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American Journal of Obstetrics and... Dec 2022The 52-mg levonorgestrel-releasing intrauterine system is an established, long-acting contraceptive option with approved use for up to 7 years.
BACKGROUND
The 52-mg levonorgestrel-releasing intrauterine system is an established, long-acting contraceptive option with approved use for up to 7 years.
OBJECTIVE
The Mirena Extension Trial evaluated the efficacy and safety of the 52-mg levonorgestrel-releasing intrauterine system during extended use beyond 5 and up to 8 years.
STUDY DESIGN
This was a multicenter, single-arm study in the United States, enrolling existing users of the 52-mg levonorgestrel-releasing intrauterine system, aged 18 to 35 years, who have had the system for 4.5 to 5 years. We assessed the contraceptive efficacy (Pearl Index) and cumulative failure rate (using the Kaplan-Meier method) of the 52-mg levonorgestrel-releasing intrauterine system during extended use. We also evaluated bleeding outcomes and adverse events.
RESULTS
Of the 362 participants starting year 6, 243 entered and 223 completed 8 years of 52-mg levonorgestrel-releasing intrauterine system use. Just more than half the participants were parous. The mean (standard deviation) age was 29.2 (±2.9) years, and all participants were aged ≤36 years at the end of year 8. Two pregnancies occurred, both with the device in situ. The year 6 pregnancy was of undetermined location and resolved spontaneously. The pregnancy in year 7 was ectopic and resolved with methotrexate treatment. In both cases, the 52-mg levonorgestrel-releasing intrauterine system was removed and the participants left the trial. For years 6 to 8, the 3-year Pearl Index (95% confidence interval) was 0.28 (0.03-1.00) with a 3-year cumulative failure rate of 0.68% (0.17-2.71). Pearl Indexes for years 6, 7, and 8 were 0.34 (0.01-1.88), 0.40 (0.01-2.25), and 0.00 (0.00-1.90), respectively. The 3-year (years 6-8) ectopic pregnancy Pearl Index was 0.14 (0.00-0.77). We found treatment-emergent adverse events in 249 of 362 participants (68.8%), with 65 (18.0%) events considered to be related to the 52-mg levonorgestrel-releasing intrauterine system. The discontinuation rate was 38.4% (139/362), most commonly because of desire for pregnancy (12.2%, 44/362). During extended use beyond 5 years and up to 8 years, participants reported a decrease in the mean number of bleeding or spotting days with approximately half of the women experiencing amenorrhea or infrequent bleeding. We did not enroll a sufficient number of women using the 52-mg levonorgestrel-releasing intrauterine system for contraception and heavy menstrual bleeding to assess extended use for that indication. At the end of year 8, most (98.7%, 220/223) of the participants who completed the study remained satisfied with the continued use of the 52-mg levonorgestrel-releasing intrauterine system. Of the 31 women who discontinued early because of desire for pregnancy with evaluable data for return-to-fertility analysis, 24 reported a posttreatment pregnancy within 1 year, giving a 12-month return-to-fertility rate of 77.4%.
CONCLUSION
The 52-mg levonorgestrel-releasing intrauterine system, initially approved for 5 years, maintains high contraceptive efficacy, user satisfaction, and a favorable safety profile through 8 years of use. Participants reported 26 posttreatment pregnancies in total, of which 24 occurred in women who had discontinued the 52-mg levonorgestrel-releasing intrauterine system because of a desire for pregnancy. Of note, among women who elected to continue use through 8 years, bleeding patterns remained highly favorable. These findings support continued 52-mg levonorgestrel-releasing intrauterine system use for up to 8 years in women who wish to continue treatment.
Topics: Pregnancy; Female; Humans; Levonorgestrel; Intrauterine Devices, Medicated; Contraceptive Agents, Female; Menorrhagia; Metrorrhagia
PubMed: 36096186
DOI: 10.1016/j.ajog.2022.09.007 -
British Medical Journal Apr 1956
Topics: Female; Floods; Humans; Implosive Therapy; Menorrhagia; Metrorrhagia
PubMed: 13304402
DOI: 10.1136/bmj.1.4973.975 -
Haemophilia : the Official Journal of... May 2016von Willebrand disease (VWD) is the most common congenital bleeding disorder. In women, menorrhagia is the most common bleeding symptom, and is disabling with iron... (Review)
Review
BACKGROUND
von Willebrand disease (VWD) is the most common congenital bleeding disorder. In women, menorrhagia is the most common bleeding symptom, and is disabling with iron deficiency anaemia, high health cost and poor quality of life. Current hormonal and non-hormonal therapies are limited by ineffectiveness and intolerance. Few data exist regarding von Willebrand factor (VWF), typically prescribed when other treatments fail. The lack of effective therapy for menorrhagia remains the greatest unmet healthcare need in women with VWD. Better therapies are needed to treat women with menorrhagia.
METHODS
We conducted a survey of US haemophilia treatment centres (HTCs) and a literature review using medical subject heading (MeSH) search terms 'von Willebrand factor,' 'menorrhagia' and 'von Willebrand disease' to assess the use of VWF in menorrhagia. Analysis was by descriptive statistics.
