Orilissa (elagolix) / Neurocrine, AbbVie - LARVOL DELTA

Bone mineral density with elagolix plus add-back therapy in women with heavy menstrual bleeding and uterine fibroids: open-label and post-treatment results of a 60-month phase 3 trial. (PubMed, AJOG Glob Rep) - P3 | "Premenopausal women aged 18-50 years with HMB associated with uterine fibroids were randomized 2:1 to receive ELA+AB therapy (ELA 300 mg twice daily plus estradiol 1.0 mg/norethindrone acetate 0.5 mg once daily) or placebo during double-blind treatment. The long-term use of ELA+AB therapy was well tolerated, with no new safety signals identified. These findings support the potential of long-term ELA+AB therapy for HMB associated with uterine fibroids."

Clinical • Journal • P3 data • Gynecology • Infectious Disease • Musculoskeletal Diseases • Novel Coronavirus Disease • Orthopedics • Solid Tumor • Uterine Leiomyoma • Women's Health

Potency of oral gonadotropin-releasing hormone antagonist as endometriosis-associated pain novel treatments: An updated meta-analysis of randomized controlled trials. (PubMed, Int J Reprod Biomed) - "Bone mineral density in the spine was significantly lower in the treatment group (p 0.001). This meta-analysis provides updated evidence on Elagolix, Linzagolix, and Relugolix, confirming their effectiveness in managing endometriosis-associated pain, while highlighting important considerations regarding metabolic and bone health."

Journal • Retrospective data • Review • Dyslipidemia • Endometriosis • Gynecology • Musculoskeletal Pain • Pain • Women's Health

ELARIS EM-COC: Study Of Oral Elagolix Tablets In Combination With Combined Oral Contraceptive Capsules/Tablets To Assess Dysmenorrhea Response In Adult Female Participants With Endometriosis And Associated Moderate To Severe Pain (clinicaltrials.gov) - P3 | N=800 | Active, not recruiting | Sponsor: AbbVie | Recruiting ➔ Active, not recruiting

Enrollment closed • Endometriosis • Gynecology • Pain • Women's Health

Generating Control Groups for Organ Impairment Studies: A Case-Study Comparing Statistical and Population Pharmacokinetic-Based Matching Approaches. (PubMed, CPT Pharmacometrics Syst Pharmacol) - "Similarly, the population pharmacokinetic approach used models developed from phase 1 data in healthy participants and found that the results were generally comparable to the in-study results, with differences in geometric mean ratios ranging from -30% to 17% and -24% to 41% for upadacitinib and elagolix, respectively. These analyses demonstrate that both approaches may be viable alternatives to assess the impact of organ impairment on pharmacokinetics."

Journal • PK/PD data • Hepatology • Renal Disease

Prolonged oral GnRH-antagonist administration before euploid embryo transfer in patients with endometriosis: a prospective randomized pilot non-inferiority trial. (PubMed, Reprod Biomed Online) - "Administration of the oral GnRH antagonist elagolix in appropriate doses for 2 months in women with endometriosis before euploid embryo transfer yields highly encouraging outcomes that are equivalent to those achieved with parenteral administration of a GnRH agonist, which could make this a more desired approach in these patients."

Head-to-Head • Journal • Endometriosis • Gynecology • Infertility • Sexual Disorders • Women's Health

Efficacy of Elagolix and Relugolix for the Treatment of Pelvic Pain in Patients With Endometriosis: A Systematic Review. (PubMed, Cureus) - "Importantly, the strongest and most consistent evidence supports the use of relugolix in combination with add-back therapy, which appears to provide sustained efficacy and a more favorable long-term safety profile than monotherapy. Thus, relugolix with hormonal add-back therapy emerges as a safe and effective long-term treatment option for endometriosis-related symptoms, offering significant clinical benefits while mitigating hypoestrogenic side effects."

Clinical • Journal • Review • Endometriosis • Gynecology • Infertility • Musculoskeletal Pain • Pain • Sexual Disorders • Women's Health

Efficacy of Elagolix in Alleviating Endometriosis-Related Symptoms and Reducing Lesion Size: (FIGO 2025) - "Elagolix appears to effectively alleviate endometriosis-related symptoms and lesion size reduction. Preliminary findings support its use as non-surgical management option. Ongoing follow-up will help determine long-term efficacy, recurrence, and fertility impact."

