{
    "info": {
        "nct_id": "NCT00343382",
        "official_title": "Pilocarpine for Vaginal Dryness: A Phase III Randomized, Double Blind, Placebo-Controlled Study",
        "inclusion_criteria": "Healthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "Required Characteristics:\n\n1. Adult post menopausal women or women with no childbearing potential (≥ 18 years) with a history of breast cancer (currently no evidence of disease) or women who do not want to take vaginal estrogen for a fear of an increased risk of breast cancer. Postmenopausal status will be determined by the primary physician.\n2. Significant vaginal complaints defined as persistent vaginal dryness and/or itching of sufficient severity to make a patient desire therapeutic intervention. Symptoms should have been present ≥ 2 months prior to randomization.\n3. Life expectancy > 6 months\n4. Ability to complete questionnaire(s) by themselves or with assistance.\n\nContraindications:\n\n1. Initiation or discontinuation of tamoxifen or aromatase inhibitors ≤2 months prior to randomization or plans to initiate or discontinue any of these medications during the 6-week study.\n2. Active vaginal infection\n3. Concurrent chemotherapy\n4. Acute iritis\n5. Current or past use of pilocarpine (regardless of purpose)\n6. Planned use of any vaginal preparations during the study period (including any over the counter or herbal preparations). Note: Lubricants used during sexual intercourse are permitted.\n7. Use of any vaginal preparations ≤ 1 week prior to study entry (Exception: If patient has used vaginal preparations during the previous week but will stop, then they can be placed on study with plans to start with pretreatment questionnaire one week later). Note: Lubricants used during sexual intercourse are permitted.\n8. Current (≤ 4weeks prior to randomization), or planned during the study period, use of any estrogen product.\n9. A diagnosis of asthma, COPD, CAD or narrow angle glaucoma, or known cholelithiasis.\n10. Hepatic or renal insufficiency defined as a history of an elevation of SGOT ≥1.5 x ULN or creatinine ≥ 1.5 x ULN within the past year.\n11. Concurrent use of other anticholinergics\n12. Use of pharmacologic soy preparations\n13. Known history of cardiac arrhythmia. (Patients with occasional PVC's or PAC's that do not require treatment are eligible.)\n14. Prior or concurrent pelvic radiation therapy\n15. Prior radical pelvic surgery (TAH/BSO is allowed)\n16. Use of beta adrenergic antagonists\n17. Diagnosis of any of the following conditions:\n\n    * Vulvar and vaginal dysplasia\n    * Essential vulvodynia\n    * Vulvar vestibulitis\n    * Vaginal prolapse\n    * Bartholin cyst/abscess\n    * History of Bartholin gland surgery\n    * Lichen sclerosis\n    * Lichen planus of the vulvovaginal region\n    * Desquamative vaginitis"
    },
    "inclusion_lines": [
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must be FEMALE",
            "criterions": [
                {
                    "exact_snippets": "Must be FEMALE",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [
        {
            "line": "1. Adult post menopausal women or women with no childbearing potential (≥ 18 years) with a history of breast cancer (currently no evidence of disease) or women who do not want to take vaginal estrogen for a fear of an increased risk of breast cancer. Postmenopausal status will be determined by the primary physician.",
            "criterions": [
                {
                    "exact_snippets": "Adult post menopausal women",
                    "criterion": "postmenopausal status",
                    "requirements": [
                        {
                            "requirement_type": "determination",
                            "expected_value": "primary physician"
                        }
                    ]
                },
                {
                    "exact_snippets": "women with no childbearing potential",
                    "criterion": "childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "potential",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "≥ 18 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "history of breast cancer",
                    "criterion": "breast cancer history",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "currently no evidence of disease",
                    "criterion": "current breast cancer status",
                    "requirements": [
                        {
                            "requirement_type": "evidence of disease",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "women who do not want to take vaginal estrogen for a fear of an increased risk of breast cancer",
                    "criterion": "vaginal estrogen usage",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Significant vaginal complaints defined as persistent vaginal dryness and/or itching of sufficient severity to make a patient desire therapeutic intervention. Symptoms should have been present ≥ 2 months prior to randomization.",
            "criterions": [
                {
                    "exact_snippets": "Significant vaginal complaints defined as persistent vaginal dryness",
                    "criterion": "vaginal dryness",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "sufficient to make a patient desire therapeutic intervention"
                        },
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Significant vaginal complaints defined as ... itching",
                    "criterion": "vaginal itching",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "sufficient to make a patient desire therapeutic intervention"
                        },
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Life expectancy > 6 months",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy > 6 months",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Ability to complete questionnaire(s) by themselves or with assistance.",
            "criterions": [
                {
                    "exact_snippets": "Ability to complete questionnaire(s) by themselves or with assistance.",
                    "criterion": "ability to complete questionnaire(s)",
                    "requirements": [
                        {
                            "requirement_type": "assistance",
