Quality of life improvements in women with uterine fibroids treated with relugolix combination therapy during the LIBERTY long-term extension study: A descriptive subgroup analysis in women with anemia at baseline.

Objective: To investigate the effects of 52 weeks of treatment with relugolix combination therapy (relugolix 40 mg, estradiol 1 mg, norethindrone acetate 0.5 mg) on symptoms of uterine fibroids (UF) and quality of life (QoL) in women with heavy menstrual bleeding associated with UF and anemia (hemoglobin ≤10.5 g/dL) at baseline.

Relugolix combination therapy in Black/African American women with symptomatic uterine fibroids: LIBERTY Long-Term Extension study.

Background: In the LIBERTY Long-Term Extension study, once-daily relugolix combination therapy (40 mg relugolix, estradiol 1 mg, norethindrone acetate 0.5 mg) substantially improved uterine fibroid-associated heavy menstrual bleeding throughout the 52-week treatment period in the overall study population.

Objective: Black or African American women typically experience a greater extent of disease and symptom burden of uterine fibroids vs other racial groups and have traditionally been underrepresented in clinical trials.

A Randomized Open-Label Study of Relugolix Alone or Relugolix Combination Therapy in Premenopausal Women.

Background And Objective: Relugolix is a gonadotropin-releasing hormone receptor antagonist. Relugolix 40-mg monotherapy is associated with vasomotor symptoms and long-term bone mineral density loss due to hypoestrogenism. This study assessed whether the addition of estradiol (E2) 1 mg and norethindrone acetate (NETA) 0.

Quality of life with relugolix combination therapy for uterine fibroids: LIBERTY randomized trials.

Background: Symptomatic uterine fibroids are burdensome to live with; they are associated with symptom-related distress, affect daily activities, and reduce health-related quality of life. The LIBERTY randomized clinical trials showed that oral relugolix combination therapy (40 mg relugolix, 1 mg estradiol, and 0.5 mg norethindrone acetate once daily) markedly improved fibroid-associated symptoms and conditions, including heavy menstrual bleeding, pain, and anemia, and was well-tolerated.

Safety and immunogenicity of an adjuvanted adhesin vaccine in healthy women with and without histories of recurrent urinary tract infections: results from a first-in-human phase 1 study.

Antibiotic resistance among gram-negative bacteria continues to rise globally at an alarming rate. New vaccines that prevent bacterial infections and reduce antibiotic use could provide a potential solution to these problems. This study focused on development of an investigational vaccine to prevent recurrent urinary traction infections (UTI) caused by gram-negative bacteria that use type 1 pili to adhere to, invade, and colonize human bladders.

Three-Year Results of the SONATA Pivotal Trial of Transcervical Fibroid Ablation for Symptomatic Uterine Myomata.

This article reports on 3-year clinical outcomes of the Sonography Guided Transcervical Ablation of Uterine Fibroids (SONATA) pivotal trial of transcervical fibroid ablation (TFA) in women with symptomatic uterine myomata. The SONATA, prospective, controlled, multicenter interventional trial enrolled 147 premenopausal women with symptomatic uterine fibroids who underwent uterus-preserving, sonography-guided TFA with the Sonata System (Gynesonics, Inc., Redwood City, CA, USA).

12-month outcomes of the US patient cohort in the SONATA pivotal IDE trial of transcervical ablation of uterine fibroids.

Objective: The prospective SONATA pivotal Investigational Device Exemption (IDE) trial was performed in the United States (US) and Mexico to examine the safety and effectiveness of transcervical fibroid ablation (TFA) in the treatment of symptomatic uterine fibroids. This is an analysis of 12-month clinical outcomes in the US cohort.

Methods: TFA with the Sonata System was performed on women with symptomatic uterine fibroids.

Health-Related Quality of Life With Ulipristal Acetate for Treatment of Uterine Leiomyomas: A Randomized Controlled Trial.

Objective: To investigate effects of ulipristal acetate on health-related quality of life (QOL) and symptom severity in women with symptomatic uterine leiomyomas and abnormal uterine bleeding.

Methods: Women were randomized to ulipristal (5 mg, 10 mg) or placebo in two phase 3, multicenter, double-blind, placebo-controlled trials (VENUS I and II). Health-related QOL and symptom severity were assessed at baseline, and over one (VENUS I and II) and two (VENUS II) 12-week treatment courses using the Uterine Fibroid Symptom Health-Related Quality of Life questionnaire.

Experience of Symptoms and Disease Impact in Patients with Adenomyosis.

Background: Adenomyosis is a poorly understood, benign disease of the uterus.

Objective: In this study, patient interviews were conducted to characterize the symptoms and impact of adenomyosis.

Methods: This was a cross-sectional study in which women with adenomyosis were recruited from five US clinics and a health-related social network forum.

Elagolix for the management of heavy menstrual bleeding associated with uterine fibroids: results from a phase 2a proof-of-concept study.

Objective: To evaluate the safety and efficacy of elagolix vs. placebo and elagolix with low-dose E/progestogen add-back therapy.

Design: Proof-of-concept, dose-ranging, multiple-cohort study.

