A randomized clinical trial of a levonorgestrel-releasing intrauterine system and a low-dose combined oral contraceptive for fibroid-related menorrhagia. Levonorgestrel-releasing intrauterine device versus hysteroscopic endometrial resection in the treatment of dysfunctional uterine bleeding. Comparison between antifibrinolytic and antiprostaglandin treatment in the reduction of increased menstrual blood loss in women with intrauterine contraceptive devices. Randomized trial of 2 hormonal and 2 prostaglandin-inhibiting agents in women with a complaint of menorrhagia. A randomized prospective trial comparing the levonorgestrel-releasing intrauterine system with thermal balloon ablation for the treatment of heavy menstrual bleeding. Randomised comparative trial of the levonorgestrel intrauterine system and norethisterone for treatment of idiopathic menorrhagia. Reduction by naproxen of excessive menstrual bleeding in women using intrauterine devices. Role of prostaglandins in IUD-associated uterine bleeding--effect of a prostaglandin synthetase inhibitor (ibuprofen). A randomized controlled trial of levonorgestrel releasing IUD and thermal balloon ablation in the treatment of menorrhagia.
To compare the efficacy of a levonorgestrel-releasing intrauterine system (LNG-IUS) with that of a low-dose combined oral contraceptive (COC) in reducing fibroid-related menorrhagia.
                In this single-center, open, randomized clinical trial, 58 women with menorrhagia who desired contraception were randomized to receive a LNG-IUS or COC. The outcomes included treatment failure, defined as the need for another treatment; menstrual blood loss (MBL) by the alkaline hematin method and a pictorial assessment chart (PBAC); hemoglobin levels; and "lost days."
                Treatment failed in 6 women (23.1%) in the LNG-IUS group and 11 (37.9%) in the COC group, for a hazard ratio of 0.46 (95% CI, 0.17-1.17, P=0.101). Using the alkaline hematin test, the reduction of MBL was significantly greater in the LNG-IUS group (90.9% ± 12.8% vs 13.4% ± 11.1%; P<0.001). Using PBAC scores, the reduction was also significantly greater in the LNG-IUS group (88.0% ± 16.5% vs 53.5% ± 5 1.2%; P=0.02). Moreover, hemoglobin levels increased from 9.7 ± 1.9g/dL to 11.7 ± 1.2g/dL (P<0.001) and lost days decreased from 8.2 ± 3.3 days to 1.3 ± 1.5 days (P=0.003) in the LNG-IUS group.
                Although the rate of treatment failure was similar in both groups, the LNG-IUS was more effective in reducing MBL than the COC in women with fibroid-related menorrhagia.
                Copyright Â© 2010 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved. To compare the effect of a levonorgestrel-releasing intrauterine device with that of endometrial resection on menstrual bleeding, patient satisfaction, and quality of life in menorrhagic women during 12 months of follow-up.
                Seventy premenopausal women with dysfunctional uterine bleeding were enrolled in a prospective, open, parallel-group, controlled trial. They were randomized to either insertion of an intrauterine system releasing 20 micrograms/day of levonorgestrel (n = 35) or endometrial resection (n = 35). The women were evaluated at baseline, and thereafter, uterine bleeding was assessed monthly with a pictorial blood loss assessment chart. Clinical gynecologic examination was performed bimonthly, and the hematologic variables were measured at 6 and 12 months. On the latter occasion, the women were requested to rate the degree of satisfaction with the effect of their treatment and to complete the Short Form 36 General Health Survey questionnaire.
                Recurrent menorrhagia was observed at 12 months in four women in the intrauterine device group (including two with partial expulsion of the device) and in three women in the resection group. Compared with baseline values, at 1 year, the pictorial blood loss assessment chart score was reduced by 79% in the former group and by 89% in the latter. Amenorrhea or hypomenorrhea at 12 months was reported by 65% of the women with an intrauterine device compared with 71% who underwent endometrial resection. The degree of satisfaction with treatment was high in both groups, with 29 of 34 (85%) women being satisfied or very satisfied in the intrauterine device group versus 33 of 35 (94%) in the resection group. Health-related quality of life perception was not significantly different in the two treatment groups.