                            "expected_value": [
                                "by themselves",
                                "with assistance"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. Initiation or discontinuation of tamoxifen or aromatase inhibitors ≤2 months prior to randomization or plans to initiate or discontinue any of these medications during the 6-week study.",
            "criterions": [
                {
                    "exact_snippets": "Initiation or discontinuation of tamoxifen ... ≤2 months prior to randomization",
                    "criterion": "tamoxifen initiation or discontinuation",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Initiation or discontinuation of ... aromatase inhibitors ≤2 months prior to randomization",
                    "criterion": "aromatase inhibitors initiation or discontinuation",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "plans to initiate or discontinue any of these medications during the 6-week study",
                    "criterion": "plans to initiate or discontinue tamoxifen or aromatase inhibitors",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "during the 6-week study"
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Active vaginal infection",
            "criterions": [
                {
                    "exact_snippets": "Active vaginal infection",
                    "criterion": "vaginal infection",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "active"
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Concurrent chemotherapy",
            "criterions": [
                {
                    "exact_snippets": "Concurrent chemotherapy",
                    "criterion": "chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "concurrency",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Acute iritis",
            "criterions": [
                {
                    "exact_snippets": "Acute iritis",
                    "criterion": "acute iritis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Current or past use of pilocarpine (regardless of purpose)",
            "criterions": [
                {
                    "exact_snippets": "Current or past use of pilocarpine",
                    "criterion": "pilocarpine use",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Planned use of any vaginal preparations during the study period (including any over the counter or herbal preparations). Note: Lubricants used during sexual intercourse are permitted.",
            "criterions": [
                {
                    "exact_snippets": "Planned use of any vaginal preparations during the study period (including any over the counter or herbal preparations)",
                    "criterion": "vaginal preparations",
                    "requirements": [
                        {
                            "requirement_type": "planned use",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Lubricants used during sexual intercourse are permitted",
                    "criterion": "lubricants used during sexual intercourse",
                    "requirements": [
                        {
                            "requirement_type": "use",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Use of any vaginal preparations ≤ 1 week prior to study entry (Exception: If patient has used vaginal preparations during the previous week but will stop, then they can be placed on study with plans to start with pretreatment questionnaire one week later). Note: Lubricants used during sexual intercourse are permitted.",
            "criterions": [
                {
                    "exact_snippets": "Use of any vaginal preparations ≤ 1 week prior to study entry",
                    "criterion": "use of vaginal preparations",
                    "requirements": [
                        {
                            "requirement_type": "time since last use",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "week"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Lubricants used during sexual intercourse are permitted",
                    "criterion": "use of lubricants during sexual intercourse",
                    "requirements": [
                        {
                            "requirement_type": "permission",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Current (≤ 4weeks prior to randomization), or planned during the study period, use of any estrogen product.",
            "criterions": [
                {
                    "exact_snippets": "Current (≤ 4weeks prior to randomization), or planned during the study period, use of any estrogen product.",
                    "criterion": "use of estrogen product",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": "current or planned during the study period"
                        },
                        {
                            "requirement_type": "timeframe",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 4,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        },
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. A diagnosis of asthma, COPD, CAD or narrow angle glaucoma, or known cholelithiasis.",
            "criterions": [
                {
                    "exact_snippets": "diagnosis of asthma",
                    "criterion": "asthma",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "diagnosis of ... COPD",
                    "criterion": "COPD",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "diagnosis of ... CAD",
                    "criterion": "CAD",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "diagnosis of ... narrow angle glaucoma",
                    "criterion": "narrow angle glaucoma",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "known cholelithiasis",
                    "criterion": "cholelithiasis",
                    "requirements": [
                        {
                            "requirement_type": "known",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Hepatic or renal insufficiency defined as a history of an elevation of SGOT ≥1.5 x ULN or creatinine ≥ 1.5 x ULN within the past year.",
            "criterions": [
                {
                    "exact_snippets": "Hepatic or renal insufficiency defined as a history of an elevation of SGOT ≥1.5 x ULN",
