|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 February 2015 |
|
Main ID: |
NCT00597051 |
|
Date of registration:
|
08/01/2008 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Study of 3 Doses of ARD-0403 in Testosterone Deficient Men
ARD-0403-001 |
|
Scientific title:
|
A Phase II, Randomized, Double-Blind, Placebo-Controlled, Cross-Over, Multi-Centre Study of the Pharmacokinetics and Tolerability of 3 Different Doses of ARD-0403 in Testosterone Deficient Men |
|
Date of first enrolment:
|
October 2005 |
|
Target sample size:
|
42 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT00597051 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
|
|
Phase:
|
Phase 2
|
|
|
Countries of recruitment
|
|
Belarus
| | | | | | | |
|
Contacts
|
|
Name:
|
Tatiana Mokhort, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Republican Endocrinology Center Hospital, Minsk, Republic of Belarus |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Testosterone deficiency
- Normal BMI
Exclusion Criteria:
- Previous treatment with testosterone replacement therapy within 4 weeks
- Moderate-severe benign prostatic hypertrophy, or prostatic cancer
- Haematocrit >50%
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Male
|
|
Health Condition(s) or Problem(s) studied
|
|
Hypogonadism
|
|
Intervention(s)
|
|
Drug: ARD-0403
|
|
Primary Outcome(s)
|
|
Pharmacokinetic
|
|
Secondary ID(s)
|
|
ARD-0403-001
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|