RESULTS
Of 83 surveys distributed to HTC MDs, 20 (24.1%) provided sufficient data for analysis. Of 1321 women with VWD seen during 2011-2014, 816 (61.8%) had menorrhagia, for which combined oral contraceptives, tranexamic acid and desmopressin were the most common first-line therapies for menorrhagia, whereas VWF was third-line therapy reported in 13 women (1.6%). Together with data from 88 women from six published studies, VWF safely reduced menorrhagia in 101 women at a dose of 33-100 IU kg(-1) on day 1-6 of menstrual cycle.
CONCLUSIONS
This represents the largest VWD menorrhagia treatment experience to date. VWF safely and effectively reduces menorrhagia in women with VWD. A prospective clinical trial is planned to confirm these findings.
Topics: Antifibrinolytic Agents; Contraceptives, Oral; Databases, Factual; Deamino Arginine Vasopressin; Female; Humans; Menorrhagia; Tranexamic Acid; von Willebrand Diseases; von Willebrand Factor
PubMed: 26843404
DOI: 10.1111/hae.12898 -
Women's Health (London, England) Aug 2015Adenomyosis is described as the benign invasion of endometrium into the myometrium, with endometrial glands and stroma surrounded by the hypertrophic and hyperplastic... (Review)
Review
Adenomyosis is described as the benign invasion of endometrium into the myometrium, with endometrial glands and stroma surrounded by the hypertrophic and hyperplastic myometrium. It may affect 20% of female population and most widely seen among perimenopausal and multiparous women. Its etiopathogenesis, diagnosis, clinical findings and current various treatment options will be discussed in this article.
Topics: Adenomyosis; Contraceptive Agents, Female; Drug Implants; Endometrium; Female; Humans; Intrauterine Devices, Medicated; Menorrhagia; Perimenopause; Risk Factors; Women's Health
PubMed: 26315369
DOI: 10.2217/whe.15.60 -
Minnesota Medicine Mar 2012Hysterectomy is widely used for treating a variety of gynecologic conditions. Most hysterectomies are elective and are performed to treat benign indications for which...
Hysterectomy is widely used for treating a variety of gynecologic conditions. Most hysterectomies are elective and are performed to treat benign indications for which there are other effective alternatives. Observational studies are increasingly highlighting the effects of hysterectomy and concomitant oophorectomy on a variety of long-term health outcomes including fracture risk, pelvic floor dysfunction, all-cause mortality, cardiovascular disease, and neurologic function. Individualizing therapy and discussing appropriate alternatives to hysterectomy is an important responsibility for all health care providers.
Topics: Cross-Sectional Studies; Female; Genital Diseases, Female; Humans; Hysterectomy; Leiomyoma; Menorrhagia; Minnesota; Patient Education as Topic; Treatment Outcome; Uterine Artery Embolization; Uterine Neoplasms; Utilization Review
PubMed: 22611818
DOI: No ID Found -
Ugeskrift For Laeger Nov 2020Menorrhagia is a common complication to oral anticoagulant therapy in premenopausal women. Clinical management of menorrhagia poses a clinical dilemma with the need of... (Review)
Review
Menorrhagia is a common complication to oral anticoagulant therapy in premenopausal women. Clinical management of menorrhagia poses a clinical dilemma with the need of weighting bleeding risk against the risk of recurrent thrombosis. In this review, we describe the risk of menorrhagia during oral anticoagulant therapy, with emphasis on the differences between the specific anticoagulant drugs. We critically assess the treatment options for anticoagulant-associated menorrhagia, and we provide a treatment algorithm for the management of anticoagulant-associated menorrhagia.
Topics: Anticoagulants; Female; Humans; Menorrhagia; Thrombophlebitis
PubMed: 33280643
DOI: No ID Found -
Women's Health (London, England) Jan 2016Women with benign heavy menstrual bleeding have the choice of a number of medical treatment options to reduce their blood loss and improve quality of life. The role of... (Review)
Review
Women with benign heavy menstrual bleeding have the choice of a number of medical treatment options to reduce their blood loss and improve quality of life. The role of the clinician is to provide information to facilitate women in making an appropriate choice. Unfortunately, many options can be associated with hormonal side effects, prevention of fertility and lack of efficacy, leading to discontinuation and progression to surgical interventions. Herein, we discuss the various options currently available to women, including antifibrinolytics, nonsteroidal anti-inflammatory preparations, oral contraceptive pills and oral, injectable and intrauterine progestogens. In addition, we describe the more novel option of selective progesterone receptor modulators and their current benefits and limitations.
