NCT00757185

Brief Summary

The scientific aims of the study are to determine how peripheral microcirculatory responsiveness is altered in obese women with Polycystic Ovary Syndrome (PCOS) during local heating and to determine the mechanism for testosterone effects on peripheral microcirculatory responsiveness in women with PCOS.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Feb 2008

Longer than P75 for early_phase_1

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

February 1, 2008

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 22, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 23, 2008

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

July 4, 2016

Status Verified

July 1, 2016

Enrollment Period

4.2 years

First QC Date

September 22, 2008

Last Update Submit

July 1, 2016

Conditions

Polycystic Ovary Syndrome

Keywords

skin blood flowmicrocirculation

Outcome Measures

Primary Outcomes (1)

  • Skin blood flow and cutaneous vascular conductance

    6 non consecutive days

Study Arms (2)

1

EXPERIMENTAL

GNRH antagonist alone

Drug: ganirelix acetate

2

EXPERIMENTAL

GnRH with Testosterone

Drug: methyl testosterone

Interventions

ganirelix acetateDRUG

GnRH antagonist, subcutaneous injection, 0.25 mg/day for 21 days

Also known as: Antagon
1
methyl testosteroneDRUG

testosterone, oral administration, day 5 of GnRH administration, 2.5 mg/day

2

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Obese women (18-35) years with and without PCOS

You may not qualify if:

  • Conditions that would preclude safe use of hormones

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

John B. Pierce Laboratory

New Haven, Connecticut, 06520, United States

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

ganirelixMethyltestosterone

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

TestosteroneAndrostenolsAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Nina Stachenfeld, PhD

    John B. Pierce Laboratory

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2008

First Posted

September 23, 2008

Study Start

February 1, 2008

Primary Completion

April 1, 2012

Study Completion

December 1, 2012

Last Updated

July 4, 2016

Record last verified: 2016-07

Locations

US(1)