Clinical • Endometriosis • Gynecology • Infertility • Musculoskeletal Pain • Women's Health

A Clinical Trial to Evaluate Efficacy and Safety of Elagolix Tablets in Women With Moderate or Severe Endometriosis-associated Pain (clinicaltrials.gov) - P3 | N=202 | Completed | Sponsor: Nanjing Chia-tai Tianqing Pharmaceutical | N=330 ➔ 202 | Trial completion date: Sep 2026 ➔ Apr 2025 | Trial primary completion date: Sep 2026 ➔ Nov 2024 | Recruiting ➔ Completed

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Endometriosis • Gynecology • Pain • Women's Health

A Study to Evaluate Pregnancy Outcomes in Females Treated With Oral Elagolix Tablets and Capsules (clinicaltrials.gov) - P=N/A | N=173 | Terminated | Sponsor: AbbVie | N=584 ➔ 173 | Trial completion date: Jan 2029 ➔ Jul 2025 | Recruiting ➔ Terminated | Trial primary completion date: Jan 2029 ➔ Jul 2025; Company Decision

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Endometriosis • Gynecology • Women's Health

Brain Blood Flow Responses to Stress: Sex Differences (clinicaltrials.gov) - P4 | N=22 | Completed | Sponsor: University of Wisconsin, Madison | Recruiting ➔ Completed | Trial completion date: Jul 2026 ➔ May 2025

Trial completion • Trial completion date • CNS Disorders • Vascular Neurology

CalOPT: A Specialty Pharmacy-Dietitian Quality Improvement Initiative for Calcium Optimization in Patients with Osteoporosis Risk. (PubMed, Pharmacy (Basel)) - "Patients aged 18 to 90 years old receiving osteoporosis therapy (denosumab, teriparatide, zoledronic acid) or medications that increase bone loss (elagolix, oral prednisone) were provided with a structured assessment and educational intervention. Over half of the store coupons were redeemed. A specialty pharmacy-RDN customized intervention program provides a model for aiding patients to modify calcium intake."

Journal • Osteoporosis • Rheumatology

Oral Gonadotropin-Releasing Hormone Antagonists in the Treatment of Endometriosis: Advances in Research. (PubMed, J Clin Med Res) - "The primary objective of this review is to comprehensively evaluate the clinical efficacy and safety profile of oral GnRH antagonists, specifically elagolix, relugolix, linzagolix, and opigolix, for the management of endometriosis-associated pain. Furthermore, when combined with add-back therapy, these medications enhance treatment safety and contribute to greater patient compliance. Compared to alternative hormonal treatments, oral GnRH antagonists emerge as a particularly promising approach for managing endometriosis."

Journal • Review • Endometriosis • Gynecology • Musculoskeletal Pain • Pain • Women's Health

Pre-IVF Treatment With a GnRH Antagonist in Women With Endometriosis (clinicaltrials.gov) - P3 | N=103 | Completed | Sponsor: Yale University | Active, not recruiting ➔ Completed

Trial completion • Endometriosis • Gynecology • Infertility • Sexual Disorders • Women's Health

Antagonizing the Corticotropin-releasing Hormone Receptor 1 with an Orally Bioavailable Drug Reduces Endometriosis Pain and Associated Adhesions (WCE 2025) - "Materials and Methods Starting 25 days after endometriosis induction by auto-transplantation, rats received orally 10 mg/kg of Drug P, a selective CRHR1 antagonist or vehicle in oyster crackers, or elagolix (14 mg/kg positive control)...Furthermore, the compound effectively minimizes endometriosis-associated adhesions for which no pharmacological treatment options exist. A decrease in mechanical and inflammatory pain represents a clinically relevant finding."

Endometriosis • Gynecology • Pain • Women's Health • IL6 • LEP • TNFA

Cardiovascular Disease Risk in Women With Endometriosis (clinicaltrials.gov) - P1 | N=40 | Recruiting | Sponsor: Yale University | N=17 ➔ 40

Enrollment change • Cardiovascular • Endometriosis • Gynecology • Women's Health

Pharmacologic Interventions for Endometriosis-Related Pain: A Systematic Review and Meta-analysis. (PubMed, Obstet Gynecol) - "This network meta-analysis indicates that leuprolide in combination with combined OCP, elagolix, vitamins C and E, and gestrinone may represent the most effective therapeutic options for alleviating endometriosis-associated pelvic pain, dysmenorrhea, dyspareunia, and nonmenstrual pelvic pain. These findings enhance our understanding of the relative efficacy of treatment strategies for pain associated with endometriosis. Future research should focus on conducting larger-scale and rigorously designed clinical trials within the target patient populations to further validate these results."

