Last updated: 11/07/2018 15:40:33
An Investigation of the Pharmacokinetics of GI198745 and of the Effects of GI198745 on Semen Characteristics When Administered Daily for 12 Months to Healthy Male Subjects
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: An Investigation of the Pharmacokinetics of GI198745 and of the Effects of GI198745 on Semen Characteristics When Administered Daily for 12 Months to Healthy Male Subjects
Trial description: An Investigation of the Pharmacokinetics of GI198745 and of the Effects of GI198745 on Semen Characteristics When Administered Daily for 12 Months to Healthy Male Subjects
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Abstract: Marked suppression of dihydrotestosterone by dutasteride has no adverse effect on spermatogenesis in healthy men. Clark, R V, Huffman, C S, Haberer, L J, Swerdloff, R S, Wang, C, Matsumoto, A M, and Bremner, W J 84th Annual Meeting of the Endocrine Society 6/19/2002
Clark RV, Huffman CS, Haberer LJ, Swerdloff RS, Wang C, Matsumoto AM, Bremner WJ. Marked suppression of dihydrotestosterone (DHT) by dutasteride has no adverse effect on spermatogenesis in healthy men. SIU 2002.
Clark RV, Huffman CS, Swerdloff RS, Matsumoto AM. Potent DHT suppression by the novel dual 5a-reductase inhibitor Dutasteride does not affect bone density, bone metabolism or lipid profiles in healthy men. EAU 2003
Clark RV. Bone density, bone metabolism and lipid profiles in healthy men are unaffected by the novel dual 5a-reductase inhibitor Dutasteride. AUA 2003
Medical condition
Prostatic Hyperplasia
Product
dutasteride
Collaborators
Not applicable
Study date(s)
July 1998 to October 2000
Type
Not applicable
Phase
1
Participation criteria
Sex
Not applicable
Age
Not applicable
Accepts healthy volunteers
Not applicable
Inclusion and exclusion criteria
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Not applicable
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2000-31-10
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Not applicable
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