Status:
WITHDRAWN
Influence of Administration Route of Testosterone on Male Fertility
Lead Sponsor:
Acerus Pharmaceuticals Corporation
Conditions:
Hypogonadism
Eligibility:
MALE
50-80 years
Phase:
PHASE1
Brief Summary
Exogenously administered testosterone will override the normal negative feedback of endogenous testosterone on the hypothalamus and pituitary. Constantly, relatively high and constant testosterone lev...
Eligibility Criteria
Inclusion
- Age greater than or equal to 50 years but not older than 80 years of age;
- Serum testosterone level \<13.8 nmol/l;
- Sperm concentration \> 40 Million/ml;
- Willing to give written informed consent.
Exclusion
- Testicular diseases or having had any surgical procedures applied to the testes;
- History or currently existing serious disease of any type, in particular liver, kidney or heart disease, any form of diabetes mellitus, cancer or psychiatric illness;
- Current androgen, anabolic steroid or sex hormone treatment or any treatment with such compounds in the previous 6 months;
- Blood donation within the 12-week period before the initial study dose.
- History of, or current nasal disorders (e.g. seasonal or perennial allergic rhinitis, atrophic rhinitis, polyposis, abuse of nasal decongestants, clinically relevant nasal septum deviation, recurrent epistaxis) or sleep apnea;
- Elevated serum PSA levels (\> 4 ng/ml for subjects \>= 50 years of age);
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00705796
Last Update
March 13 2018
Active Locations (1)
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1
AMPHA
Nijmegen, Netherlands, 6525 EC