Trial Outcomes & Findings for 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) (NCT NCT01709331)

Last Updated: 2024-05-24

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

18 participants

Primary outcome timeframe

Baseline and Week 52

Results posted on

2024-05-24

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Corifollitropin Alfa 150 μg + hCG 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.
Overall Study STARTED	18
Overall Study COMPLETED	17
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Corifollitropin Alfa 150 μg + hCG 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.
Overall Study Adverse Event	1

Baseline Characteristics

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)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Corifollitropin Alfa 150 μg + hCG n=18 Participants 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.
Age, Continuous	31.5 Years STANDARD_DEVIATION 8.8 • n=93 Participants
Sex: Female, Male Female	0 Participants n=93 Participants
Sex: Female, Male Male	18 Participants n=93 Participants

PRIMARY outcome

Timeframe: Baseline and Week 52

Population: 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.

Outcome measures

Outcome measures
Measure	Corifollitropin Alfa 150 μg + hCG n=18 Participants 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.
Change From Baseline in Log-Transformed Testicular Volume at Week 52	2.3 Fold change Interval 2.03 to 2.62

PRIMARY outcome

Timeframe: Up to Week 57

Population: All-Subjects-as-Treated (ASaT) population, which consisted of all participants who received any dose of corifollitropin alfa.

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.

Outcome measures

Outcome measures
Measure	Corifollitropin Alfa 150 μg + hCG n=18 Participants 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.
Percentage of Participants With Anti-Corifollitropin Alfa Antibodies	0 Percentage of participants Interval 52.4 to 93.6

SECONDARY outcome

Timeframe: Up to Week 52

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Corifollitropin Alfa 150 μg + hCG n=18 Participants 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.
Percentage of Participants With Induced Spermatogenesis Resulting in a Sperm Count ≥1x10^6/mL at or Before Week 52	77.8 Percentage of participants Interval 52.4 to 93.6

Adverse Events

Corifollitropin Alfa 150 μg + hCG

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Corifollitropin Alfa 150 μg + hCG n=18 participants at risk 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.
Gastrointestinal disorders Abdominal pain	5.6% 1/18 • Number of events 1 • Up to Week 57 The Safety Analysis was based on the ASaT population, which consisted of all participants who received any dose of corifollitropin alfa.
Gastrointestinal disorders Diarrhoea	5.6% 1/18 • Number of events 1 • Up to Week 57 The Safety Analysis was based on the ASaT population, which consisted of all participants who received any dose of corifollitropin alfa.
Gastrointestinal disorders Haemorrhoids	5.6% 1/18 • Number of events 1 • Up to Week 57 The Safety Analysis was based on the ASaT population, which consisted of all participants who received any dose of corifollitropin alfa.
Immune system disorders Seasonal allergy	5.6% 1/18 • Number of events 1 • Up to Week 57 The Safety Analysis was based on the ASaT population, which consisted of all participants who received any dose of corifollitropin alfa.
Infections and infestations Conjunctivitis	5.6% 1/18 • Number of events 1 • Up to Week 57 The Safety Analysis was based on the ASaT population, which consisted of all participants who received any dose of corifollitropin alfa.
Infections and infestations Nasopharyngitis	22.2% 4/18 • Number of events 5 • Up to Week 57 The Safety Analysis was based on the ASaT population, which consisted of all participants who received any dose of corifollitropin alfa.
Investigations Blood pressure increased	5.6% 1/18 • Number of events 1 • Up to Week 57 The Safety Analysis was based on the ASaT population, which consisted of all participants who received any dose of corifollitropin alfa.
Investigations Blood testosterone increased	11.1% 2/18 • Number of events 2 • Up to Week 57 The Safety Analysis was based on the ASaT population, which consisted of all participants who received any dose of corifollitropin alfa.
Investigations Oestradiol increased	16.7% 3/18 • Number of events 4 • Up to Week 57 The Safety Analysis was based on the ASaT population, which consisted of all participants who received any dose of corifollitropin alfa.
Investigations Testicular scan abnormal	5.6% 1/18 • Number of events 1 • Up to Week 57 The Safety Analysis was based on the ASaT population, which consisted of all participants who received any dose of corifollitropin alfa.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	5.6% 1/18 • Number of events 1 • Up to Week 57 The Safety Analysis was based on the ASaT population, which consisted of all participants who received any dose of corifollitropin alfa.
Nervous system disorders Headache	16.7% 3/18 • Number of events 4 • Up to Week 57 The Safety Analysis was based on the ASaT population, which consisted of all participants who received any dose of corifollitropin alfa.
Reproductive system and breast disorders Breast tenderness	5.6% 1/18 • Number of events 1 • Up to Week 57 The Safety Analysis was based on the ASaT population, which consisted of all participants who received any dose of corifollitropin alfa.
Skin and subcutaneous tissue disorders Acne	5.6% 1/18 • Number of events 1 • Up to Week 57 The Safety Analysis was based on the ASaT population, which consisted of all participants who received any dose of corifollitropin alfa.
Skin and subcutaneous tissue disorders Alopecia	5.6% 1/18 • Number of events 1 • Up to Week 57 The Safety Analysis was based on the ASaT population, which consisted of all participants who received any dose of corifollitropin alfa.
Skin and subcutaneous tissue disorders Hyperhidrosis	5.6% 1/18 • Number of events 1 • Up to Week 57 The Safety Analysis was based on the ASaT population, which consisted of all participants who received any dose of corifollitropin alfa.
Vascular disorders Flushing	5.6% 1/18 • Number of events 1 • Up to Week 57 The Safety Analysis was based on the ASaT population, which consisted of all participants who received any dose of corifollitropin alfa.
Investigations Blood testosterone decreased	11.1% 2/18 • Number of events 2 • Up to Week 57 The Safety Analysis was based on the ASaT population, which consisted of all participants who received any dose of corifollitropin alfa.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER