Relugolix Combination Therapy for Uterine Leiomyoma-Associated Pain in the LIBERTY Randomized Trials
CONCLUSION: Over 24 weeks, relugolix-CT significantly reduced moderate-to-severe uterine leiomyoma-associated pain with a more pronounced effect on menstrual pain. These data support that relugolix-CT had clinically meaningful effects on women's experience of uterine leiomyoma-associated pain.CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov: LIBERTY 1, NCT03049735; LIBERTY 2, NCT03103087.FUNDING SOURCE: Myovant Sciences GmbH.PMID:35675604 | DOI:10.1097/AOG.0000000000004787 (Source: Obstetrics and Gynecology)
Source: Obstetrics and Gynecology - June 8, 2022 Category: OBGYN Authors: Elizabeth A Stewart Andrea S Lukes Roberta Venturella Juan-Camilo Arjona Ferreira Yulan Li Elke Hunsche Rachel B Wagman Ayman Al-Hendy Source Type: research
70 Effects of relugolix combination therapy on endometriosis-associated pain and analgesic use in spirit studies: overall study and european populations
Introduction and aims: SPIRIT 1&2 were Phase 3, randomized, double-blind, placebo-controlled studies of relugolix combination therapy (Relugolix-CT: relugolix 40mg, estradiol 1mg, norethindrone acetate 0.5mg) in women with endometriosis-associated pain. Changes in analgesic (including opioid) use in pooled SPIRIT overall and European populations are reported. Methods: Premenopausal women with surgically-diagnosed endometriosis, moderate-to-severe dysmenorrhea and non-menstrual pelvic pain (NMPP) were randomized 1:1:1 to 24 weeks of Relugolix-CT, delayed Relugolix-CT (relugolix 40mg monotherapy then Relugolix-CT, 12 weeks e...
Source: European Journal of Obstetrics, Gynecology, and Reproductive Biology - March 1, 2022 Category: OBGYN Authors: R. Venturella, S. As-Sanie, J. Kotarski, C. Mehedintu, S. Imm, A. Qurratul, C. Becker Source Type: research
69. Relugolix combination therapy in European women with symptomatic uterine fibroids in the liberty long-term extension (lte) study
Introduction and aims: In LIBERTY 1&2, once-daily relugolix combination therapy (Relugolix-CT; 40mg relugolix, estradiol 1mg, norethindrone acetate 0.5mg) improved uterine fibroid (UF)-associated heavy menstrual bleeding (HMB) versus placebo, was well tolerated, with preservation of bone mineral density (BMD) through 24 weeks. In LIBERTY LTE, MBL reduction was sustained with no new safety signals and BMD maintenance through 52 weeks. A descriptive subgroup analysis of European vs overall population is reported. (Source: European Journal of Obstetrics, Gynecology, and Reproductive Biology)
Source: European Journal of Obstetrics, Gynecology, and Reproductive Biology - March 1, 2022 Category: OBGYN Authors: R. Venturella, A. Al-Hendy, T. Nyirady, W. Decleer, X. Zhao, L. McKain, V. Rakov, F. Petraglia Source Type: research
An evaluation of relugolix/estradiol/norethindrone acetate for the treatment of heavy menstrual bleeding associated with uterine fibroids in premenopausal women
Expert Opin Pharmacother. 2022 Jan 24:1-9. doi: 10.1080/14656566.2022.2030705. Online ahead of print.ABSTRACTINTRODUCTION: Uterine Fibroids (UFs) are the most predominant benign tumor in women who are coming of reproductive age, and causes intense economic load priced in billions of US dollars. Historically, surgery has been the main definitive treatment, albeit less attractive nowadays, especially for women with future fertility plans. Therefore, studies to explore the pharmacological treatment options are increasing especially as those that are currently available are limited for short-term use only.AREAS COVERED: This d...
Source: Expert Opinion on Pharmacotherapy - January 24, 2022 Category: Drugs & Pharmacology Authors: Mohamed Ali Hsin-Yuan Chen Yi-Fen Chiang Osama A Badary Shih-Min Hsia Ayman Al-Hendy Source Type: research
Population Pharmacokinetics of Elagolix in Combination with Low-Dose Estradiol/Norethindrone Acetate in Women with Uterine Fibroids
ConclusionsElagolix population pharmacokinetics modeling did not reveal any patient-related factors or clinical parameters that would require dose adjustments for the approved dosage of 300 mg twice daily with estradiol 1 mg /norethindrone acetate 0.5 mg daily, in women with heavy menstrual bleeding associated with uterine fib roids.Clinical Trial RegistrationClinicalTrials.gov identifiers: NCT01620528 (EM-1), NCT01760954 (EM-1-Extend), NCT01931670 (EM-2), NCT02143713 (EM-2-Extend), NCT02654054 (UF-1), NCT02691494 (UF-2), NCT0295494 (UF-Extend). (Source: Clinical Pharmacokinetics)
Source: Clinical Pharmacokinetics - December 8, 2021 Category: Drugs & Pharmacology Source Type: research
Current approaches to overcome the side effects of GnRH analogs in the treatment of patients with uterine fibroids
Expert Opin Drug Saf. 2021 Oct 6. doi: 10.1080/14740338.2022.1989409. Online ahead of print.ABSTRACTINTRODUCTION: Uterine fibroids (UFs) are the most prevalent benign neoplastic threat originating from myometria of reproductive age women, with profound financial load valued in hundreds of billions of dollars. Unfortunately, there is no curative treatment so far except surgery and available pharmacological treatments are restricted for short-term treatment options. Thus, there is a large unmet need in the UF space for noninvasive therapeutics.AREAS COVERED: Authors reviewed literature available for the utility of gonadotrop...
Source: Expert Opinion on Drug Safety - October 6, 2021 Category: Drugs & Pharmacology Authors: Mohamed Ali Mohamed Raslan Micha ł Ciebiera Kornelia Zar ęba Ayman Al-Hendy Source Type: research
ADMINISTRATION OF HORMONAL ADD-BACK THERAPY (ABT) COUNTERACTS THE UTERINE VOLUME REDUCING EFFECTS OF ORAL GnRH ANTAGONIST THERAPY
To assess the effect of administration of ABT (estradiol (E2) 1mg/norethindrone acetate 0.5 mg) on uterine volume in women with symptomatic uterine fibroids (UF) receiving the oral GnRH antagonist, linzagolix (LGX). (Source: Fertility and Sterility)
Source: Fertility and Sterility - September 1, 2021 Category: Reproduction Medicine Authors: Jacques Donnez, Hugh S. Taylor, William Catherino, Ayman Al-Hendy, Elke Bestel, Andrew Humberstone, Elizabeth Garner Source Type: research
Relugolix combination therapy improves multiple dimensions of quality of life in women with endometriosis-associated pain: results from the spirit program
Endometriosis has a significant impact on women ’s physical, social, and emotional life. In the SPIRIT trials, relugolix combination therapy (Rel-CT: relugolix 40 mg, estradiol 1 mg, norethindrone acetate 0.5 mg) significantly reduced dysmenorrhea, non-menstrual pelvic pain (NMPP) and dyspareunia vs placebo in premenopausal women with endometri osis-associated pain. Here, the effect of Rel-CT on health-related quality of life (QoL) domains, assessed using the Endometriosis Health Profile (EHP)-30 questionnaire, are reported. (Source: Fertility and Sterility)
Source: Fertility and Sterility - September 1, 2021 Category: Reproduction Medicine Authors: Sawsan As-Sanie, Vandana Mathur, Claudia Mehedintu, So Jung Imm, Qurratul Ann Warsi, Elke Hunsche, Linda C. Giudice Source Type: research
Integrated long-term bone mineral density (bmd) outcomes in women receiving relugolix combination therapy in liberty and spirit studies vs non-treated women
Relugolix combination therapy (Rel-CT [once-daily relugolix 40 mg, estradiol 1 mg, norethindrone acetate 0.5 mg]) is being developed to treat heavy menstrual bleeding associated with uterine fibroids (UF), and endometriosis-associated pain (EM). In the Phase 3 LIBERTY 1/2 trials and long-term extension (LTE) study for UF, Rel-CT maintained BMD through 52 weeks. In the SPIRIT 1/2 trials and LTE study for EM, Rel-CT minimized BMD loss through 24 weeks, after which BMD plateaued up to 52 weeks. Since the mean age of women in the UF studies was higher than that in the EM studies, a pooled population assessment was undertaken t...
Source: Fertility and Sterility - September 1, 2021 Category: Reproduction Medicine Authors: Michael R. McClung, Arthur C. Santora, Ayman Al-Hendy, Neil Johnson, Steven R. Cummings, Juan Camilo Arjona Ferreira, Yulan Li, Rachel B. Wagman Source Type: research
Effects of relugolix combination therapy on bone mineral density through 2 years in women with heavy menstrual bleeding associated with uterine fibroids
Relugolix 40 mg is a non-peptide gonadotropin-releasing hormone receptor antagonist being developed for use in combination with estradiol 1 mg and norethindrone acetate 0.5 mg (relugolix combination therapy; Rel-CT) to treat heavy menstrual bleeding (HMB) associated with uterine fibroids (UF). The rationale for combination therapy is to mitigate anticipated hypoestrogenic effects with relugolix monotherapy, including bone loss. Rel-CT preserved bone mineral density (BMD) in the pivotal LIBERTY 1/2 trials and Long-Term Extension (LTE) study. (Source: Fertility and Sterility)
Source: Fertility and Sterility - September 1, 2021 Category: Reproduction Medicine Authors: Michael R. McClung, Andrea S. Lukes, Roberta Venturella, Arthur C. Santora, Dongmei Zhai, Rachel B. Wagman, Ayman Al-Hendy Source Type: research
Assessment of common adverse events of relugolix combination therapy in premenopausal women treated for symptomatic estrogen-driven conditions: liberty and spirit studies
Relugolix is a once-daily, oral nonpeptide gonadotropin-releasing hormone receptor antagonist being developed in combination with estradiol (E2) and norethindrone acetate (NETA) to treat heavy menstrual bleeding (HMB) associated with uterine fibroids (UF) and moderate-to-severe pain associated with endometriosis (EM). In the Phase 3 LIBERTY 1/2 trials for UF (n=770), relugolix combination therapy (Rel-CT [once-daily relugolix 40 mg, E2 1 mg, NETA 0.5 mg]) reduced HMB vs placebo. In the SPIRIT 1/2 trials for EM (n=1251), Rel-CT reduced dysmenorrhea, non-menstrual pelvic pain and dyspareunia vs placebo. (Source: Fertility and Sterility)
Source: Fertility and Sterility - September 1, 2021 Category: Reproduction Medicine Authors: Ayman Al-Hendy, Sawsan As-Sanie, Juan Camilo Arjona Ferreira, Yulan Li, Rachel B. Wagman, Linda C. Giudice Source Type: research
Liberty randomized withdrawal study: 2-year efficacy and safety of relugolix combination therapy in women with heavy menstrual bleeding associated with uterine fibroids
In the pivotal LIBERTY 1 and 2 trials and Long-Term Extension (LTE) study, once-daily relugolix combination therapy (Rel-CT: relugolix 40 mg, estradiol 1 mg, norethindrone acetate 0.5 mg) reduced menstrual blood loss (MBL) volume and pain in women with uterine fibroids (UF). Rel-CT was well tolerated, with preservation of bone mineral density (BMD) through 52 weeks. Here we report results of the Phase 3 LIBERTY randomized withdrawal study (RWS), designed to evaluate the efficacy and safety of Rel-CT for up to 2 years. (Source: Fertility and Sterility)
Source: Fertility and Sterility - September 1, 2021 Category: Reproduction Medicine Authors: Ayman Al-Hendy, Roberta Venturella, Juan Camilo Arjona Ferreira, Yulan Li, Rachel B. Wagman, Andrea S. Lukes Source Type: research
