Search

STUDY QUESTION: Is small uterine cavity size as assessed by ultrasonography associated with bleeding problems or pain in nulligravid women using intrauterine contraception, or do other factors affect these parameters? SUMMARY ANSWER: Among levonorgestrel intrauterine system (LNG-IUS) users, small uterine cavity size is not associated with worsened clinical outcome, but is beneficial as women with the smallest cavity measurements were frequently amenorrhoeic and painless at the end of the first year but among copper intrauterine device (IUD) users, no associations between uterine cavity dimensions and clinical outcome were found. WHAT IS KNOWN ALREADY: Nulligravid and nulliparous women have smaller uterine dimensions than parous women. Previously, many studies have revealed increased discontinuation rates of IUD use as a result of bleeding, pain or expulsion in these women, while recent studies with current models of IUS/IUDs indicate similar continuation and satisfaction rates irrespective of parity. STUDY DESIGN, SIZE, DURATION: In a pilot study, 165 adult nulligravid women requesting their first IUD between 1 January 2011 and 31 July 2012 were given a free choice between two IUDs with equal frames measuring 32 x 32 mm--the LNG-IUS 52 mg or a copper-releasing IUD. The women were followed for 1 year. PARTICIPANTS/MATERIAL, SETTING, METHODS: The LNG-IUS was chosen by 113 women (68.5%) and the copper IUD by 52 (31.5%). Prior to insertion the women were interviewed concerning their menstrual characteristics and uterine cavity size was measured by 2-D ultrasonography. After insertion the women kept daily records of bleeding and pain for two reference periods of 90 days during the first year (Months 1-3 and 10-12). The correlation between uterine cavity measurements and numbers of days of bleeding/spotting and pain during the reference periods was analysed. Continuation rates were assessed and reasons for discontinuation as well as the effects of baseline participant characteristics on outcomes were analysed in regression models. MAIN RESULTS AND THE ROLE OF CHANCE: Both uterine cavity size and baseline menstrual characteristics prior to IUD insertion predicted the numbers of days of bleeding/spotting and pain in LNG-IUS users. Women with small uterine cavity dimensions reported less bleeding/ spotting in both reference periods and less pain in the second reference period compared with women with larger dimensions. Baseline scanty spontaneous menstrual bleeding prior to LNG-IUS use (OR 9.4, 95% CI 1.7-51.8, P = 0.01) and smoking (OR 7.8, 95% CI 1.8-33.8, P = 0.006) predicted amenorrhoea in the second reference period. Women with baseline dysmenorrhoea reported more pain with both IUDs. Continuation rates and reasons for discontinuation were similar with both IUDs. LIMITATIONS, REASONS FOR CAUTION: No sample size could be calculated to estimate the power as this was a pilot study. As the majority of women chose the LNG-IUS we did not achieve our initial aim of equally sized IUD groups and thus the size of the copper IUD group may have been insufficient to detect differences. WIDER IMPLICATIONS OF THE FINDINGS: These data further encourage promotion of intrauterine contraception among nulligravid women. Routine use of ultrasonography to assess uterine cavity dimensions prior to IUD insertion is not indicated. STUDY FUNDING/COMPETING INTEREST(S): Supported by Helsinki University Central Hospital research funds, the Swedish Cultural Foundation in Finland and Finska Läkaresällskapet, whoprovided funds for J.K. O.H. serves on advisory boards for Bayer Healthcare, Gedeon Richter and MSD Finland (part of Merck & Co. Inc.) and has designed educational events with these companies. S.S. has lectured in educational events at Bayer and MSD Finland (part of Merck & Co. Inc.) and is a member of the Advisory Board for Contraception at MSD Finland. The other authors have no conflicts of interest to declare. TRIAL REGISTRATION NUMBER: www.clinicaltrials.gov, NCT01685164. [ABSTRACT FROM AUTHOR]

STUDY QUESTION What are the regression and hysterectomy rates for women treated with the levonorgestrel-releasing intrauterine system (LNG-IUS) compared with oral progestogens for endometrial hyperplasia (EH)? SUMMARY ANSWER The LNG-IUS achieves higher regression and lower hysterectomy rates than oral progestogens in the treatment of complex and atypical hyperplasia. WHAT IS KNOWN ALREADY The LNG-IUS and oral progestogens are both equally used to treat women with EH. There is uncertainty about whether the LNG-IUS is a better therapy for EH. STUDY DESIGN, SIZE, DURATION This comparative cohort study included 344 women recruited from August 1998 until December 2010. PARTICIPANTS/MATERIALS, SETTING, METHODS Women with complex non-atypical or atypical EH were treated with the LNG-IUS (n = 250) or oral progestogens (n = 94) in a tertiary referral hospital. We evaluated the proportion of women who regressed or underwent hysterectomy after treatment with the LNG-IUS compared with oral progestogens by logistic regression adjusting for confounding. The time from diagnosis to regression was explored through a survival analysis. MAIN RESULTS AND THE ROLE OF CHANCE The follow-up rate was 95.3%. The mean length of follow-up in the two groups was 66.9 ± SD 35.1 months for the LNG-IUS and 87.2 ± SD 45.5 months for the oral progestogen group. Regression of hyperplasia was achieved in 94.8% (237/250) of patients with the LNG-IUS compared with 84.0% (79/94) of patients treated with oral progestogens (adjusted odds ratio (OR) = 3.04, 95% CI 1.36–6.79, P = 0.001). Hysterectomy rates were lower in the LNG-IUS group during follow-up (22.1, 55/250 versus 37.2%, 35/94, adjusted OR = 0.48, 95% CI 0.28–0.81, P < 0.004). Endometrial cancer was diagnosed in 8 (33%) women who had hysterectomy because of a failure to regress to normal histology during follow-up (n = 24). LIMITATIONS, REASONS FOR CAUTION The observational design cannot exclude residual confounding from unmeasured variables. WIDER IMPLICATIONS OF THE FINDINGS In treating EH, LNG-IUS achieves higher regression rates and lower hysterectomy rates than oral progestogens and should be the first-line therapy. Failure to achieve regression carries a high risk of underlying endometrial cancer and hysterectomy is advised. [ABSTRACT FROM PUBLISHER]