                Somewhat less satisfactory results were obtained with a levonorgestrel-releasing intrauterine system compared with endometrial resection for dysfunctional uterine bleeding at 1 year of follow-up. The effects of a fibrinolysis inhibitor (tranexamic acid, TA) and prostaglandin synthesis inhibitor (diclofenac sodium, DS) were compared in the reduction of excessive menstrual blood loss in 19 women with an intrauterine contraceptive device (IUCD). These women (mean blood loss before treatment to 135.1 +/- 18.9 SE ml, range 70-294 ml) were treated in random order with TA (1.5 g three times daily for 5 days starting on the first day of menstruation for two periods), and with DS (50 mg three times on the first day followed by 25 mg three times daily for 4 days, for two periods), or with placebo (one period) in a double-blind trial. The placebo treatment did not change menstrual blood loss (128.3 +/- 15.6 ml). The TA treatment decreased blood loss to 59.4 +/- 7.7 ml (P less than 0.001) and the DS treatment to 102.1 +/- 13.6 ml (P less than 0.01). Neither treatment abolished pelvic discomfort during menstruation or shortened its duration. Various side-effects were noted by 12 women during 19 TA treatments and by five women during six DS treatments. Thus, while TA is generally far more effective, DS gave pronounced decreases in menstrual bleeding in some women and had less frequent side-effects. A series of 45 ovulatory women with a complaint of menorrhagia were randomized into 3 treatment groups, before receiving therapy with mefenamic acid in 2 cycles and 1 of 3 other agents in 2 cycles: naproxen (group 1; n = 14), a low dose monophasic combined oral contraceptive (group 2; n = 12) or low dose danazol (group 3; n = 12). Menstrual blood loss was measured in 2-4 control cycles and during therapy. Mefenamic acid reduced measured blood loss by 20%; 38%; and 39% in groups 1-3 respectively. Naproxen reduced blood loss by 12%; the oral contraceptive by 43%; and danazol by 49%. There was no statistically significant difference in blood loss reduction (mean of 2 cycles) between any of the treatments, although women on danazol experienced a dramatic and highly significant further reduction in blood loss after the first treatment cycle (p less than 0.003). These were all effective therapies in a majority of women, but some 'non-responders' were seen in each group. The 'non-responders' had a significantly lower pretreatment blood loss than responders. Several women in group 1 showed anomalous responses to prostaglandin inhibitors with consistent and substantial exacerbation of menorrhagia during therapy. A number of reasonable therapies exist for the medical treatment of menorrhagia, but because none is suitable for everyone management needs to be individualized for each patient. Use of the levonorgestrel-releasing intrauterine system (LNG-IUS) was compared with thermal balloon ablation (TBA) for the treatment of heavy menstrual bleeding (HMB).
                A prospective randomized trial comparing the LNG-IUS (n=30 women) and TBA (n=28 women).
                Hemoglobin levels increased (p<.001) and blood loss was reduced (p<.001) in both groups after 1 year of treatment. Menstrual bleeding was less in the LNG-IUS group compared to the TBA group at 6 and 12 months of treatment (p=.035 and p=.048, respectively). Intermenstrual bleeding was significantly less in the TBA group at 6 months compared to the LNG-IUS group (p=.044); however, there was no significant difference at 12 months (p=.129). No difference was found in psychological aspects between pre- and posttreatment variables in either of the groups (p=.537).
                Both the LNG-IUS and TBA appear to be effective in controlling HMB; however, posttreatment uterine bleeding patterns are different.
                Copyright (c) 2010 Elsevier Inc. All rights reserved. To compare the efficacy and acceptability of the levonorgestrel intrauterine system and norethisterone for the treatment of idiopathic menorrhagia.
                A randomised comparative parallel group study.
                Gynaecology outpatient clinic in a teaching hospital.
                Forty-four women with heavy regular periods and a measured menstrual blood loss exceeding 80 ml.
                Twenty-two women had a levonorgestrel intrauterine system inserted within the first seven days of menses, and 22 women received norethisterone (5 mg three times daily) from day 5 to day 26 of the cycle for three cycles.
                The main outcome measure was the change in objectively assessed menstrual blood loss after three months of treatment.
                When menstrual blood loss at three months was expressed as a percentage of the control, the levonorgestrel intrauterine system reduced menstrual blood loss by 94% (median reduction 103 ml; range 70 to 733 ml), and oral norethisterone by 87% (median reduction 95 ml; range 56 to 212 ml). After three cycles of treatment 76% of the women in the levonorgestrel intrauterine system group wished to continue with the treatment, compared with only 22% of the norethisterone group.
