Polycystic Ovary SyndromeEarly Phase 1NCT00757185
Compromised Microcirculation in Women With Polycystic Ovary Syndrome
A Early Phase 1 study testing ganirelix acetate and methyl testosterone in people with Polycystic Ovary Syndrome, run by Yale University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- ganirelix acetate and methyl testosterone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to Dec 2012
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Obese women (18-35) years with and without PCOS
Who cannot join
- Conditions that would preclude safe use of hormones
Trial locations and contacts
1 site in 1 country.
United States1 site
John B. Pierce Laboratory
New Haven, Connecticut, 06520
About this study
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.
Read the 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.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- ganirelix acetate, methyl testosterone
- Keywords
- skin blood flow, microcirculation
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ganirelix acetateDrug
Also called Antagon
GnRH antagonist, subcutaneous injection, 0.25 mg/day for 21 days
methyl testosteroneDrug
testosterone, oral administration, day 5 of GnRH administration, 2.5 mg/day
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | GNRH antagonist alone Receives: Drug: ganirelix acetate |
| 2 | Experimental | GnRH with Testosterone Receives: Drug: methyl testosterone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin blood flow and cutaneous vascular conductance
Measured: 6 non consecutive days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2008 (estimated)
- Study startFeb 2008
- Primary completionApr 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Nina Stachenfeld, PhD, Principal investigator, John B. Pierce Laboratory
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00757185
- Sponsor's protocol ID
- 0801003437
- Other IDs
- R21HL093450
- Status last verified
- Jul 2016
- First submitted
- 22 Sep 2008
- Last updated
- 4 Jul 2016
- Results posted
- No
Publications
Young BE, Colburn A, Oldham ZR, Berbrier D, Usselman CW, Stone T, Fadel PJ, Stachenfeld NS. Combined androgen excess polycystic ovary syndrome and obesity are associated with elevated beat-to-beat blood pressure variability in adult women. Am J Physiol Heart Circ Physiol. 2026 Aug 1;331(2):H374-H381. doi: 10.1152/ajpheart.00275.2026. Epub 2026 Jun 15.
PubMed 42294856
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compromised Microcirculation in Women With Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT00757185
- Acronym / sponsor ID
- 0801003437
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- skin blood flow, microcirculation
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Feb 2008
- Primary completion
- Apr 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 23 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: ganirelix acetateGNRH antagonist alone |
| 2 | Experimental | Drug: methyl testosteroneGnRH with Testosterone |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Obese women (18-35) years with and without PCOS
Key exclusion criteria (1 listed)
- Conditions that would preclude safe use of hormones
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ganirelix acetateAlso: AntagonGnRH antagonist, subcutaneous injection, 0.25 mg/day for 21 days | Drug | 1 |
| methyl testosteronetestosterone, oral administration, day 5 of GnRH administration, 2.5 mg/day | Drug | 2 |
Primary outcome
Skin blood flow and cutaneous vascular conductance
Time frame: 6 non consecutive days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2016.
- Derived from this study: PubMed 42294856Young BE, Colburn A, Oldham ZR, Berbrier D, Usselman CW, Stone T, Fadel PJ, Stachenfeld NS. Combined androgen excess polycystic ovary syndrome and obesity are associated with elevated beat-to-beat blood pressure variability in adult women. Am J Physiol Heart Circ Physiol. 2026 Aug 1;331(2):H374-H381. doi: 10.1152/ajpheart.00275.2026. Epub 2026 Jun 15.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nina Stachenfeld, PhD principal investigator
John B. Pierce Laboratory
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing ganirelix acetate and methyl testosterone in people with Polycystic Ovary Syndrome, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin blood flow and cutaneous vascular conductance (time frame: 6 non consecutive days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00757185, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jul 2016.