Skip to main content
main-content

01.12.2017 | Research | Ausgabe 1/2017 Open Access

Reproductive Biology and Endocrinology 1/2017

An open-label clinical trial to investigate the efficacy and safety of corifollitropin alfa combined with hCG in adult men with hypogonadotropic hypogonadism

Zeitschrift:
Reproductive Biology and Endocrinology > Ausgabe 1/2017
Autoren:
Eberhard Nieschlag, Pierre-Marc G. Bouloux, Barbara J. Stegmann, R. Ravi Shankar, Yanfen Guan, Anjela Tzontcheva, Christine McCrary Sisk, Hermann M. Behre
Wichtige Hinweise

Electronic supplementary material

The online version of this article (doi:10.​1186/​s12958-017-0232-y) contains supplementary material, which is available to authorized users.

Abstract

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 μg corifollitropin alfa every other week. The increase in testicular volume (primary efficacy endpoint) and induction of spermatogenesis resulting in a sperm count ≥1 × 106/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 × 106/mL. No subject developed confirmed anti-corifollitropin alfa antibodies during the trial. Treatment was generally well tolerated.

Conclusions

Corifollitropin alfa 150 μg 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.
Zusatzmaterial
Additional file 1: Figure S1. Study design. (EPS 1160 kb)
12958_2017_232_MOESM1_ESM.eps
Additional file 2: Figure S2. Subject disposition. (EPS 1138 kb)
12958_2017_232_MOESM2_ESM.eps
Additional file 3: Table S1. Summary of Adverse Events in the Combined Treatment Phase. (DOCX 29 kb)
12958_2017_232_MOESM3_ESM.docx
Literatur
Über diesen Artikel

Weitere Artikel der Ausgabe 1/2017

Reproductive Biology and Endocrinology 1/2017 Zur Ausgabe

Neu im Fachgebiet Gynäkologie und Geburtshilfe

Meistgelesene Bücher aus dem Fachgebiet

2014 | Buch

Perikonzeptionelle Frauenheilkunde

Fertilitätserhalt, Prävention und Management von Schwangerschaftsrisiken

Ein Praxisbuch für alle, die in der Beratung und Betreuung von Schwangeren und Paaren mit Kinderwunsch tätig sind. Die Herausgeber und Autoren haben alle wichtigen Informationen zusammengetragen, um Frauen sicher zu beraten, zu betreuen und kompetent Verantwortung zu übernehmen.

Herausgeber:
Christian Gnoth, Peter Mallmann

2019 | Buch

Praxisbuch Gynäkologische Onkologie

Dieses kompakte und praxisrelevante Standardwerk richtet sich alle Ärzte in Klinik und Praxis, die Patientinnen mit bösartigen Tumoren des Genitales und der Mamma behandeln. Die 5. Auflage wurde komplett aktualisiert und auf der Basis …

Herausgeber:
Prof. Dr. Edgar Petru, Dr. Daniel Fink, Prof. Dr. Ossi R. Köchli, Prof. Dr. Sibylle Loibl

Mail Icon II Newsletter

Bestellen Sie unseren kostenlosen Newsletter Update Gynäkologie und bleiben Sie gut informiert – ganz bequem per eMail.

Bildnachweise