% of women, but only one of these women planned to Statements on funding and competing interests
discontinue use. Termination rates due to amenorrhoea are Competing interests. None declared. very variable. Andersson et al2 reported a termination rate of 1.5 per 100 years because of amenorrhoea at the end of 1 Sivin I, Stern J. Health during prolonged use of levonorgestrel 20 µg/d and Copper Tcu 380Ag the first year when comparing the Nova-T IUD and the intrauterine contraceptive devices: a multicentre study. LNG-IUS; 11.6 per 100 was reported by Luukkainen et al9 2 Andersson K, Batar I, Rybo G. Return to fertility after removal of a levonorgestrel releasing at 5 years and 4.4 per 100 years by Sivin and Stern.1 Low 3 Murty J, Barron A, Searle E. Auditing the introduction of a new product to a family planning discontinuation due to amenorrhoea in our survey may have 4 Andersson K, Odlind V, Rybo G. Levonorgestrel-releasing and copper releasing (Nova T) IUDs reflected the lifestyle improvement for those women who during five years of use: A randomised comparative trial. 5 Chimbira TH, Anderson AB, Turnbull AC. Relation between measured menstrual blood loss and had previously complained of heavy periods, and patient’s subjective assessment of loss, duration of bleeding, number of sanitary towels used, uterine weight and endometrial surface area. counselling prior to insertion may have provided the 6 Irvine GA, Campbell-Brown MB, Lumsden MA, et al. Randomised comparative trial of levonorgestrel intrauterine system and norethisterone for treatment of idiopathic menorrhagia.
reassurance that amenorrhoea did not signify pregnancy.
7 Tang GW, Lo SS. Levonorgestrel intrauterine device in the treatment of menorrhagia in Chinese This survey demonstrated that 86.9% of women were 8 Andersson JK, Rybo G. Levonorgestrel-releasing intrauterine device in the treatment of either satisfied or very satisfied after 1 year. Whilst the menorrhagia. Br J Obstet Gynaecol 1990: 97; 690–699.
LNG-IUS is as yet unlicensed for menorrhagia in the UK, it 9 Luukkainen MD, Allonen H, Haukamaa M, et al. Five years experience with Levonorgestrel- may be prescribed on a named-patient basis for this purpose The Journal of Family Planning and Reproductive Health Care 2001: 27(1): 19-21
The levonorgestrel intra-uterine system:
Therapeutic application in family
planning
Lucia Margaret Dolan, Margaret Mulholland and John Price J Fam Plann Reprod Health Caredoi: 10.1783/147118901101195056 Updated information and services can be found at: Email alerting
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