                Both the levonorgestrel intrauterine system and oral norethisterone in this regimen provided an effective treatment for menorrhagia in terms of reducing menstrual blood loss to within normal limits. The levonorgestrel intrauterine system was associated with higher rates of satisfaction and continuation with treatment, and thus offers an effective alternative to currently available medical and surgical treatments for menorrhagia. Thirty-four patients using intrauterine contraceptive devices and experiencing excessive menstrual bleeding (more than 80 ml average loss for 2 cycles) were treated with the prostaglandin synthetase inhibitor naproxen. The trial was conducted according to a double-blind placebo-controlled crossover design. Each patient received 2 of 3 treatments: naproxen in high dose (1250 mg/day for 5 days), naproxen in low dose (500-mg loading dose, than 750 mg/day for 5 days), or placebo. Each treatment was taken during 2 consecutive menstruations. When all data were pooled, statistically significant reduction in menstrual bleeding was found with both high- and low-dose naproxen treatment compared with placebo therapy (P < .002). Low- and high-dose naproxen reduced menstrual blood loss by 22% and 32%, respectively, whereas the change with placebo was minimal. Although the dose had no significant effect on mean menstrual loss, the number of treatment cycles in which menstrual blood loss was reduced by 50% as compared with pretreatment cycles strongly suggested a dose response. In almost 60% of naproxen-treated cycles, mean menstrual blood loss was less than 80 ml, whereas during placebo-treated cycles the distribution of menstrual loss was similar to that of control cycles. Prostaglandins have been shown to be increased in the endometrium of women and experimental animals wearing intrauterine devices (IUDs). As prostaglandins may cause increased vascularity and vascular permeability, and as certain prostaglandins (PgI2) inhibit platelet activity, the local generation of prostaglandins may contribute to endometrial bleeding. Thus, the effect of ibuprofen, a prostaglandin synthetase inhibitor, was tested by quantifying menstrual blood loss in 20 women wearing IUDs in a double-blind, 2-period crossover study. Ibuprofen produced a significant reduction in menstrual blood loss; the percentage reduction was greater in women using a Lippes Loop and who had heavier blood loss (39%) than in women using a copper device and who had lighter blood loss (25%). These findings support the contention that prostaglandin synthesis is important in the genesis of IUD-associated menorrhagia and that prostaglandin inhibitors may be useful in the therapy of this condition. Our aim was to compare the treatment of menorrhagia either with a levonorgestrel-releasing intrauterine device or with endometrial thermal balloon ablation. The primary endpoints of evaluation were menstrual blood flow reduction and the increase in hemoglobin values, while the secondary end points were adverse side effects; health related quality of life. After randomization, 36 women underwent outpatient thermal balloon ablation under local anesthesia and an intrauterine device releasing 20 microgram/day of levonorgestrel, were inserted within the first 7 days of menses to 36 women. Both techniques were found to be significantly effective in reducing the menstrual blood loss but in comparison thermal balloon ablation was more effective in Deltamean +/- SD decrease of pictorial sores (388.2 +/- 21 vs 343 +/- 27; p < 0.001). We noted a significant but similar increases in Deltamean +/- SD hemoglobin values (3.9 +/- 1.7 vs 3.7 +/- 1.4; p:.21). Patients treated by thermal balloon ablation reported fewer side effects and perceived a higher health related quality of life in physical role functioning. At one year of follow-up, the medicated device was effective but not as effective as thermal balloon ablation in reducing the menstrual blood loss. However it was found to be as effective as thermal balloon ablation in increasing the hemoglobin values. The side effect profile of the medicated device may alter its acceptability by reducing the perceived health related quality of life in menorrhagic women with no desire for further childbearing.
Progestogen-releasing intrauterine systems appear to reduce menstrual blood loss in premenopausal women with uterine fibroids. Oral progestogens did not reduce fibroid size or fibroid-
related symptoms. However, there was a methodological limitation and the one included study with data had a small sample size. This evidence is insufficient to support the use of progestogens or progestogen-releasing intrauterine systems in treating premenopausal women with uterine fibroids.