Topics: Antifibrinolytic Agents; Contraceptives, Oral, Hormonal; Female; Humans; Intrauterine Devices, Medicated; Levonorgestrel; Medroxyprogesterone; Menorrhagia; Norethindrone; Progesterone; Quality of Life; Women's Health
PubMed: 26695687
DOI: 10.2217/whe.15.100 -
Journal of Infection and Public Health May 2023COVID - 19 vaccine can lead to various local and systemic side effects, including menstrual irregularities in women. There is no robust quantitative evidence of the... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
COVID - 19 vaccine can lead to various local and systemic side effects, including menstrual irregularities in women. There is no robust quantitative evidence of the association between the COVID - 19 vaccine and menstrual irregularities. A meta-analysis was performed to estimate the pooled prevalence of a range of menstrual disorders that may occur in women following COVID - 19 vaccination.
METHODS
After searching for epidemiological studies, we systematically performed a meta-analysis on PubMed/Medline, EMBASE, and Science Direct. Sixteen studies were finally included in the study. We estimated the pooled prevalence and corresponding 95 % confidence intervals (CIs) for a group of menstrual disorders, including menorrhagia, polymenorrhea, abnormal cycle length, and oligomenorrhea. Heterogeneity was assessed using the I statistic and the Q test.
RESULTS
Overall, the pooled prevalence of menorrhagia was 24.24 % (pooled prevalence 24.24 %; 95 % CI: 12.8-35.6 %). The pooled prevalence of polymenorrhea was 16.2 % (pooled prevalence: 16.2 %; 95 % CI: 10.7-21.6 %). The pooled prevalence of abnormal cycle length was relatively lower than that of the other disorders (pooled prevalence: 6.6 %; 95 % CI: 5.0-8.2 %). The pooled prevalence of oligomenorrhea was 22.7 % (95 % CI: 13.5-32.0 %).
CONCLUSION
The findings indicate that menorrhagia, oligomenorrhea, and polymenorrhea were the most common menstrual irregularities after vaccination. The findings also suggest that a relatively high proportion of women suffer from menstrual irregularities. Further longitudinal studies are needed to confirm the causal relationship between COVID-19 vaccination and menstrual irregularities.
Topics: Female; Humans; COVID-19; COVID-19 Vaccines; Menorrhagia; Menstruation Disturbances; Oligomenorrhea; Vaccination
PubMed: 36934644
DOI: 10.1016/j.jiph.2023.02.019 -
Women's Health (London, England) Jan 2016Heavy menstrual bleeding (HMB) has significant adverse effects on the quality of life of many women, placing an economic burden on both health services and society at... (Review)
Review
Heavy menstrual bleeding (HMB) has significant adverse effects on the quality of life of many women, placing an economic burden on both health services and society at large. Thus, it is essential that all women with HMB have easy access to the proper diagnostic and therapeutic work-up in an outpatient fashion, avoiding the more time-consuming inpatient management. This new outpatient approach for HMB is one of the latest development of gynecological practice and can offer both diagnostic and therapeutic procedures. This manuscript aims to show the current possibilities of the modern management of HMB, which can be safely and effectively accomplished in the outpatient setting: global and directed endometrial biopsy, levonorgestrel intrauterine system insertion as well as minimally invasive surgical procedures (encompassing a variety of operative hysteroscopic procedures and second-generation endometrial ablation) are described below.
Topics: Antifibrinolytic Agents; Endometrial Ablation Techniques; Endometrium; Female; Humans; Intrauterine Devices, Medicated; Menorrhagia; Minimally Invasive Surgical Procedures; Outcome Assessment, Health Care; Women's Health
PubMed: 26696502
DOI: 10.2217/whe.15.80 -
Hamostaseologie Oct 2022Von Willebrand disease (VWD) is the most common inherited bleeding disorder, which results from a deficiency or dysfunction of von Willebrand factor (VWF). The major...
Von Willebrand disease (VWD) is the most common inherited bleeding disorder, which results from a deficiency or dysfunction of von Willebrand factor (VWF). The major symptoms of patients affected by VWD include mucocutaneous and gastrointestinal bleeding, easy bruising, and prolonged provoked bleeding due to injury or surgery. Although women and men are equally likely to be affected by VWD, women continue to be disproportionately affected by the bleeding challenges. Women with VWD suffer from sex-specific symptoms, such as menorrhagia, and are at higher risk of reproductive problems and recurrent miscarriage. Furthermore, pregnant women with VWD are more likely at higher risk of suffering from primary and secondary peripartal hemorrhage and anemia and the need for transfusions. Despite being affected by gynecologic and obstetrical bleeding, women face multiple barriers in obtaining an accurate diagnosis. This constitutes a problem that needs to be addressed, and early appropriate medical care should be ensured. There are several effective treatment options for women with VWD that can significantly improve their quality of life, including desmopressin, VWF concentrates, hormonal therapy, and antifibrinolytic therapy. During pregnancy, the monitoring of VWF activity levels is essential. The peripartal management depends on the type of VWD and on the measured levels of VWF levels and activity prior to delivery.
Topics: Male; Female; Humans; Pregnancy; von Willebrand Diseases; von Willebrand Factor; Quality of Life; Hemorrhage; Menorrhagia
PubMed: 36323280
DOI: 10.1055/a-1891-9976