Phase 2
N=40
HOP-3 Manipulation of the Intratesticular Hormonal Milieu With Exogenous Testosterone
Healthy Males
Bottom Line
View on ClinicalTrials.gov: NCT00839319 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Nov 2010
Primary outcome: Primary: Serum Testosterone (T) — 0.43; 1.5; 3.7; 8.4 nmol/liter — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Acyline (Drug); placebo hCG (no active ingredient) (Other); hCG (human chorionic gonadotropin) (Drug); Testosterone gel (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Male
- Sponsor
- University of Washington
- Primary completion
- Sep 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Serum Testosterone (T) |
0.43; 1.5; 3.7; 8.4; 16 | <0.05 sig |
| PRIMARY Serum Luteinizing Hormone (LH) |
0.13; 0.28; 0.49; 0.39; 0.14 | — |
| PRIMARY Serum Follicle Stimulating Hormone (FSH) |
0.41; 0.41; 0.29; 0.28; 0.21 | — |
| PRIMARY Intratesticular Testosterone (ITT-T) |
77; 136; 319; 987; 73 | — |
Summary
The purpose of this investigational study is to determine how much male hormone, testosterone, is necessary to maintain sperm production in the testis. This knowledge will be used to help in the development of a safe male hormonal contraception.
Eligibility Criteria
Inclusion Criteria
- Males age 18-50
- Normal serum testosterone, LH and FSH
- PSA 32
- Subjects with a skin condition that might interfere or be exacerbated by testosterone gel use
- Subject's with alcohol or drug use
Data sourced from ClinicalTrials.gov (NCT00839319). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.