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NCT00757185·Early Phase 1·INTERVENTIONAL

Compromised Microcirculation in Women With Polycystic Ovary Syndrome

GanirelixOtherCompleted

Status

Completed

Phase

Early Phase 1

Enrollment

28

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Full detailed description

In these studies, we propose to use the skin as a relatively non-invasive model to examine cardiovascular and endothelial function in obese women with and without PCOS. Data have indicated an important role for testosterone in influencing the peripheral microcirculation. While testosterone can lead to vasodilation in the peripheral microcirculation in both men and in women without PCOS, testosterone appears to induce vasoconstriction in women with PCOS. The differential response between women with and without PCOS, and between men and women may be the result of differential ET-1 actions in the vessel, and regulated by the receptor subtype is involved in these actions.

Interventions

Treatment arms and agents.

DRUG

ganirelix acetate

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

DRUG

methyl testosterone

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

Timeline

From registration to results.

  1. First posted

    Sep 23, 2008

  2. Study start

    Feb 2008

  3. Primary completion

    Apr 2012

  4. Study completion

    Dec 2012

  5. Results posted

    Not reported

  6. Registry updated

    Jul 4, 2016

Outcomes

What the study measures.

Primary outcomes

Skin blood flow and cutaneous vascular conductance

Time frame · 6 non consecutive days

Secondary outcomes

Not reported in the indexed record.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
35 Years
Sex
FEMALE
Healthy volunteers
Yes

Inclusion Criteria: * Obese women (18-35) years with and without PCOS Exclusion Criteria: * Conditions that would preclude safe use of hormones

Study locations

1 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

John B. Pierce Laboratory

New Haven, Connecticut, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

ClinicalTrials.gov ↗Search PubMed ↗Search FDA ↗Search EMA ↗

Related trials

More studies on Ganirelix.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.

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