NCT00473603

Brief Summary

The purpose of this study is to determine whether free fatty acids modify the androgen levels in healthy young women.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2006

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

December 1, 2006

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 14, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 15, 2007

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

January 25, 2018

Status Verified

January 1, 2018

Enrollment Period

1.4 years

First QC Date

May 14, 2007

Last Update Submit

January 23, 2018

Conditions

HyperandrogenismGlucocorticoid Metabolism

Keywords

androgensfatty acids

Outcome Measures

Primary Outcomes (4)

  • change of DHEA

    Measurement of serum DHEA

    1 day

  • change of DHEAS

    Measurement of serum DHEAS

    1 day

  • change of testosterone

    Measurement of serum testosterone

    1 day

  • change of androstenedione

    Measurement of serum androstenedione

    1 day

Secondary Outcomes (4)

  • urinary androgen excretion

    1 day

  • urinary cortisol excretion

    1 day

  • urinary cortisone excretion

    1 day

  • changes in metabolic parameters (e.g. FGF-21)

    1 day

Study Arms (2)

LHI

EXPERIMENTAL

to perform an i.v. lipid heparin infusion for 4 h

Drug: lipid/heparin infusion

SHI

SHAM COMPARATOR

to perform an i.v. saline heparin infusion for 4 h

Drug: lipid/heparin infusion

Interventions

lipid/heparin infusionDRUG

to perform an i.v. lipid heparin infusion infusion for 4 h

LHISHI

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy men and women

You may not qualify if:

  • diabetes mellitus or impaired glucose tolerance
  • clinical signs of hyperandrogenism
  • polycystic ovary
  • hormonal therapy
  • BMI \> 30 kg/m2
  • dysmenorrhoea

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charite, Campus Benjamin Franklin

Berlin, Germany

Location

MeSH Terms

Conditions

Hyperandrogenism

Interventions

Lipids

Condition Hierarchy (Ancestors)

46, XX Disorders of Sex DevelopmentDisorders of Sex DevelopmentUrogenital AbnormalitiesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesAdrenogenital SyndromeMale Urogenital DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGonadal DisordersEndocrine System Diseases

Study Officials

  • Knut Mai, MD

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

May 14, 2007

First Posted

May 15, 2007

Study Start

December 1, 2006

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

January 25, 2018

Record last verified: 2018-01

Locations

DE(1)