An Early Phase 1 interventional study of ganirelix acetate and methyl testosterone in Polycystic Ovary Syndrome, sponsored by Yale University. Completed at 1 site in United States. Open to female participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-07-04.
Sponsored by Yale University · Early Phase 1, Interventional, and Basic science
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.
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.
975 studies on the registry are indexed under Polycystic Ovary Syndrome; 177 are open to participants now.
This study's enrollment of 28 is below the median of 70 across 710 interventional studies indexed under Polycystic Ovary Syndrome.
Browse Polycystic Ovary Syndrome studies →Yale University is the lead sponsor of 1,763 studies on the registry; 292 are open to participants now.
Of its 217 completed or terminated interventional studies of FDA-regulated products, 128 (59%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
GNRH antagonist alone
Drug: ganirelix acetate
GnRH with Testosterone
Drug: methyl testosterone
GnRH antagonist, subcutaneous injection, 0.25 mg/day for 21 days
Also known as: Antagon
testosterone, oral administration, day 5 of GnRH administration, 2.5 mg/day
Skin blood flow and cutaneous vascular conductance
Time frame: 6 non consecutive days
This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drugs tested here: Ganirelix · Methyltestosterone