Randomized comparative trial of cervical block protocols for pain management during hysteroscopic removal of polyps and myomas.

Purpose: To evaluate the efficacy of two cervical block protocols for pain management during hysteroscopic removal of intrauterine polyps and myomas using the MyoSure(®) device.

Patients And Methods: This was a randomized, comparative treatment trial conducted by five private Obstetrics and Gynecology practices in the USA. Forty premenopausal women aged 18 years and older were randomized to receive either a combination para/intracervical block protocol of 37 cc local anesthetic administered at six injections sites in association with the application of topic 1% lidocaine gel, or an intracervical block protocol of 22 cc local anesthetic administered at three injections sites without topical anesthetic, for pain management during hysteroscopic removal of intrauterine polyps and/or a single type 0 or type 1 submucosal myoma ≤3 cm.

Cost-Effectiveness of Global Endometrial Ablation vs. Hysterectomy for Treatment of Abnormal Uterine Bleeding: US Commercial and Medicaid Payer Perspectives.

Cost-effectiveness modeling studies of global endometrial ablation (GEA) for treatment of abnormal uterine bleeding (AUB) from a US perspective are lacking. The objective of this study was to model the cost-effectiveness of GEA vs. hysterectomy for treatment of AUB in the United States from both commercial and Medicaid payer perspectives.

Cost effectiveness of endometrial ablation with the NovaSure(®) system versus other global ablation modalities and hysterectomy for treatment of abnormal uterine bleeding: US commercial and Medicaid payer perspectives.

Objectives: Abnormal uterine bleeding (AUB) interferes with physical, emotional, and social well-being, impacting the quality of life of more than 10 million women in the USA. Hysterectomy, the most common surgical treatment of AUB, has significant morbidity, low mortality, long recovery, and high associated health care costs. Global endometrial ablation (GEA) provides a surgical alternative with reduced morbidity, cost, and recovery time.

Twelve-month outcomes for patients undergoing hysteroscopic morcellation of uterine polyps and myomas in an office or ambulatory surgical center.

Study Objective: To examine efficacy of hysteroscopic removal of polyps and myomas on health-related quality of life and symptom severity at 1-year postprocedure.

Design: Randomized, prospective, comparative setting clinical trial (Canadian Task Force classification II-2).

Setting: Nine outpatient obstetrics and gynecology practices and hospitals in the United States.

Improved premenstrual syndrome symptoms after NovaSure endometrial ablation.

Study Objective: To evaluate the change in premenstrual syndrome (PMS) symptoms in women with heavy periods who underwent endometrial ablation.

Design: The study used a prospective, single-arm cohort of adult women who were to undergo NovaSure endometrial ablation for heavy menses who also reported symptoms of PMS. A brief baseline survey was done to evaluate menstrual bleeding and baseline PMS symptoms, and two 30-day prospective validated measures of PMS were used.

Estimating a meaningful reduction in menstrual blood loss for women with heavy menstrual bleeding.

Objective: A dichotomy exists within the treatment of heavy menstrual bleeding (HMB); guidelines and expert opinion recommend that clinical management be guided by subjective, patient-centered measures, yet clinical trials often describe treatment efficacy in terms of objective reductions in menstrual blood loss (MBL). The purpose of this investigation was to correlate subjective and objective aspects of HMB treatment by identifying the minimum change in MBL that would be considered meaningful to women.

Research Design And Methods: Receiver operating characteristic (ROC) curve analyses were performed using data from a multicenter, randomized, double-blind, placebo-controlled, parallel-group study of a novel, oral formulation of tranexamic acid (Lysteda).

Tranexamic acid treatment for heavy menstrual bleeding: a randomized controlled trial.

Objective: To assess the efficacy and safety of an oral formulation of tranexamic acid for the treatment of heavy menstrual bleeding.

Methods: Adult women with heavy menstrual bleeding (mean menstrual blood loss 80 mL or more per cycle) were enrolled in a double-blind, placebo-controlled study. After two pretreatment menstrual cycles, women were randomized to receive tranexamic acid 3.

Evolving issues in the clinical and managed care settings on the management of menopause following the women's health initiative.

Background: Publication of the Women's Health Initiative (WHI) trial results in 2002 significantly reduced physician and patient confidence in and acceptance of hormone replacement therapy (HRT) as an appropriate treatment option for menopause-associated vasomotor symptoms (VMS). This was true despite the fact that the WHI trial was a primary prevention study conducted in postmenopausal women and was not designed to evaluate the efficacy of HRT in the treatment of VMS.

Objective: To review data from the WHI, including recent analyses, demonstrating the risks and benefits of HRT in postmenopausal women, to describe changes in menopause treatment guidelines and HRT use since publication of early WHI results nearly 6 years ago, and to identify opportunities for improving the quality of care in perimenopausal women.

Use of the levonorgestrel-releasing intrauterine system in women with hemostatic disorders.

Objective: To evaluate the use of the levonorgestrel-releasing intrauterine system (LNG-IUS) in women with known hemostatic disorders and abnormal uterine bleeding.

Design: Retrospective case series.

Setting: Tertiary medical center.