Linked Life Data

11836281

Source:http://linkedlifedata.com/resource/pubmed/id/11836281

Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
2
pubmed:dateCreated
2002-2-11
pubmed:abstractText
Suppression of spermatogenesis to azoospermia is the goal of hormonal male contraception based on T combined with gestagens. The combination of the long-acting T, ester testosterone undecanoate (TU), with norethisterone (NET) enanthate (E) showed high efficacy. In the present study, we tested the validity of this approach by varying the NET dose and mode of application. The aim of the study was to achieve high rates of suppression of spermatogenesis as reflected by sperm counts, monitor gonadotropins as well as other hormones, and evaluate any possible side effects. In a phase II clinical trial, groups of normal volunteers received: 1000 mg TU im at wk 2, 6, 12, and 18 combined with 200 mg NETE im at wk 0, 6, 12, and 18 (group I); 1000 mg TU im and 400 mg NETE im at wk 0, 6, 12, and 18 (group II); and 1000 mg TU im at wk 0, 6, 12, and 18 with daily oral NET acetate (NETA) from wk 0 to 24 (group III). In all groups marked suppression of gonadotropins resulted in a significant decrease of spermatogenesis and azoospermia in 13/14, 11/12, and 12/14 men in groups I to III, respectively. The remaining men all had less than 1 million sperm/ml. Reversible side effects included increase in body weight, erythrocytes, hemoglobin, and hematocrit and decrease in high-density lipoprotein cholesterol and alkaline phosphatase in all groups and increase in liver enzymes in the oral NETA group. This study documents the high efficacy of TU in combination with NET and confirms that this dose and mode of application (1000 mg TU im every 6 wk plus 400 mg NETE im every 6 wk or plus 10 mg daily oral NETA) is as effective as the previously reported regimen containing 1000 mg TU + 200 mg NETE im every 6 wk. The contraceptive efficacy of this combination of TU and NETE should be evaluated in further clinical trials.
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
AIM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:month
Feb
pubmed:issn
0021-972X
pubmed:author
pubmed:issnType
Print
pubmed:volume
87
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
530-9
pubmed:dateRevised
2006-11-15
pubmed:meshHeading
pubmed-meshheading:11836281-Administration, Oral, pubmed-meshheading:11836281-Adult, pubmed-meshheading:11836281-Blood, pubmed-meshheading:11836281-Coitus, pubmed-meshheading:11836281-Contraceptive Agents, Male, pubmed-meshheading:11836281-Contraceptives, Oral, Synthetic, pubmed-meshheading:11836281-Drug Synergism, pubmed-meshheading:11836281-Hormones, pubmed-meshheading:11836281-Humans, pubmed-meshheading:11836281-Injections, Intramuscular, pubmed-meshheading:11836281-Lipids, pubmed-meshheading:11836281-Male, pubmed-meshheading:11836281-Middle Aged, pubmed-meshheading:11836281-Norethindrone, pubmed-meshheading:11836281-Prostate, pubmed-meshheading:11836281-Sperm Count, pubmed-meshheading:11836281-Spermatogenesis, pubmed-meshheading:11836281-Testis, pubmed-meshheading:11836281-Testosterone, pubmed-meshheading:11836281-Testosterone Congeners
pubmed:year
2002
pubmed:articleTitle
An effective hormonal male contraceptive using testosterone undecanoate with oral or injectable norethisterone preparations.
pubmed:affiliation
Institute of Reproductive Medicine of the University, D-48129 Münster, Germany.
pubmed:publicationType
Journal Article, Clinical Trial, Randomized Controlled Trial, Research Support, Non-U.S. Gov't, Clinical Trial, Phase II