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Efficacy and Safety of Long Term Use of hCG or hCG Plus hMG in Males With Isolated Hypogonadotropic Hypogonadism (IHH)

NCT03687606 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2020-04-08

No results posted yet for this study

Summary

This study will evaluate the efficacy and safety of long term use of hCG alone or hCG plus hMG in the treatment of male patients with isolated hypogonadotropic hypogonadism (IHH). One third of the participants will receive hCG treatment alone and the other third of the participants will receive hCG treatment alone for six months, then the hMG will be added. And the last third of the participants will receive hCG and hMG treatment since the beginning of the treatment.

Conditions

  • Isolated Hypogonadotropic Hypogonadism
  • Kallmann Syndrome
  • Infertility

Interventions

DRUG

Human Chorionic Gonadotropin

White freeze-dried cake or powder with specifications of 1000U, 2000U, 5000U.

DRUG

human menopausal gonadotropin

White freeze-dried cake or powder with specification of 75IU.

Sponsors & Collaborators

  • Tongji Hospital

    lead OTHER

Principal Investigators

  • Jihong Liu, M.D · Departments of Urology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-18
Primary Completion
2024-10-01
Completion
2025-10-01

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03687606 on ClinicalTrials.gov