{
  "topic": {
    "stem": "RELUGOLIX_FIBROIDS_AUTO_2",
    "name": "Relugolix combo in fibroids",
    "ncts": [
      "NCT02655237",
      "NCT03412890",
      "NCT05862272",
      "NCT02655224",
      "NCT03751124",
      "NCT03103087",
      "NCT03049735",
      "NCT06671548"
    ],
    "drug_patterns": [
      "relugolix"
    ],
    "condition_patterns": [
      "fibroid"
    ]
  },
  "trials": [
    {
      "gates": {
        "A_aact_exists": true,
        "B_drug_in_intvs": true,
        "C_condition_in_aact": true,
        "D_pmid_topic_match": true,
        "E_two_arms": true,
        "F_primary_outcome_known": true
      },
      "extracted": {
        "nct": "NCT02655237",
        "aact_title": "A Phase 3 Study to Evaluate the Efficacy and Safety of Relugolix (TAK-385) 40 mg Compared With Leuprorelin in the Treatment of Uterine Fibroids",
        "aact_acronym": "",
        "start_date": "2016-03-05",
        "primary_completion_date": "2017-05-17",
        "aact_intvs": [
          "relugolix",
          "relugolix placebo",
          "leuprorelin"
        ],
        "aact_conditions": [
          "uterine fibroids"
        ],
        "pmid": "30741797",
        "pubmed_year": 2019,
        "pubmed_doi": "10.1097/AOG.0000000000003141",
        "aact_per_arm_counts": {
          "BG000": 139,
          "BG001": 142
        },
        "aact_primary_outcome_measure": "Percentage of Participants With Total PBAC Score of <10 From Week 6 to 12",
        "aact_outcome_count_rows": [
          [
            "OG000",
            "1.0"
          ],
          [
            "OG001",
            "0.0"
          ],
          [
            "OG000",
            "82.2"
          ],
          [
            "OG001",
            "83.1"
          ],
          [
            "OG000",
            "64.2"
          ],
          [
            "OG001",
            "31.7"
          ],
          [
            "OG000",
            "84.1"
          ],
          [
            "OG001",
            "94.7"
          ],
          [
            "OG000",
            "79.0"
          ],
          [
            "OG001",
            "92.3"
          ]
        ]
      }
    },
    {
      "gates": {
        "A_aact_exists": true,
        "B_drug_in_intvs": true,
        "C_condition_in_aact": true,
        "D_pmid_topic_match": true,
        "E_two_arms": true,
        "F_primary_outcome_known": true
      },
      "extracted": {
        "nct": "NCT03412890",
        "aact_title": "LIBERTY EXTENSION: Efficacy and Safety Extension Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids",
        "aact_acronym": "",
        "start_date": "2017-10-19",
        "primary_completion_date": "2020-01-21",
        "aact_intvs": [
          "relugolix",
          "estradiol/norethindrone acetate"
        ],
        "aact_conditions": [
          "heavy menstrual bleeding",
          "uterine fibroid"
        ],
        "pmid": "37863160",
        "pubmed_year": 2024,
        "pubmed_doi": "10.1016/j.ajog.2023.10.030",
        "aact_per_arm_counts": {
          "BG000": 163,
          "BG001": 149,
          "BG002": 164
        },
        "aact_primary_outcome_measure": "Percentage Of Participants Who Achieved Or Maintained An MBL Volume Of <80 Milliliters (mL) And At Least A 50% Reduction From Baseline MBL Volume At Week 52/End Of Treatment",
        "aact_outcome_count_rows": [
          [
            "OG000",
            "86.5"
          ],
          [
            "OG001",
            "79.87"
          ],
          [
            "OG002",
            "75.0"
          ],
          [
            "OG000",
            "70.55"
          ],
          [
            "OG001",
            "68.46"
          ],
          [
            "OG002",
            "57.93"
          ],
          [
            "OG000",
            "58.97"
          ],
          [
            "OG001",
            "78.95"
          ],
          [
            "OG002",
            "42.11"
          ],
          [
            "OG000",
            "56.0"
          ]
        ]
      }
    },
    {
      "gates": {
        "A_aact_exists": true,
        "B_drug_in_intvs": true,
        "C_condition_in_aact": true,
        "D_pmid_topic_match": false,
        "E_two_arms": false,
        "F_primary_outcome_known": true
      },
      "extracted": {
        "nct": "NCT05862272",
        "aact_title": "A Phase 3B Study to Evaluate Bone Mineral Density With Long-Term Use of Relugolix Combination Tablet in Women With Uterine Fibroids or Endometriosis",
