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document
A placebo-controlled , randomized clinical trial using testosterone undecanoate with injectable norethisterone enanthate : effect on anthropometric , metabolic and biochemical parameters . Testosterone administered alone or in combination with progestogens in male contraception induces reversible oligo-azoospermia , but its effects on body composition and metabolism are less known . We analysed anthropometric and metabolic parameters in five groups of 10 males : four receiving testosterone undecanoate ( TU : 1000 mg ) plus norethisterone enanthate ( NETE : 200 mg ) at different intervals ( every 8 weeks : NETE-8 ; every 12 weeks : NETE-12 ; every 6 weeks for 12 weeks and then every 12 weeks : NETE-6/12 ; every 6 weeks for 12 weeks and then TU plus placebo every 12 weeks : NETE-6/12/0 ) and one placebo ( NETE-0/0 ) for a total of 48 weeks . Body mass index ( BMI ) and waist circumference did not change in any groups except for the NETE-8 in which BMI increased significantly ( p = 0.02 ) at the end of the treatment period . Lean body mass ( MAMC or AMA ) increased significantly in the highest hormonal dose groups ( p = 0.04 , NETE-6/12 ; p = 0.004 , NETE-8 ) . No differences were observed in glucose levels , insulin sensitivity index and lipid profile as well as in biochemical and cell count parameters in any groups . In conclusion , NETE and TU for 48 weeks were not accompanied by any metabolic changes and any adverse effects . The weight gain of the highest NETE plus TU dosage was mainly because of gain in muscle mass .
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Intervention_Control
placebo-controlled
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Intervention_Pharmacological
testosterone undecanoate with injectable norethisterone enanthate :
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Intervention_Pharmacological
testosterone undecanoate
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Intervention_Pharmacological
plus norethisterone enanthate
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Intervention_Pharmacological
TU plus placebo
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Intervention_Control
placebo
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Outcome_Physical
Body mass index ( BMI ) and waist circumference did not change
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Outcome_Physical
BMI increased significantly
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Outcome_Physical
Lean body mass ( MAMC or AMA ) increased significantly
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Outcome_Physical
glucose levels , insulin sensitivity index and lipid profile
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Outcome_Physical
biochemical and cell count parameters
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Outcome_Physical
metabolic changes and any
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Outcome_Adverse-effects
adverse effects
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Outcome_Physical
weight gain
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Participant_Condition
anthropometric , metabolic and biochemical parameters .