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Phase 2, double-blind, randomized, placebo-controlled study of the safety and efficacy of elagolix in women with polycystic ovary syndrome

Open AccessPublished:February 20, 2023DOI:https://doi.org/10.1016/j.xfre.2023.02.007
Phase 2, double-blind, randomized, placebo-controlled study of the safety and efficacy of elagolix in women with polycystic ovary syndrome
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      ABSTRACT

      Objective

      Evaluate the efficacy and safety of elagolix, a GnRH antagonist, to treat polycystic ovarian syndrome (PCOS).

      Design

      A phase 2, multicenter, double-blind, randomized, placebo-controlled trial

      Setting

      35 outpatient and academic medical centers in the United States and Puerto Rico.

      Patients

      114 women with PCOS (aged 18–35 years, body mass index 18.5–38 kg/m2).

      Intervention(s)

      Patients were randomized 2:2:2:2:2:3 to elagolix (25mg twice daily [BID], 50mg once daily [QD], 75mg BID, 150mg QD, and 300mg BID) or placebo.

      Main Outcome Measure(s)

      The primary endpoint was normalization of menstrual cycles (defined as 2 menstrual cycles 21–35 days in length during the 4-month treatment period). The secondary endpoint was change from baseline to week 1 in area under the luteinizing hormone (LH) serum concentration-time curve (AUC). Additional endpoints included change from baseline in serum hormone levels.

      Result(s)

      No significant improvement in restoration of normal menstrual cycles was observed in treated subjects; 3 of 114 patients met the primary endpoint. Six patients experienced progesterone elevations indicative of ovulation. LH levels decreased from baseline to week 16 and LH AUC was significantly reduced from baseline to week 1 in all elagolix treatment groups (P<.1 vs. placebo). Follicle-stimulating hormone (FSH) levels generally remained stable through week 16 with no significant differences in FSH AUCs. Serum estradiol and testosterone concentrations were consistently reduced from baseline in all elagolix dose groups compared with placebo. Adverse event rates were similar across treatment groups.

      Conclusion(s)

      Elagolix treatment did not normalize the ovulatory cycle in patients with PCOS.

      Key Words

      Article info

      Publication history

      Accepted: February 16, 2023
      Received in revised form: February 15, 2023
      Received: December 14, 2022

      Publication stage

      In Press Accepted Manuscript

      Footnotes

      Funding Statement: Financial support was provided by AbbVie, Inc.

      Disclosure Statement: W.D.S. has received research support from AbbVie, and has served as a consultant for AbbVie, including the Uterine Disorders National Steering Committee. M.C.S., J.N., I.A., and M.S. are full-time employees of AbbVie, and may own AbbVie stock or stock options. H.L. is a former employee of AbbVie, and may own AbbVie stock or stock options.

      Data Sharing Statement: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized individual and trial-level data (analysis data sets), as well as other information (eg, protocols, clinical study reports, or analysis plans), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

      This clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing agreement. Data requests can be submitted at any time after approval in the US and Europe and after acceptance of this manuscript for publication. The data will be accessible for 12 months, with possible extensions considered. For more information on the process, or to submit a request, visit the following link: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html.

      Trial Registration: This study was registered at ClinicalTrials.gov (NCT03951077; https://clinicaltrials.gov/ct2/show/NCT03951077). The registration date was May 15, 2019, and the first patient was enrolled on August 12, 2019.

      Clinical Trial Registration: NCT03951077

      Identification

      DOI: https://doi.org/10.1016/j.xfre.2023.02.007

      Copyright

      © 2023 The Authors. Published by Elsevier Inc. on behalf of American Society for Reproductive Medicine.

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