BACKGROUND The effects of oral contraceptives (OCs) on mental health are not clear, and no study has been focused on the effects of the levonorgestrel-releasing intrauterine system (LNG-IUS) on mental health. The aim of this study was to analyse the association between the use of OCs and the LNG-IUS and psychological well-being and psychopathology. METHODS The associations between the current use of OCs and the LNG-IUS, and their duration versus mood symptoms [Beck Depression Inventory (BDI)], psychological well-being [(General Health Questionnaire-12 (GHQ-12)] and recent psychiatric diagnoses [(Composite International Diagnostic Interview (CIDI)] were examined among women who participated in the Finnish-population-based Health 2000 study. Analyses were performed on the 30- to 54-year-old sample (n = 2310); some of the analyses were extended to include the younger age group (18- to 54-year-old sample; n = 3223). RESULTS Overall, hormonal contraception was well tolerated with few significant effects on psychological well-being. The length of OC use was inversely associated with some BDI items (‘dissatisfaction, irritability, lost interest in people, earlier waking and lost interest in sex’), and directly associated with ‘worries about one's health’ (BDI) and with a current diagnosis of ‘alcohol dependence’ (CIDI). The current use of the LNG-IUS was inversely associated with ‘earlier waking’ (BDI) and with ‘impaired concentration’ (GHQ), while the length of LNG-IUS use was inversely associated with ‘strain’ (GHQ). CONCLUSIONS The influence of hormonal birth control on mental health is modest and mainly favourable. The length of current OC use seems to have some beneficial effects on mood although the longer the duration of use, the greater the association with a diagnosis of alcohol dependence. Knowledge of the use of hormonal contraception might be of value when assessing psychopathology in women. The cross-sectional design, with partly retrospective data collection, precludes any causal conclusions. [ABSTRACT FROM PUBLISHER]

BACKGROUND: Consecutive use of the levonorgestrel-releasing intrauterine system (LNG-IUS) is increasing. However, little is known about factors that predict the bleeding during consecutive use. The objective of this study was to analyse the possible factors which may predict the bleeding pattern during the first year of use of a second LNG-IUS. [ABSTRACT FROM PUBLISHER]

Background: The levonorgestrel-releasing intrauterine system (LNG-IUS) is a highly effective contraceptive. However, during early months of use unscheduled vaginal bleeding is common, sometimes leading to discontinuation. This study aimed to determine whether intermittent administration of progesterone receptor modulator CDB-2914 would suppress unscheduled bleeding during the first 4 months after insertion of the LNG-IUS.Methods: CDB-2914 150 mg, in divided doses, or placebo tablets, were administered over three consecutive days starting on Days 21, 49 and 77 after LNG-IUS insertion, in a double-blind randomized controlled trial of women aged 19-49 years, newly starting use of LNG-IUS. Daily bleeding diaries were completed for 6 months, and summarized across blocks as percentage days bleeding/spotting (BS%).Results: Of 69 women randomized to receive CDB-2914, and 67 placebo, 61 and 55, respectively, completed the trial. BS% decreased with time in both arms, but showed a much steeper treatment-phase gradient in the placebo arm (P < 0.0001), so that a benefit of CDB-2914 in the 28 days after first treatment (-11% points, 95% CI -19 to -2), converted to a disadvantage by 64 days after the third treatment (+10% points, 95% CI 1-18).Conclusions: The effect of CDB-2914 on BS% was initially beneficial but then by third treatment was disadvantageous. Nevertheless, only 3% (4/136) of all women discontinued LNG-IUS. These findings give insight into possible mechanisms and suggest future research directions. ISRCTN Trial no. ISRCTN58283041; EudraCT no. 2006-006511-72. [ABSTRACT FROM AUTHOR]

Background: We aimed to evaluate the effect of the levonorgestrel-releasing intrauterine system (LNG-IUS) on the uterine vasculature and the endometrium.Methods: The study was a prospective controlled study evaluating the local effects of LNG-IUS compared with the copper intrauterine device (IUD). Forty-seven women carrying LNG-IUS (group A) were compared with 35 women carrying copper IUD in a control group (group B). Clinical measures of menstrual bleeding, endometrial thickness and Doppler flow of the cervical branch of the uterine artery and spiral artery were evaluated and compared between the two groups.Results: Doppler flow in the cervical branch of the uterine artery did not reveal any changes between the groups (resistance index = 0.6 +/- 0.01 in both groups). Endometrial width was significantly thinner in group A (4.1 +/- 0.2 mm) compared with group B (7.3 +/- 0.2 mm) (P < 0.0001). Subendometrial flow in the spiral artery was significantly reduced in 35 women of group A (75%) and in none of group B (P < 0.0001).Conclusions: The present study offers an explanation for the oligomenorrhoea in LNG-IUS users, i.e. a local progestational effect on the endometrium with no change in the blood flow in the uterine artery. This should be presented to the women in the pre-contraceptive counselling in order to lessen the discontinuation rate. [ABSTRACT FROM AUTHOR]