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A Study of the Efficacy and Safety of Corifollitropin Alfa (MK-8962) in Combination With Human Chorionic Gonadotropin (hCG) in Adult Men With Hypogonadotropic Hypogonadism (HH) (P07937)

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ClinicalTrials.gov Identifier: NCT01709331
Recruitment Status : Completed
First Posted : October 18, 2012
Results First Posted : May 9, 2016
Last Update Posted : September 3, 2018
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Hypogonadism
Hypogonadotropic Hypogonadism
Interventions Drug: Corifollitropin alfa
Drug: hCG
Enrollment 18
Recruitment Details  
Pre-assignment Details Twenty-three participants entered the 16-week pretreatment phase with hCG. At the end of the pretreatment phase, 18 participants were enrolled in the 52-week combined treatment phase.
Arm/Group Title Corifollitropin Alfa 150 μg + hCG
Hide Arm/Group Description During a 16-week pretreatment phase, participants received twice-weekly subcutaneous (SC) injections of human chorionic gonadotropin (hCG) 1500 or 3000 IU. Eligible participants were then enrolled in the combined treatment phase in which they received a single dose of corifollitropin alfa 150 μg by SC injection once every 2 weeks for 52 weeks. In addition, eligible participants continued to receive twice-weekly hCG injections on the same schedule begun during the pretreatment phase.
Period Title: Overall Study
Started 18
Completed 17
Not Completed 1
Reason Not Completed
Adverse Event             1
Arm/Group Title Corifollitropin Alfa 150 μg + hCG
Hide Arm/Group Description During a 16-week pretreatment phase, participants received twice-weekly SC injections of hCG 1500 or 3000 IU. Eligible participants were then enrolled in the combined treatment phase in which they received a single dose of corifollitropin alfa 150 μg by SC injection once every 2 weeks for 52 weeks. In addition, eligible participants continued to receive twice-weekly hCG injections on the same schedule begun during the pretreatment phase.
Overall Number of Baseline Participants 18
Hide Baseline Analysis Population Description
All participants enrolled in the combined treatment phase
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants
31.5  (8.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
Female
0
   0.0%
Male
18
 100.0%
1.Primary Outcome
Title Change From Baseline in Log-Transformed Testicular Volume at Week 52
Hide Description Participants underwent testicular ultrasound in the pretreatment phase at Weeks -16, -8, -1; and during the combined treatment phase at Baseline (predose, Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52. The testicular volume was measured as the sum of volumes of left and right testes. The mean change from Day 1 in log-transformed testicular volume was analyzed using a mixed model with a fixed effect for time point and a random effect for the participant. For each time point, the mean change from Day 1 to that time point and the associated 95% confidence interval (CI) was calculated. The geometric mean fold change in testicular volume and its 95% CI was obtained by exponentiation.
Time Frame Baseline and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) population, which consisted of all participants who received any dose of corifollitropin alfa and who had a baseline and at least one post-baseline measurement of testicular volume.
Arm/Group Title Corifollitropin Alfa 150 μg + hCG
Hide Arm/Group Description:
During a 16-week pretreatment phase, participants received twice-weekly SC injections of hCG 1500 or 3000 IU. Eligible participants were then enrolled in the combined treatment phase in which they received a single dose of corifollitropin alfa 150 μg by SC injection once every 2 weeks for 52 weeks. In addition, eligible participants continued to receive twice-weekly hCG injections on the same schedule begun during the pretreatment phase.
Overall Number of Participants Analyzed 18
Geometric Mean (95% Confidence Interval)
Unit of Measure: Fold change
2.3
(2.03 to 2.62)
2.Primary Outcome
Title Percentage of Participants With Anti-Corifollitropin Alfa Antibodies
Hide Description Blood samples were collected for assessment of anti-corifollitropin alfa antibodies in the pretreatment phase at Week -16 and Week -1; during the combined treatment phase at Weeks 4, 16, 28, 50, 52; and at the post-treatment follow-up visit, which could occur from Week 53 up to Week 57.
Time Frame Up to Week 57
Hide Outcome Measure Data
Hide Analysis Population Description
All-Subjects-as-Treated (ASaT) population, which consisted of all participants who received any dose of corifollitropin alfa.