        "aact_acronym": "",
        "start_date": "2023-08-14",
        "primary_completion_date": "2029-07-31",
        "aact_intvs": [
          "relugolix combination tablet"
        ],
        "aact_conditions": [
          "endometriosis",
          "uterine fibroids"
        ],
        "pmid": null,
        "aact_per_arm_counts": {},
        "aact_primary_outcome_measure": "Percent change from baseline in BMD (bone mineral density) at Month 48 on-treatment at lumbar spine (L1-L4) in women with uterine fibroids.",
        "aact_outcome_count_rows": []
      }
    },
    {
      "gates": {
        "A_aact_exists": true,
        "B_drug_in_intvs": true,
        "C_condition_in_aact": true,
        "D_pmid_topic_match": true,
        "E_two_arms": true,
        "F_primary_outcome_known": true
      },
      "extracted": {
        "nct": "NCT02655224",
        "aact_title": "A Placebo-Controlled, Phase 3 Study of Relugolix (TAK-385) 40 mg in the Treatment of Pain Symptoms Associated With Uterine Fibroids",
        "aact_acronym": "",
        "start_date": "2016-03-26",
        "primary_completion_date": "2017-05-16",
        "aact_intvs": [
          "relugolix",
          "relugolix placebo"
        ],
        "aact_conditions": [
          "uterine fibroids"
        ],
        "pmid": "31594635",
        "pubmed_year": 2019,
        "pubmed_doi": "10.1016/j.fertnstert.2019.07.013",
        "aact_per_arm_counts": {
          "BG000": 33,
          "BG001": 32
        },
        "aact_primary_outcome_measure": "Percentage of Participants With a Maximum NRS Score of 1 or Less During the 28 Days Before the Final Dose of Study Drug",
        "aact_outcome_count_rows": [
          [
            "OG000",
            "57.6"
          ],
          [
            "OG001",
            "3.1"
          ],
          [
            "OG000",
            "48.5"
          ],
          [
            "OG001",
            "3.1"
          ],
          [
            "OG000",
            "24.2"
          ],
          [
            "OG001",
            "0.0"
          ],
          [
            "OG000",
            "45.5"
          ],
          [
            "OG001",
            "12.9"
          ],
          [
            "OG000",
            "59.4"
          ],
          [
            "OG001",
            "12.9"
          ]
        ]
      }
    },
    {
      "gates": {
        "A_aact_exists": true,
        "B_drug_in_intvs": true,
        "C_condition_in_aact": true,
        "D_pmid_topic_match": true,
        "E_two_arms": true,
        "F_primary_outcome_known": true
      },
      "extracted": {
        "nct": "NCT03751124",
        "aact_title": "Study of Relugolix With Estradiol and Norethindrone Acetate in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids",
        "aact_acronym": "",
        "start_date": "2018-10-16",
        "primary_completion_date": "2021-02-19",
        "aact_intvs": [
          "relugolix",
          "estradiol/norethindrone acetate",
          "placebo for relugolix"
        ],
        "aact_conditions": [
          "uterine fibroids",
          "uterine leiomyoma"
        ],
        "pmid": "37666383",
        "pubmed_year": 2023,
        "pubmed_doi": "10.1016/j.ajog.2023.08.030",
        "aact_per_arm_counts": {
          "BG000": 115,
          "BG001": 113
        },
        "aact_primary_outcome_measure": "Percentage Of Participants Who Maintained MBL Volume Of <80 Milliliters (mL) At Week 76 During The Randomized Treatment Period",
        "aact_outcome_count_rows": [
          [
            "OG000",
            "78.43"
          ],
          [
            "OG001",
            "15.08"
          ],
          [
            "OG000",
            "69.79"
          ],
          [
            "OG001",
            "11.75"
          ],
          [
            "OG000",
            "57.39"
          ],
          [
            "OG001",
            "13.27"
          ],
          [
            "OG000",
            "58.26"
          ],
          [
            "OG001",
            "10.62"
          ],
          [
            "OG000",
            "96.15"
          ],
          [
            "OG001",
            "97.75"
          ]
        ]
      }
    },
    {
      "gates": {
        "A_aact_exists": true,
        "B_drug_in_intvs": true,
        "C_condition_in_aact": true,
        "D_pmid_topic_match": true,
        "E_two_arms": true,
        "F_primary_outcome_known": true
      },
      "extracted": {
        "nct": "NCT03103087",
