Treatment Of Heavy Menstrual Bleeding Research Articles

The measurement properties of the menorrhagia multi‐attribute quality‐of‐life scale: a psychometric analysis

Menorrhagia, or heavy menstrual bleeding (HMB), is a common gynaecological condition. As the aim of treatment is to improve women's wellbeing and quality of life (QoL), it is necessary to have effective ways to measure this. This study investigated the reliability and validity of the menorrhagia multi-attribute scale (MMAS), a menorrhagia-specific QoL instrument. Participants (n = 431) completed the MMAS and a battery of other tests as part of the baseline assessment of the ECLIPSE (Effectiveness and Cost-effectiveness of Levonorgestrel-containing Intrauterine system in Primary care against Standard trEatment for menorrhagia) trial. Analyses of their responses suggest that the MMAS has good measurement properties and is therefore an appropriate condition-specific instrument to measure the outcome of treatment for HMB.

Thermal balloon ablation versus laparoscopic supracervical hysterectomy for the surgical treatment of heavy menstrual bleeding: A randomized study

To compare postoperative outcomes and effects on quality of life following thermal balloon ablation (TBA) or laparoscopic supracervical hysterectomy (LSH) in women with heavy menstrual bleeding (HMB). Sixty-eight women requiring surgical treatment for HMB were randomly allocated into two treatment arms: TBA (n = 34) and LSH (n = 34). The randomization procedure was based on a computer-generated list. The primary outcome was a comparison of the effects on menstrual bleeding (Pictorial Blood Loss Assessment Chart [PBAC]) between the two procedures. The secondary outcome measures were quality of life, improvement of bleeding patterns, intensity of postoperative pain, and early postoperative complications. Continuous outcome variables were analyzed using Student's t-test. Discrete variables were analyzed with the χ2 test or Fisher's exact test. P < 0.05 was considered statistically significant. The PBAC score was significantly reduced in both treatment groups. After LSH all women had amenorrhea. After TBA there was a significant improvement of bleeding frequency and length. The postoperative pain intensity at 24 h was significantly minor in women treated with TBA rather than with LSH. The Medical Outcomes Survey Short Form 36 (SF-36) score improved in both groups. However, LSH showed a negative impact on the emotional state. No intraoperative complications occurred, and no case was returned to the theatre in either group. The effectiveness of TBA as a possible treatment of HMB is confirmed. However, LSH showed a definitive improvement of the symptoms, and a better life quality profile. Further controlled prospective studies are required for identifying the best surgical approach in women with HMB.

Effective treatment of heavy and/or prolonged menstrual bleeding with an oral contraceptive containing estradiol valerate and dienogest: a randomized, double-blind Phase III trial

This double-blind trial investigated the efficacy and safety of estradiol valerate/dienogest (E(2)V/DNG) for the treatment of heavy menstrual bleeding without recognizable organic pathology. Otherwise healthy women with idiopathic heavy, prolonged or frequent menstrual bleeding, confirmed during a 90-day run-in phase, were randomized (2:1) according to a permuted-block, computer-generated schedule to E(2)V/DNG or placebo for 196 days at 34 centres in Europe and Australia. The primary efficacy end-point was the proportion of women with a 'complete' response (i.e. a return to 'menstrual normality') during a 90-day efficacy phase. Secondary end-points included changes in measured menstrual blood loss (MBL) and iron metabolism parameters. The intention-to-treat population comprised 231 women. The E(2)V/DNG response rate was much higher than with placebo (P < 0.0001). The mean reduction in MBL volume in E(2)V/DNG recipients was 69.4% (median 79.2%) versus 5.8% (median 7.4%) in placebo recipients. The between-treatment difference in MBL volume was 373 ml in favour of E(2)V/DNG (95% confidence interval 490, 255 ml; P < 0.0001). Significant improvements in iron metabolism parameters were observed with E(2)V/DNG but not placebo. Overall, 14 women (9.7%) treated with E(2)V/DNG and 5 (6.2%) treated with placebo prematurely discontinued treatment because of adverse events, headache being the most prevalent. Serious adverse events occurred in both the E(2)V/DNG and placebo groups (each n = 2). E(2)V/DNG is an effective treatment in women with heavy and/or prolonged menstrual bleeding without organic pathology. Further study of E(2)V/DNG compared with an active comparator is warranted. ClinicalTrials.gov identifier: NCT00307801.