                    "criterion": "SGOT level",
                    "requirements": [
                        {
                            "requirement_type": "history of elevation",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Hepatic or renal insufficiency defined as a history of an elevation of ... creatinine ≥ 1.5 x ULN",
                    "criterion": "creatinine level",
                    "requirements": [
                        {
                            "requirement_type": "history of elevation",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. Concurrent use of other anticholinergics",
            "criterions": [
                {
                    "exact_snippets": "Concurrent use of other anticholinergics",
                    "criterion": "use of other anticholinergics",
                    "requirements": [
                        {
                            "requirement_type": "concurrency",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. Use of pharmacologic soy preparations",
            "criterions": [
                {
                    "exact_snippets": "Use of pharmacologic soy preparations",
                    "criterion": "pharmacologic soy preparations",
                    "requirements": [
                        {
                            "requirement_type": "use",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "13. Known history of cardiac arrhythmia. (Patients with occasional PVC's or PAC's that do not require treatment are eligible.)",
            "criterions": [
                {
                    "exact_snippets": "Known history of cardiac arrhythmia",
                    "criterion": "cardiac arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "occasional PVC's or PAC's that do not require treatment",
                    "criterion": "occasional PVC's or PAC's",
                    "requirements": [
                        {
                            "requirement_type": "treatment requirement",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "14. Prior or concurrent pelvic radiation therapy",
            "criterions": [
                {
                    "exact_snippets": "Prior or concurrent pelvic radiation therapy",
                    "criterion": "pelvic radiation therapy",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": [
                                "prior",
                                "concurrent"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "15. Prior radical pelvic surgery (TAH/BSO is allowed)",
            "criterions": [
                {
                    "exact_snippets": "Prior radical pelvic surgery",
                    "criterion": "prior radical pelvic surgery",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "TAH/BSO is allowed",
                    "criterion": "TAH/BSO",
                    "requirements": [
                        {
                            "requirement_type": "allowance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "16. Use of beta adrenergic antagonists",
            "criterions": [
                {
                    "exact_snippets": "Use of beta adrenergic antagonists",
                    "criterion": "beta adrenergic antagonists",
                    "requirements": [
                        {
                            "requirement_type": "use",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "17. Diagnosis of any of the following conditions:",
            "criterions": [
                {
                    "exact_snippets": "Diagnosis of any of the following conditions",
                    "criterion": "diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Vulvar and vaginal dysplasia",
            "criterions": [
                {
                    "exact_snippets": "Vulvar and vaginal dysplasia",
                    "criterion": "vulvar dysplasia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Vulvar and vaginal dysplasia",
                    "criterion": "vaginal dysplasia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Essential vulvodynia",
            "criterions": [
                {
                    "exact_snippets": "Essential vulvodynia",
                    "criterion": "essential vulvodynia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Vulvar vestibulitis",
            "criterions": [
                {
                    "exact_snippets": "Vulvar vestibulitis",
                    "criterion": "vulvar vestibulitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Vaginal prolapse",
            "criterions": [
                {
                    "exact_snippets": "Vaginal prolapse",
                    "criterion": "vaginal prolapse",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Bartholin cyst/abscess",
            "criterions": [
                {
                    "exact_snippets": "Bartholin cyst/abscess",
                    "criterion": "Bartholin cyst/abscess",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of Bartholin gland surgery",
            "criterions": [
                {
                    "exact_snippets": "History of Bartholin gland surgery",
                    "criterion": "Bartholin gland surgery",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Lichen sclerosis",
            "criterions": [
                {
                    "exact_snippets": "Lichen sclerosis",
                    "criterion": "lichen sclerosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Lichen planus of the vulvovaginal region",
            "criterions": [
                {
                    "exact_snippets": "Lichen planus of the vulvovaginal region",
                    "criterion": "lichen planus",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "vulvovaginal region"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Desquamative vaginitis",
            "criterions": [
                {
                    "exact_snippets": "Desquamative vaginitis",
                    "criterion": "desquamative vaginitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "line": "Required Characteristics:",
            "criterions": []
        },
        {
            "line": "Contraindications:",
            "criterions": []
        }
    ]
}