        "aact_title": "LIBERTY 2: Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids",
        "aact_acronym": "",
        "start_date": "2017-06-14",
        "primary_completion_date": "2019-07-10",
        "aact_intvs": [
          "relugolix",
          "estradiol/norethindrone acetate",
          "relugolix placebo"
        ],
        "aact_conditions": [
          "heavy menstrual bleeding",
          "uterine fibroid"
        ],
        "pmid": "40320117",
        "pubmed_year": 2025,
        "pubmed_doi": "10.1016/j.fertnstert.2025.04.037",
        "aact_per_arm_counts": {
          "BG000": 126,
          "BG001": 127,
          "BG002": 129
        },
        "aact_primary_outcome_measure": "Percentage Of Participants Who Achieved A Menstrual Blood Loss (MBL) Volume Of < 80 mL And A ≥ 50% Reduction From Baseline MBL Volume With Relugolix Plus E2/NETA",
        "aact_outcome_count_rows": [
          [
            "OG001",
            "5.41"
          ],
          [
            "OG000",
            "71.2"
          ],
          [
            "OG001",
            "14.73"
          ],
          [
            "OG000",
            "50.4"
          ],
          [
            "OG001",
            "3.1"
          ],
          [
            "OG000",
            "61.29"
          ],
          [
            "OG000",
            "47.06"
          ],
          [
            "OG001",
            "17.07"
          ],
          [
            "OG000",
            "5.56"
          ],
          [
            "OG001",
            "35.71"
          ]
        ]
      }
    },
    {
      "gates": {
        "A_aact_exists": true,
        "B_drug_in_intvs": true,
        "C_condition_in_aact": true,
        "D_pmid_topic_match": true,
        "E_two_arms": true,
        "F_primary_outcome_known": true
      },
      "extracted": {
        "nct": "NCT03049735",
        "aact_title": "LIBERTY 1: Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids",
        "aact_acronym": "",
        "start_date": "2017-04-26",
        "primary_completion_date": "2019-04-29",
        "aact_intvs": [
          "relugolix",
          "estradiol/norethindrone acetate",
          "estradiol/norethindrone acetate placebo"
        ],
        "aact_conditions": [
          "heavy menstrual bleeding",
          "uterine fibroid"
        ],
        "pmid": "39466126",
        "pubmed_year": 2024,
        "pubmed_doi": "10.1080/17581869.2024.2408114",
        "aact_per_arm_counts": {
          "BG000": 128,
          "BG001": 132,
          "BG002": 128
        },
        "aact_primary_outcome_measure": "Percentage Of Participants Who Achieved A Menstrual Blood Loss (MBL) Volume Of < 80 mL And A ≥ 50% Reduction From Baseline MBL Volume With Relugolix Plus E2/NETA",
        "aact_outcome_count_rows": [
          [
            "OG000",
            "73.4"
          ],
          [
            "OG001",
            "18.9"
          ],
          [
            "OG000",
            "52.34"
          ],
          [
            "OG001",
            "5.51"
          ],
          [
            "OG000",
            "50.0"
          ],
          [
            "OG001",
            "21.74"
          ],
          [
            "OG000",
            "43.1"
          ],
          [
            "OG001",
            "10.14"
          ],
          [
            "OG000",
            "10.94"
          ],
          [
            "OG001",
            "36.36"
          ]
        ]
      }
    },
    {
      "gates": {
        "A_aact_exists": true,
        "B_drug_in_intvs": true,
        "C_condition_in_aact": true,
        "D_pmid_topic_match": false,
        "E_two_arms": false,
        "F_primary_outcome_known": true
      },
      "extracted": {
        "nct": "NCT06671548",
        "aact_title": "Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids",
        "aact_acronym": "",
        "start_date": "2024-01-15",
        "primary_completion_date": "2026-11-12",
        "aact_intvs": [
          "relugolix",
          "relugolix placebo"
        ],
        "aact_conditions": [
          "heavy menstrual bleeding",
          "uterine fibroids"
        ],
        "pmid": null,
        "aact_per_arm_counts": {},
        "aact_primary_outcome_measure": "Percentage Of Participants Who Achieved A Menstrual Blood Loss (MBL) Volume Of < 80 mL And ≥ 50% Reduction From Baseline MBL Volume",
        "aact_outcome_count_rows": []
      }
    }
  ],
  "n_total": 8,
  "n_pass_all": 6,
  "verdict": "VIABLE",
  "pass_rate": 0.75
}