NCT02728440

Brief Summary

Effects of gonadotrophin replacement therapy Lipid Profile and Oxidative Stress Parameters of Patients with Idiopathic Hypogonadotropic Hypogonadism

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2010

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

March 27, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 5, 2016

Completed
Last Updated

April 13, 2016

Status Verified

March 1, 2016

Enrollment Period

2.6 years

First QC Date

March 27, 2016

Last Update Submit

April 11, 2016

Conditions

Idiopathic Hypogonadotropic Hypogonadism

Outcome Measures

Primary Outcomes (3)

  • oxidative stress after hCG and HMG treatment

    2010-2012

  • HDL levels after hCG treatment

    2010-2012

  • total cholesterole levels after hCG treatment

    2010-2012

Study Arms (1)

Hypogonadotropic hypogonadism patients

30 patients with idiopathic hypogonadotrophic hypogonadism

Drug: human chorionic gonadotropin, human menopausal gonadotropin

Interventions

human chorionic gonadotropin, human menopausal gonadotropinDRUG

drug for the treatment of male hypogonadism

Also known as: Pregnyl ® Organon hCG 1500 IU, Merional ® ARIS 75 IU
Hypogonadotropic hypogonadism patients

Eligibility Criteria

Age22 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Patients with Idiopathic Hypogonadotropic Hypogonadism and healthy control group

You may qualify if:

  • Serum testosterone concentration \< 300ng/dL Absence of a pituitary or hypothalamic mass lesions, Presence of gonadotropin response to GnRH, -

You may not qualify if:

  • diabetes mellitus, arterial hypertension other hormone deficiencies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Idiopathic Hypogonadotropic Hypogonadism

Interventions

Chorionic GonadotropinMenotropins

Intervention Hierarchy (Ancestors)

GonadotropinsPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPlacental HormonesPeptidesAmino Acids, Peptides, and ProteinsPregnancy ProteinsProteinsGonadotropins, PituitaryPituitary Hormones, AnteriorPituitary HormonesBiological ProductsComplex Mixtures

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 27, 2016

First Posted

April 5, 2016

Study Start

May 1, 2010

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

April 13, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share