Tranexamic Acid: A Novel Oral Formulation for the Treatment of Heavy Menstrual Bleeding

Tranexamic acid, a synthetic lysine derivative, is an antifibrinolytic drug that prevents the breakdown of fibrin by competitively blocking binding sites of plasminogen. Tranexamic acid is often considered a first-line treatment for the management of heavy menstrual bleeding (HMB). A new oral formulation of tranexamic acid provides a nonhormonal HMB therapy that is safe, effective and well tolerated; is administered only during menstruation; addresses the excessive fibrinolysis implicated in many cases of HMB; and improves women's health-related quality of life by reducing limitations on physical, social and leisure activities. This article provides a summary of the clinical development, therapeutic efficacy and tolerability profile of this novel formulation of tranexamic acid for the treatment of HMB.

Hysterectomy, endometrial ablation, and levonorgestrel releasing intrauterine system (Mirena) for treatment of heavy menstrual bleeding: cost effectiveness analysis

Objective To undertake a cost effectiveness analysis comparing first and second generation endometrial ablative techniques, hysterectomy, and the levonorgestrel releasing intrauterine system (Mirena) for treating heavy menstrual bleeding.Design Model based...

Tranexamic Acid Treatment for Heavy Menstrual Bleeding: A Randomized Controlled Trial

Tranexamic Acid Treatment for Heavy Menstrual Bleeding: A Randomized Controlled Trial

Effective Treatment of Heavy Menstrual Bleeding With Estradiol Valerate and Dienogest: A Randomized Controlled Trial

Effective Treatment of Heavy Menstrual Bleeding With Estradiol Valerate and Dienogest: A Randomized Controlled Trial

Tranexamic Acid Treatment for Heavy Menstrual Bleeding: A Randomized Controlled Trial

Ospedaliero-Universitaria Diagnostica Ematochimica, Dipartimento di Patologia e Medicina di Laboratorio, Azienda Ospedaliero-Universitaria di Parma, Parma, Italy; Ospedaliero-Universitaria di Pronto Soccorso e Medicina d'Urgenza, Azienda Ospedaliero-Universitaria di Parma, Parma, Italy; Servizio di Immunoematologia e Medicina Trasfusionale, Dipartimento di Patologia e Medicina di Laboratorio, Azienda Ospedaliero-Universitaria di Parma, Parma, Italy Financial Disclosure: The authors did not report any potential conflicts of interest.

Menorrhagia Impact Questionnaire: assessing the influence of heavy menstrual bleeding on quality of life

Objective:Menorrhagia, or heavy menstrual bleeding (HMB), has a negative impact on women’s quality of life (QOL). The objective was to develop, validate, and assess the performance of a disease-specific patient-reported outcome (PRO) measurement instrument for HMB (the Menorrhagia Impact Questionnaire [MIQ]).Research design and methods:The MIQ was designed to measure the effect of HMB on a woman’s self-assessment of menstrual blood loss (MBL), limitations in social/leisure activities, physical activities, and ability to work. Meaningfulness of these observed MBL changes were also measured. The development and psychometric validation of the MIQ was performed utilizing data from a long-term safety study of tranexamic acid (Lysteda*Lysteda is a registered trade name of Ferring Pharmaceuticals Inc., Parsippany, NJ, USA.), with comparison to an age-matched normal control group recruited from the general population. Performance of the MIQ was also evaluated using data from a six-cycle, randomized, double-blind, clinical study of tranexamic acid for the treatment of HMB. Correlations and sensitivity of each pertinent MIQ item to the treatment-induced changes in MBL were assessed, and the minimally important differences (MID) for the individual MIQ items were determined.Results:The psychometric properties of the MIQ were fully validated. Correlations between individual MIQ items and changes in MBL were statistically significant (p < 0.001). A clear differentiation between tranexamic acid and placebo groups confirmed sensitivity of the MIQ and its ability to detect treatment-induced changes in MBL. MIDs were estimated for the individual MIQ items, with sensitivities and specificities in the 64–79% and 63–82% ranges using receiver operating characteristic (ROC) curve analyses, respectively. MIDs were found to be equal to or greater than 0.5. Statistically significant treatment differences were also observed for the proportions of subjects achieving at least 1-point improvement in MIQ scores.Conclusion:The MIQ contains validated constructs important to women with HMB.Clinical trial registration: NCT00113568 and NCT00386308 (ClinicalTrials.gov ID)Trial registration: ClinicalTrials.gov identifier: NCT00113568.Trial registration: ClinicalTrials.gov identifier: NCT00386308.