Arm/Group Title Corifollitropin Alfa 150 μg + hCG
Hide Arm/Group Description:
During a 16-week pretreatment phase, participants received twice-weekly SC injections of hCG 1500 or 3000 IU. Eligible participants were then enrolled in the combined treatment phase in which they received a single dose of corifollitropin alfa 150 μg by SC injection once every 2 weeks for 52 weeks. In addition, eligible participants continued to receive twice-weekly hCG injections on the same schedule begun during the pretreatment phase.
Overall Number of Participants Analyzed 18
Measure Type: Number
Unit of Measure: Percentage of participants
0
3.Secondary Outcome
Title Percentage of Participants With Induced Spermatogenesis Resulting in a Sperm Count ≥1x10^6/mL at or Before Week 52
Hide Description Semen samples were produced by masturbation after at least 48 hours of sexual abstinence and collected for evaluation in the pretreatment phase at Week -1, and during the combined treatment phase at Weeks 16, 28, 40, and 52.
Time Frame Up to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population, which consisted of all participants who received any dose of corifollitropin alfa and who had a baseline and at least one post-baseline measurement of testicular volume.
Arm/Group Title Corifollitropin Alfa 150 μg + hCG
Hide Arm/Group Description:
During a 16-week pretreatment phase, participants received twice-weekly SC injections of hCG 1500 or 3000 IU. Eligible participants were then enrolled in the combined treatment phase in which they received a single dose of corifollitropin alfa 150 μg by SC injection once every 2 weeks for 52 weeks. In addition, eligible participants continued to receive twice-weekly hCG injections on the same schedule begun during the pretreatment phase.
Overall Number of Participants Analyzed 18
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
77.8
(52.4 to 93.6)
Time Frame Up to Week 57
Adverse Event Reporting Description The Safety Analysis was based on the ASaT population, which consisted of all participants who received any dose of corifollitropin alfa.
 
Arm/Group Title Corifollitropin Alfa 150 μg + hCG
Hide Arm/Group Description During a 16-week pretreatment phase, participants received twice-weekly SC injections of hCG 1500 or 3000 IU. Eligible participants were then enrolled in the combined treatment phase in which they received a single dose of corifollitropin alfa 150 μg by SC injection once every 2 weeks for 52 weeks. In addition, eligible participants continued to receive twice-weekly hCG injections on the same schedule begun during the pretreatment phase.
All-Cause Mortality
Corifollitropin Alfa 150 μg + hCG
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Corifollitropin Alfa 150 μg + hCG
Affected / at Risk (%) # Events
Total   0/18 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Corifollitropin Alfa 150 μg + hCG
Affected / at Risk (%) # Events
Total   11/18 (61.11%)    
Gastrointestinal disorders   
Abdominal pain  1  1/18 (5.56%)  1
Diarrhoea  1  1/18 (5.56%)  1
Haemorrhoids  1  1/18 (5.56%)  1
Immune system disorders   
Seasonal allergy  1  1/18 (5.56%)  1
Infections and infestations   
Conjunctivitis  1  1/18 (5.56%)  1
Nasopharyngitis  1  4/18 (22.22%)  5
Investigations   
Blood pressure increased  1  1/18 (5.56%)  1
Blood testosterone increased  1  2/18 (11.11%)  2
Oestradiol increased  1  3/18 (16.67%)  4
Testicular scan abnormal  1  1/18 (5.56%)  1
Blood testosterone decreased  1  2/18 (11.11%)  2
Musculoskeletal and connective tissue disorders   
Musculoskeletal pain  1  1/18 (5.56%)  1
Nervous system disorders   
Headache  1  3/18 (16.67%)  4
Reproductive system and breast disorders   
Breast tenderness  1  1/18 (5.56%)  1
Skin and subcutaneous tissue disorders   
Acne  1  1/18 (5.56%)  1
Alopecia  1  1/18 (5.56%)  1
Hyperhidrosis  1  1/18 (5.56%)  1
Vascular disorders   
Flushing  1  1/18 (5.56%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The investigator further agrees to provide to the sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication (including, without limitation, slides and texts of oral or other public presentations and texts of any transmission through any electronic media, e.g., any computer access system such as the Internet, World Wide Web, etc) that report any results of the trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
EMail: ClinicalTrialsDisclosure@merck.com
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01709331     History of Changes
Other Study ID Numbers: P07937
2012-001258-25 ( EudraCT Number )
MK-8962-031 ( Other Identifier: Merck )
First Submitted: October 16, 2012
First Posted: October 18, 2012
Results First Submitted: April 4, 2016
Results First Posted: May 9, 2016
Last Update Posted: September 3, 2018