Topical estradiol add-back in hypogonadal men: dose-finding study

Phase 1

Completed

• Conditions: Prostate Cancer; Hypogonadism; Cancer - Prostate; Metabolic and Endocrine - Other endocrine disorders

• Registration Number: ACTRN12616000373471
• Lead Sponsor: niversity of Melbourne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-03-23
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 36

Inclusion Criteria

1) Men with Prostate Cancer without metastases to bone or viscera detectable on staging with computed tomography or bone scanning.
2) Receiving treatment with GnRH agonists to suppress androgen production with a planned duration of further treatment of greater than 4 weeks

Exclusion Criteria

1) Impaired performance status (ECOG >1)
2) History of deep vein thrombosis or pulmonary embolism
3) Stroke, transient ischaemic attack, myocardial infarction, or angina within last 12 months
4) Systolic BP > 160 or DBP > 100
5) Symptomatic heart failure (NYHA class > 1)
6) History of breast cancer
7) Pre-existing osteoporosis
8) Prior treatment with glucocorticoids or bisphosphonates
9) Diabetes Mellitus
10) Alcohol dependence or recreational drug use

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Serum estradiol level[Weekly from baseline to end of 4 week intervention period.]