Treatment of heavy menstrual bleeding with a new combination of estradiol valerate and dienogest

The first combined oral contraceptive (OC) was launched in the US 50 years ago and was followed by another formulation introduced in Germany one year later. The most common estrogen component in current formulations is ethinylestradiol; however many concerns have been raised with respect to this estrogen. Although the natural estrogen produced by the ovary 17-beta estradiol is the most potent of the estrogens it is poorly absorbed orally and previous attempts to use it in combined OCs have been unsuccessful due to the occurrence of irregular bleeding. Recently a new combined OC was developed containing a natural estrogen estradiol valerate and a new progestin dienogest in a dynamic 26-day four-phasic (estrogen stepdown and progestin stepup) scheme of administration. In clinical trials its contraceptive performance was excellent with good cycle control and bleeding patterns compared with other combined OCs or with placebo. This review focuses predominantly on the use of an estradiol valerate-dienogest combined OC for the treatment of heavy menstrual bleeding. The findings of two large randomized controlled trials have shown that this combined OC constitutes an effective treatment for women with heavy menstrual bleeding representing a new therapeutic option to reduce menstrual blood loss. Further studies are necessary to confirm these data.

Levonorgestrel-releasing intrauterine system for the management of heavy menstrual bleeding in women with inherited bleeding disorders: long-term follow-up

Background There are currently limited data on the use of the levonorgestrel-releasing intrauterine system (LNG-IUS) for the management of heavy menstrual bleeding (HMB) in women with inherited bleeding disorders (IBDs) particularly on its long-term (>12 months) efficacy. Study Design This study involves a case series of women with IBDs who received the LNG-IUS as treatment for HMB. Menstrual blood loss before its insertion and at the time of follow-up was assessed by the pictorial blood-loss assessment chart (PBAC) and hemoglobin (Hb) concentrations. A questionnaire was used to evaluate quality of life (QOL) during menstruation before and after insertion of the LNG-IUS. Results Twenty-six women were included. The median duration of LNG-IUS use at follow-up was 33 months (range, 14–103). The median PBAC score decreased from 255 (range, 134–683) to 35 (range, 0–89) with LNG-IUS use. The median Hb concentrations (11.2 to 13.2 g/dL) and QOL scores (median, 26 to 52) improved significantly with LNG-IUS use (p<.01). Conclusion The LNG-IUS appears to be an effective long-term treatment for HMB in women with IBDs.

Acceptability of the levonorgestrel intrauterine system in the long-term treatment of heavy menstrual bleeding: how many women choose to use a second device?

Objective To assess the acceptability of the levonorgestrel-releasing intrauterine system (LNG-IUS, Mirena ®) in the long-term treatment of heavy menstrual bleeding. Study design Retrospective study of all consecutive women who had a LNG-IUS inserted for control of idiopathic heavy menstrual bleeding between January 2000 and December 2003. Duration of use, reasons for early removal, number of devices removed after 5 years of use, and number of women who decided to use a second LNG-IUS were assessed. Results Of a total of 216 devices inserted, 129 (59.7%) were removed after 5 years of use, 68 (31.5%) were removed anytime before the completion of 5 years, and the remaining 19 (8.8%) patients were lost to follow-up. In 32 of the 68 cases (47.1%) with early removal of the LNG-IUS, the main reason for discontinuation was the appearance of the menopause. After the 5-year effective lifetime of the LNG-IUS, 51 of the 129 women (39.5%) chose to have a second device inserted. Of the 78 women who completed the 5-year treatment period and did not decide to use the LNG-IUS again, 71 (91%) had reached the menopause. Conclusion The LNG-IUS was well accepted by women with idiopathic heavy menstrual bleeding as shown by 39.5% of users (or 87.9% if menopausal women are excluded) deciding to use a second device when the first LNG-IUS expired after 5 years of use.