Journal • Retrospective data • Endometriosis • Gynecology • Musculoskeletal Pain • Pain • Women's Health

Oral GnRH antagonists for ovulation suppression during ovarian stimulation protocols: systemic review and meta-analysis. (PubMed, J Assist Reprod Genet) - "This is the first systemic review and meta-analysis to examine the usage of oral GnRH antagonists for ovulation suppression during IVF treatments. Our findings suggest the use of oral GnRH antagonists may be beneficial in infertility treatments; however, caution should be taken, as robust establishment of their effectivity and safety in clinical practice is still pending."

Journal • Retrospective data • Review • Infertility • Sexual Disorders

Role of Menopause in Thermoregulation (clinicaltrials.gov) - P4 | N=24 | Recruiting | Sponsor: Penn State University | Not yet recruiting ➔ Recruiting

Enrollment open

Significance of gut breast cancer resistance protein versus organic anion transporting polypeptide 2B1 inhibition on rosuvastatin clinical drug-drug interactions. (PubMed, Drug Metab Dispos) - "Organic anion transporting polypeptide (OATP)2B1 facilitates oral absorption of many drugs including celiprolol, fexofenadine, and rosuvastatin. Strong BCRP inhibition, with a G-value >100, translated to "positive" DDIs, whereas "OATP2B1-alone" inhibitors may lead to "negative" DDIs. For example, ronacaleret and elagolix significantly reduced rosuvastatin area under the curve due to strong OATP2B1 inhibition but weak BCRP inhibition."

Journal • Breast Cancer • Oncology • Solid Tumor • SLCO2B1

Brain Blood Flow Responses to Stress: Sex Differences (clinicaltrials.gov) - P4 | N=26 | Recruiting | Sponsor: University of Wisconsin, Madison | Trial primary completion date: Mar 2025 ➔ Jul 2025

Trial primary completion date • CNS Disorders • Vascular Neurology

An Oral GnRH Antagonist to Treat Mild Autonomous Cortisol Excess (MACE) Due to Adrenal Adenomas in Postmenopausal Women (clinicaltrials.gov) - P4 | N=4 | Terminated | Sponsor: Icahn School of Medicine at Mount Sinai | N=12 ➔ 4 | Recruiting ➔ Terminated; Difficulty recruiting patients

Enrollment change • Trial termination

Pre-IVF Treatment with a GnRH Antagonist in Women with Endometriosis_temp (clinicaltrials.gov) - P3 | N=288 | Recruiting | Sponsor: Yale University | Trial completion date: Jun 2026 ➔ Sep 2026

Trial completion date • Endometriosis • Gynecology • Infertility • Sexual Disorders • Women's Health

Comparison Elagolix vs Depot Leuprolide Prior to Frozen Embryo Transfers in Patients With Endometriosis (clinicaltrials.gov) - P1 | N=30 | Completed | Sponsor: Colorado Center for Reproductive Medicine | Active, not recruiting ➔ Completed

Trial completion • Endometriosis • Gynecology • Infertility • Sexual Disorders • Women's Health

A systematic review and meta-analysis comparing the use of elagolix therapy alone or in combination with add-back therapy to treat women with uterine fibroid associated heavy menstrual bleeding. (PubMed, Gland Surg) - "Compared with the elagolix treatment alone or with add-back therapy, the placebo was superior in terms of less bone mineral density change and a lower incidence of AEs. This study indicated that elagolix alone or in use with add-back therapy can be considered as a satisfactory treatment plan for the majority of patients who are diagnosed with uterine fibroids and HMB; however, the specific treatment plan should also consider patients' physical condition and any adverse reactions to the drug, based on existing research."

Journal • Retrospective data • Gynecology • Solid Tumor • Uterine Leiomyoma • Women's Health

Role of Menopause in Thermoregulation (clinicaltrials.gov) - P4 | N=24 | Not yet recruiting | Sponsor: Penn State University

New P4 trial