Sample 20: NCT02730169

Model: local-gemma2-2b · RAG: no_rag · View on ClinicalTrials.gov

Ground Truth

Inclusion Criteria:Adult male subject aged 18 to 65 years inclusiveBMI > 30 kg/m2 and < 50 kg/m2Serum total testosterone concentration below the normal rangeLH levels below the upper limit of normalOestradiol levels within or above the normal range of approved assayAt least two symptoms of androgen deficiency present for at least 2 months prior to the first Screening Visit, with at least one of these being a sexual dysfunctionExclusion Criteria:Evidence of clinically significant endocrinopathy at screening that may interfere with the study assessmentsOther types of hypogonadotropic hypogonadism or primary hypogonadismAny other pituitary or hypothalamic disease

InclusionINCLUSION Criteria:AdultCRITERIA

  1. Adult male subject aged 18 to 65 years inclusiveBMI &gt;> 30 kg&#x2F;m2kg/m2 and &lt;< 50 kg&#x2F;m2Serumkg/m2
  2. Serum total testosterone concentration below the normal rangeLH levels below the upper limit of normalOestradiolnormal
  3. Oestradiol levels within or above the normal range of approved assayAt least two symptoms of androgen deficiency present for at least 2 months prior to the first Screening Visit, with at least one of these being a sexual dysfunctionExclusiondysfunction

EXCLUSION Criteria:EvidenceCRITERIA

  1. Evidence of clinically significant endocrinopathy at screening that may interfere with the study assessmentsOtherassessments
  2. Other types of hypogonadotropic hypogonadism or primary hypogonadismAnyhypogonadism
  3. Any other pituitary or hypothalamic disease

Prediction

##  Modified Eligibility Criteria for Clinical Trial Version 10

**Inclusion Criteria:**

* **Age:** Adult male, aged 18 to 65 years inclusive.
* **BMI:**  BMI > 30 kg/m2 
* **HbA1c:** HbA1c ≤ 10.5% at Screening.
* **Type 2 Diabetes:**  
    * HbA1c ≤ 10.5% at Screening.
    * Anti-diabetic medication regimen (excluding insulin) has been stable for ≥ 8 weeks before the first Screening visit.
* **Other Exclusion Criteria:**
    *  History of monoclonal antibodies, insulin, or other medications known to affect sex hormone production within the 4 weeks prior to the first Screening Visit.
    *  Weight loss or weight gain (gain or loss > 5% body weight) OR weight reduction surgery or procedure within the 3 months prior to first Screening Visit.
    *  Participation in any clinical trial using clinical investigational product intervention within 3 months before first Screening Visit or 5 half-lives of investigational product administration, whichever is longer.
    *  Medical history of Long QT syndrome.
    *  History of thromboembolic disease.
    *  Grade ≥3 lower extremity oedema.
    *  Use of cardiac pacemaker or other medical electronic devices that can be affected by bioimpedance assessment.
    *  Medical diagnosis of any of the following cardiovascular conditions within the 6 months prior to first Screening Visit:
        * Myocardial infarction or unstable angina.
        * Coronary artery bypass surgery, balloon angioplasty, percutaneous coronary intervention or carotid revascularisation procedure.
        * Uncontrolled hypertension within the 3 months prior to first Screening Visit.
        * Significant cardiac arrhythmia (as determined by the investigator).
        * Endovascular procedure or surgical intervention for peripheral vascular disease within the 3 months prior to first Screening Visit.
        * Advanced ischemic heart disease.

**Note:**  The specific inclusion and exclusion criteria may vary depending on the version of the protocol.

##  Modified Eligibility Criteria for Clinical Trial Version 10

**InclusionINCLUSION Criteria:**

*CRITERIA

  1. **Age:**Age: Adult male, aged 18 to 65 years inclusive.
*
  2. **BMI:**  BMI: BMI > 30 kg/m2 
*
  3. **HbA1c:**HbA1c: HbA1c ≤ 10.5% at Screening.
*
  4. **TypeType 2 Diabetes:**  
    *Diabetes:
  5. HbA1c ≤ 10.5% at Screening.
    *
  6. Anti-diabetic medication regimen (excluding insulin) has been stable for ≥ 8 weeks before the first Screening visit.
*
  7. **OtherOther

EXCLUSION ExclusionCRITERIA

  1. Criteria:**
    *  History of monoclonal antibodies, insulin, or other medications known to affect sex hormone production within the 4 weeks prior to the first Screening Visit.
    *  
  2. Weight loss or weight gain (gain or loss > 5% body weight) OR weight reduction surgery or procedure within the 3 months prior to first Screening Visit.
    *  
  3. Participation in any clinical trial using clinical investigational product intervention within 3 months before first Screening Visit or 5 half-lives of investigational product administration, whichever is longer.
    *  
  4. Medical history of Long QT syndrome.
    *  
  5. History of thromboembolic disease.
    *  
  6. Grade ≥3 lower extremity oedema.
    *  
  7. Use of cardiac pacemaker or other medical electronic devices that can be affected by bioimpedance assessment.
    *  
  8. Medical diagnosis of any of the following cardiovascular conditions within the 6 months prior to first Screening Visit:
        *
  9. Myocardial infarction or unstable angina.
        *
  10. Coronary artery bypass surgery, balloon angioplasty, percutaneous coronary intervention or carotid revascularisation procedure.
        *
  11. Uncontrolled hypertension within the 3 months prior to first Screening Visit.
        *
  12. Significant cardiac arrhythmia (as determined by the investigator).
        *
  13. Endovascular procedure or surgical intervention for peripheral vascular disease within the 3 months prior to first Screening Visit.
        *
  14. Advanced ischemic heart disease.

**Note:**  
  15. Note:** The specific inclusion and

EXCLUSION exclusion criteriaCRITERIA

  1. may vary depending on the version of the protocol.