Thorough cardiac QTc interval conductance assessment of a novel oral tranexamic acid treatment for heavy menstrual bleeding

Objective: To assess the effect of a novel oral tranexamic acid treatment on cardiac repolarization in a randomized, double-blind, positive- and placebo-controlled, four-treatment single-dose cross-over inpatient study.Methods: QTc interval and drug exposure relationship analyses were performed using triplicate digital electrocardiographs (ECGs) collected from 12-lead Holter monitors from healthy females (n = 48) with plasma drug concentrations and pharmacokinetics simultaneously evaluated over 24 h post-dose. Therapeutic (1.3 g) and supratherapeutic (3.9 g) tranexamic acid modified immediate-release doses, a positive-control 0.4 g moxifloxacin dose, and a placebo-control were administered at each period.Results: All post-dose, time-matched, baseline-adjusted, mean QTcF (Fridericia's heart rate correction, QT/RR1/3) treatment-placebo differences (ΔΔQTcF), were less than 5 milliseconds (ms) for the 1.3 g and 3.9 g tranexamic acid doses. Upper limits of the 95% confidence interval (CI) for all tranexamic acid-placebo ΔΔQTcF doses were < 10 ms for all time points. Lower limits of the 95% CI for the positive-control (moxifloxacin-placebo) ΔΔQTcF were > 5 ms at multiple time points demonstrating assay sensitivity. No correlation between tranexamic acid plasma concentrations and adjusted QTc intervals was observed. A positive linear relationship was observed for moxifloxacin (p < 0.01).Conclusion: Cardiac repolarization is not influenced by tranexamic acid at the doses studied.

Levonorgestrel Intrauterine System: A First-Line Medical Treatment for Heavy Menstrual Bleeding

Chronic heavy menstrual bleeding is a common gynecologic condition that causes significant health problems and negatively impacts a woman's quality of life. Surgical treatments should be reserved for women who have pelvic pathology and for those who fail medical therapy. The recent US FDA approval of the levonorgestrel-releasing intrauterine system as an indicated treatment for heavy menstrual bleeding in women who want to use intrauterine devices for birth control highlights the potential that this top tier contraceptive method offers as a first-line therapy for treatment of this problem in women of any reproductive age, without sacrificing their future fertility.

Clinical outcomes from a randomised comparison of Microwave Endometrial Ablation with Thermal Balloon endometrial ablation for the treatment of heavy menstrual bleeding

Clinical outcomes from a randomised comparison of Microwave Endometrial Ablation with Thermal Balloon endometrial ablation for the treatment of heavy menstrual bleeding

A randomized prospective trial comparing the levonorgestrel-releasing intrauterine system with thermal balloon ablation for the treatment of heavy menstrual bleeding

Background Use of the levonorgestrel-releasing intrauterine system (LNG-IUS) was compared with thermal balloon ablation (TBA) for the treatment of heavy menstrual bleeding (HMB). Study Design A prospective randomized trial comparing the LNG-IUS ( n=30 women) and TBA ( n=28 women). Results 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). Conclusions Both the LNG-IUS and TBA appear to be effective in controlling HMB; however, posttreatment uterine bleeding patterns are different.

Oral contraceptive pill for heavy menstrual bleeding

Menorrhagia (heavy menstrual bleeding) is a benign yet debilitating social and health condition. Treatments prescribed in order to reduce excessive menstrual blood loss include prostaglandin synthetase inhibitors, antifibrinolytics, the oral contraceptive pill and other hormones. The combined oral contraceptive pill (OCP) is claimed to have a variety of beneficial, inducing a regular shedding of a thinner endometrium and inhibiting ovulation thus having the effect of treating menorrhagia and providing contraception. To determine the effectiveness of oral contraceptive pills compared with other medical therapies, placebo or no therapy in the treatment of heavy menstrual bleeding. We searched the Menstrual Disorders and Subfertility Group trials register (search dates: Oct 1996, May 2002, June 2004, April 2006 and June 2009) for all publications which describe randomised trials of OCP for the treatment of menorrhagia. This register is based on regular searches of MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials (CENTRAL), PsycINFO, the hand searching of 20 relevant journals and conference proceedings, and searches of several key grey literature sources. All randomised controlled comparisons of OCP versus other medical therapies, placebo or no treatment for the treatment of menorrhagia. Women of reproductive years with regular heavy periods, measured either objectively or subjectively and greater than, or equal to, two months follow up. All assessments of trial quality and data extraction were performed unblinded by at least two reviewers. Only one trial of 45 women met the inclusion criteria and none were excluded. As the trial used a cross-over design, only data from the first treatment period (cycles three and four) were analysed. The results from all the three mefenamic acid groups were combined. There was no significant difference in menstrual blood loss (MBL) between those women treated with the OCP and danazol, mefenamic acid or naproxen. One small study found no significant difference between groups treated with OCP, mefenamic acid, low dose danazol or naproxen. Overall, the evidence from the one study is not sufficient to adequately assess the effectiveness of OCP.This review was unable to achieve its stated objectives because of the paucity of the data.

