Biological actions of estradiol in men trial

Phase 2

• Conditions: Bone loss; Prostate Cancer; Hypogonadism; Musculoskeletal - Osteoporosis; Cancer - Prostate; Metabolic and Endocrine - Other endocrine disorders

• Registration Number: ACTRN12614000689673
• Lead Sponsor: niversity of Melbourne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-06-30
• Study Completion: 2020-08-24
• Last Update Posted: 21 June 2021

Recruitment & Eligibility

• Status: Stopped early
• Sex: Male
• Target Recruitment: 78

Inclusion Criteria

1. Men with prostate cancer receiving gonadotropin-releasing hormone agonists or antagonists to suppress androgen production
2. Androgen Deprivation Therapy intended to continue for at least 6 months
3. Able and willing to comply with the study protocol requirements

Exclusion Criteria

1. Bone metastases within imaging fields detectable by conventional imaging (e.g. CT scanning, bone scanning)
2. Significantly impaired performance status (ECOG > 2)
3. Previous history of deep vein thrombosis or pulmonary embolism
4. Stroke, transient ischaemic attack, myocardial infarction, or angina within the previous 12 months
5. New York Heart Association class 3-4 heart failure
6. Systolic blood pressure of 160 mmHg or higher or diastolic blood pressure of 100 mmHg or higher, or both.
7. Previous history of breast cancer
8. Current oral glucocorticoid therapy
9. Any current or previous antiresorptive therapy
10. Recreational drug use, alcohol dependence, known HIV/AIDS or any disease which is likely to lead to serious illness or death within the study period
11. Inability to understand sufficient English to give informed consent.

Study & Design

• Study Type: Interventional
• Study Design: Not specified