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| Name | Class |
|---|---|
| Bayer | INDUSTRY |
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Male volunteers receive a new hormonal contraceptive consisting of an implant releasing a hormone and hormone injections in order to investigate the suppressive effect on sperm production and reversibility of sperm production after end of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Active Comparator | etonogestrel with testosterone undecanoate |
|
| Arm 2 | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| etonogestrel with testosterone undecanoate | Drug | 42 or 44 weeks with etonogestrel implant and testosterone undecanoate injections every 10 to 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| % of men who had a sperm concentration of 1 million/ml or less at week 16. | Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Semen Parameters | At several timepoints during treatment | |
| Reversibility of Suppression | Post-Treatment | |
| Hormones |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18413423 | Result | Mommers E, Kersemaekers WM, Elliesen J, Kepers M, Apter D, Behre HM, Beynon J, Bouloux PM, Costantino A, Gerbershagen HP, Gronlund L, Heger-Mahn D, Huhtaniemi I, Koldewijn EL, Lange C, Lindenberg S, Meriggiola MC, Meuleman E, Mulders PF, Nieschlag E, Perheentupa A, Solomon A, Vaisala L, Wu FC, Zitzmann M. Male hormonal contraception: a double-blind, placebo-controlled study. J Clin Endocrinol Metab. 2008 Jul;93(7):2572-80. doi: 10.1210/jc.2008-0265. Epub 2008 Apr 15. |
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| ID | Term |
|---|---|
| C044815 | etonogestrel |
| C010792 | testosterone undecanoate |
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| Placebo | Drug | 42 or 44 weeks with placebo implant and placebo injections |
|
| At several timepoints |
| Pharmacokinetics | At several timepoints |
| Safety | At several timepoints |