PMID- 28270212
OWN - NLM
STAT- MEDLINE
DCOM- 20170707
LR  - 20181113
IS  - 1477-7827 (Electronic)
IS  - 1477-7827 (Linking)
VI  - 15
IP  - 1
DP  - 2017 Mar 7
TI  - An open-label clinical trial to investigate the efficacy and safety of 
      corifollitropin alfa combined with hCG in adult men with hypogonadotropic 
      hypogonadism.
PG  - 17
LID - 10.1186/s12958-017-0232-y [doi]
LID - 17
AB  - BACKGROUND: Hypogonadotropic hypogonadism (HH) in men results in insufficient 
      testicular function and deficiencies in testosterone and spermatogenesis. 
      Combinations of human chorionic gonadotropin (hCG) and recombinant 
      follicle-stimulating hormone (recFSH) have been successful in the treatment of 
      HH. Corifollitropin alfa is a long-acting FSH-analog with demonstrated action in 
      women seeking infertility care. The aim of this study was to investigate the 
      efficacy and safety of corifollitropin alfa combined with hCG to increase 
      testicular volume and induce spermatogenesis in men with HH. METHODS: This was a 
      Phase III, multi-center, open-label, single-arm trial of corifollitropin alfa in 
      azoospermic men aged 18 to 50 years with HH. After 16 weeks of pretreatment of 23 
      subjects with hCG alone, 18 subjects with normalized testosterone (T) levels who 
      remained azoospermic entered the 52-week combined treatment phase with hCG 
      twice-weekly and 150 mug corifollitropin alfa every other week. The increase in 
      testicular volume (primary efficacy endpoint) and induction of spermatogenesis 
      resulting in a sperm count >/=1 x 10(6)/mL (key secondary efficacy endpoint) during 
      52 weeks of combined treatment were assessed. Safety was evaluated by the 
      presence of anti-corifollitropin alfa antibodies and the occurrence of adverse 
      events (AEs). RESULTS: Mean (+/-SD) testicular volume increased from 8.6 (+/-6.09) mL 
      to 17.8 (+/-8.93) mL (geometric mean fold increase, 2.30 [95% CI: 2.03, 2.62]); 14 
      (77.8%) subjects reached a sperm count >/=1 x 10(6)/mL. No subject developed 
      confirmed anti-corifollitropin alfa antibodies during the trial. Treatment was 
      generally well tolerated. CONCLUSIONS: Corifollitropin alfa 150 mug administrated 
      every other week combined with twice-weekly hCG for 52 weeks increased testicular 
      volume significantly, and induced spermatogenesis in >75% of men with HH who had 
      remained azoospermic after hCG treatment alone. TRIAL REGISTRATION: 
      ClinicalTrials.gov: NCT01709331 .
FAU - Nieschlag, Eberhard
AU  - Nieschlag E
AUID- ORCID: 0000-0002-1403-3298
AD  - University Hospital of Muenster, Center of Reproductive Medicine and Andrology, 
      Domagkstrasse 11, D-48149, Muenster, Germany. eberhard.nieschlag@ukmuenster.de.
FAU - Bouloux, Pierre-Marc G
AU  - Bouloux PG
AD  - The Royal Free Hospital, Pond St, London, NW3 2QG, UK.
FAU - Stegmann, Barbara J
AU  - Stegmann BJ
AD  - Merck & Co., Inc., 2000 Galloping Hill Road, Kenilworth, NJ, 07033, USA.
FAU - Shankar, R Ravi
AU  - Shankar RR
AD  - Merck & Co., Inc., 2000 Galloping Hill Road, Kenilworth, NJ, 07033, USA.
FAU - Guan, Yanfen
AU  - Guan Y
AD  - Merck & Co., Inc., 2000 Galloping Hill Road, Kenilworth, NJ, 07033, USA.
FAU - Tzontcheva, Anjela
AU  - Tzontcheva A
AD  - Merck & Co., Inc., 2000 Galloping Hill Road, Kenilworth, NJ, 07033, USA.
FAU - McCrary Sisk, Christine
AU  - McCrary Sisk C
AD  - Merck & Co., Inc., 2000 Galloping Hill Road, Kenilworth, NJ, 07033, USA.
FAU - Behre, Hermann M
AU  - Behre HM
AD  - University Hospital Halle (Saale), Martin Luther University Halle-Wittenberg, 
      Ernst-Grube-Str. 40, D-06120, Halle, Germany.
LA  - eng
SI  - ClinicalTrials.gov/NCT01709331
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
DEP - 20170307
PL  - England
TA  - Reprod Biol Endocrinol
JT  - Reproductive biology and endocrinology : RB&E
JID - 101153627
RN  - 0 (Chorionic Gonadotropin)
RN  - 0 (Follicle Stimulating Hormone, Human)
RN  - 0 (follicle stimulating hormone, human, with HCG C-terminal peptide)
SB  - IM
MH  - Adult
MH  - Azoospermia/complications/*drug therapy
MH  - Chorionic Gonadotropin/*therapeutic use
MH  - Drug Administration Schedule
MH  - Follicle Stimulating Hormone, Human/*therapeutic use
MH  - Humans
MH  - Hypogonadism/complications/*drug therapy
MH  - Male
MH  - Middle Aged
MH  - Organ Size/drug effects
MH  - Spermatogenesis/drug effects
MH  - Testis/drug effects/pathology
MH  - Treatment Outcome
MH  - Young Adult
PMC - PMC5341390
OTO - NOTNLM
OT  - Corifollitropin alfa
OT  - Gonadotropin deficiency
OT  - Hypogonadotropic hypogonadism
OT  - Male infertility
OT  - Testis
EDAT- 2017/03/09 06:00
MHDA- 2017/07/08 06:00
PMCR- 2017/03/07
CRDT- 2017/03/09 06:00
PHST- 2017/01/18 00:00 [received]
PHST- 2017/02/21 00:00 [accepted]
PHST- 2017/03/09 06:00 [entrez]
PHST- 2017/03/09 06:00 [pubmed]
PHST- 2017/07/08 06:00 [medline]
PHST- 2017/03/07 00:00 [pmc-release]
AID - 10.1186/s12958-017-0232-y [pii]
AID - 232 [pii]
AID - 10.1186/s12958-017-0232-y [doi]
PST - epublish
SO  - Reprod Biol Endocrinol. 2017 Mar 7;15(1):17. doi: 10.1186/s12958-017-0232-y.