Repeat use of the LNG-IUS: results of a European multicenter prospective study

OBJECTIVE: Levonorgestrel-releasing intrauterine system (LNG-IUS) is increasingly used for contraception, treatment of heavy menstrual bleeding and endometrial protection during hormone replacement therapy. LNG-IUS has been available in most European countries since early / mid 1990's. Due to its high acceptability and efficacy, many women opt for consecutive use of the LNG-IUS. However, published data on the repeated use of the LNG-IUS is limited. DESIGN: Prospective single group multicenter study performed in four European countries. MATERIALS AND METHODS: Fertile aged women who had used their 1st LNG-IUS between 4 years and 3-9 months and who opted for an immediate insertion of a 2nd IUS. The main outcome measure was the bleeding profile of the 2nd LNG-IUS during its first year of use. Additionally, the acceptability, efficacy and safety of the LNG-IUS was assessed. Bleeding data were recorded on a daily basis and analyzed per 90-day reference period (RF). The bleeding data obtained during the last 90 days of the 1st IUS (baseline) and the first 4 RFs after insertion of the second Mirena were analyzed descriptively. RESULTS: Median age of the 204 subjects that entered the study was 39 years (range 23-45), and median number of births was 2 (range 0-4). 191 subjects (93.6%) completed the study. The median number of bleeding/spotting days at baseline was 7 (25th to 75th percentiles 0-15). Due to bleeding associated with the insertion procedure, this increased to 8 days (range 4-18) during the 1st RF, thereafter decreasing to 4 days (range 0-10/11) during the 2nd - 4th RF. One expulsion and no pregnancies, pelvic inflammatory diseases or perforations occurred. A total of 12 subjects (5.9%) prematurely discontinued the study: 5 due to an adverse event and 7 due to other reasons (incl. loss to follow-up). CONCLUSIONS: This study confirms the favourable bleeding profile, high acceptability, efficacy and safety of repeat use of the LNG-IUS.

Levonorgestrel intrauterine system and medroxyprogesterone acetate for treatment of heavy menstrual bleeding

Levonorgestrel intrauterine system and medroxyprogesterone acetate for treatment of heavy menstrual bleeding

Feasibility of endometrial assessment after thermal ablation

Objective To evaluate the feasibility of endometrial assessment after endometrial thermal ablation. Study design Prospective observational study. A total of 57 women (age 47–52 years), who had undergone endometrial thermal ablation as a treatment for heavy menstrual bleeding (HMB) 3–10 years (mean 6 years) earlier, were examined with transvaginal ultrasound and saline sonohysterography. Endometrial samples were collected with a Pipelle device. Visualisation of endometrium, access to uterine cavity, change in cavity length, success in outpatient endometrial sampling and success in sonohysterography were evaluated. Results Endometrial thickness was 4.5 mm in amenorrhoeic women ( n = 17), 5.6 mm in eumenorrhoeic women ( n = 37) and 6.6 mm in hypermenorrhoeic women ( n = 3). An endometrial sample was successfully taken in 44 (77%) women, and in 13 (23%) women endometrial sample taking failed. The length of the uterine cavity compared to the length measured before endometrial thermal ablation was 0.5–5 cm (mean 2 cm) shorter in 34 women, unchanged in four women and longer in five women. The uterine cavity distended regularly in only nine (16%) women. In 14 (25%) women the cavity distended irregularly or only partly, and in 24 (42%) women the uterine cavity did not distend at all, but appeared as a narrow tube. In 10 (18%) women the sonohysterography catheter did not enter the uterine cavity at all. Conclusion Endometrial assessment is compromised after previous endometrial thermal ablation. Both endometrial sampling and sonohysterography fail quite often, causing problems in diagnosis of abnormal bleeding. Intrauterine adhesions may also decrease the reliability of the endometrial sampling.