NCT02042638

Brief Summary

Effects of hCG replacement therapy on metabolic syndrome parameters in hypogonadotrophic hypogonadism.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

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

January 1, 2011

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 28, 2013

Completed
26 days until next milestone

First Posted

Study publicly available on registry

January 23, 2014

Completed
Last Updated

January 23, 2014

Status Verified

December 1, 2013

Enrollment Period

2.6 years

First QC Date

December 28, 2013

Last Update Submit

January 22, 2014

Conditions

Idiopathic Hypogonadotropic Hypogonadism

Outcome Measures

Primary Outcomes (3)

  • HDL after hCG treatment

    2011-2013

    2011-2013

  • LDL levels after hCG treatment

    2011-2013

  • total cholesterole levels after hCG treatment

    2011-2013

Secondary Outcomes (2)

  • Body fat ratio after hCG treatment

    2011-2013

  • hsCRP levels after hCG treatment

    2011-2013

Study Arms (1)

16 treatment naive Hypogonadotropic hypogonadism patients

Treatment naive 16 patients with idiopathic hypogonadotrophic hypogonadism

Drug: hCG 1500 IU three times a weekDrug: Pregnyl (hCG) ampule 1500 IU/three times a week

Interventions

hCG 1500 IU three times a weekDRUG
Also known as: Pregnyl (Organon) ampule 1500 IU
16 treatment naive Hypogonadotropic hypogonadism patients
Pregnyl (hCG) ampule 1500 IU/three times a weekDRUG
16 treatment naive Hypogonadotropic hypogonadism patients

Eligibility Criteria

Age16 Years - 45 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Patients with Idiopathic Hypogonadotropic Hypogonadism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gulhane School of Medicine Dep. of Endocrinology and Metabolism

Ankara, 06018, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Idiopathic Hypogonadotropic Hypogonadism

Interventions

Chorionic Gonadotropin

Intervention Hierarchy (Ancestors)

GonadotropinsPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPlacental HormonesPeptidesAmino Acids, Peptides, and ProteinsPregnancy ProteinsProteins

Study Officials

  • Fahri Bayram, Proffesor

    Erciyes University School of Medicine Depatment of Endocrinology and Metabolism Kayseri TURKEY

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

December 28, 2013

First Posted

January 23, 2014

Study Start

January 1, 2011

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

January 23, 2014

Record last verified: 2013-12

Locations

TU(1)