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.

A transmandibular lateral transsphenoidal navigated surgical approach to access a pituitary macroadenoma in a warmblood mare.

A 16-year-old warmblood mare was referred with a progressive history of behavioral changes and left-sided blindness. Following neuroanatomical localization to the forebrain, magnetic resonance imaging of the head revealed a well-delineated, 4.5 cm in diameter, round pituitary mass causing marked compression of the midbrain and optic chiasm.

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.

LIBERTY randomized withdrawal study: relugolix combination therapy for heavy menstrual bleeding associated with uterine fibroids.

Background: In the pivotal LIBERTY 1 and 2 trials and long-term extension study, once-daily relugolix combination therapy (40 mg relugolix, 1 mg estradiol, 0.5 mg norethindrone acetate) reduced menstrual blood loss volume and pain among women with uterine fibroids. Relugolix combination therapy was well tolerated with preservation of bone mineral density through 52 weeks.

A plain language summary of the long-term relugolix combination therapy study for uterine fibroids.

What is this summary about? This is a summary of a research study (known as a clinical trial) called the LIBERTY extension study. The LIBERTY extension study is a long-term study looking at how well a medicine called relugolix combination therapy worked in reducing blood loss during menstrual periods in women with uterine fibroids with heavy menstrual periods. Women were included in the extension study if they finished the 24-week LIBERTY 1 or LIBERTY 2 studies.

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.

Long-term Relugolix Combination Therapy for Symptomatic Uterine Leiomyomas.

Objective: In the LIBERTY 1 and LIBERTY 2 placebo-controlled trials, once-daily relugolix combination therapy reduced menstrual blood loss volume and pain in women with heavy menstrual bleeding associated with uterine leiomyomas and was well tolerated, with preservation of bone mineral density (BMD) through 24 weeks. Here we report the long-term efficacy and safety of relugolix combination therapy treatment for up to 52 weeks.

Methods: Women with uterine leiomyoma-associated heavy menstrual bleeding who completed any treatment arm in either the LIBERTY 1 or LIBERTY 2 trial were eligible to enroll in a 28-week long-term extension study.

Relugolix Combination Therapy for Uterine Leiomyoma-Associated Pain in the LIBERTY Randomized Trials.

Objective: To assess the effect of once-daily relugolix combination therapy (relugolix-CT: relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg) compared with placebo on moderate-to-severe pain in women with uterine leiomyomas and heavy menstrual bleeding.

Methods: Two replicate, multinational, double-blind, 24-week, randomized, phase 3 studies (LIBERTY 1 and 2) were conducted in premenopausal women with uterine leiomyoma-associated heavy menstrual bleeding (80 mL or greater per cycle for two cycles or 160 mL or greater during one cycle).

Paroxysmal otalgia treated with microvascular decompression of the intermediate nerve: illustrative case.

Background: Intermediate nerve neuralgia is a rare type of cranial neuralgia that causes clinical, therapeutic, and diagnostic challenges. Studies have described pharmacological and surgical treatment options. Surgical treatment ranges from sectioning of neural structures to microvascular decompression.

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.

Ulipristal Acetate for Treatment of Uterine Leiomyomas: A Randomized Controlled Trial.

Objective: To assess the efficacy and tolerability of ulipristal acetate, a selective progesterone receptor modulator, for treatment of symptomatic uterine leiomyomas.

Methods: This phase 3, double-blind, double-dummy, placebo-controlled trial randomized premenopausal women (18-50 years) with uterine leiomyomas and abnormal uterine bleeding to once-daily 5 mg ulipristal, 10 mg ulipristal, or placebo in two 12-week treatment courses separated by a drug-free interval of two menses. Coprimary end points were rates of and time to amenorrhea during course 1.

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.

Magnetic Resonance Imaging Signal Characteristics of Medishield: Early Postoperative Profile in a Rabbit Interlaminotomy Model.

Objective: Application of Medishield to the nerve root is common during spinal surgery to create a mechanical barrier from pain mediators and reduce scar formation. However, Medishield's signal characteristics on magnetic resonance imaging (MRI) have not yet been examined.

Methods: Microsurgical interlaminotomy was performed on 2 lower lumbar segments in 17 adult New Zealand white rabbits.

Preservation and Microsurgical Repair of the Superficial Temporal Artery During Pterional Craniotomy.

Objective: To study the rate of superficial temporal artery (STA) preservation and the effectiveness of STA reconstruction in patients undergoing a pterional craniotomy.

Methods: Included patients (n = 136) underwent either an emergency or an elective pterional craniotomy. In case of deliberate transection or accidental damage of the STA, it was repaired microsurgically at the end of the procedure.

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.