MenopausePhase 4NCT05057546

Ovarian Hormone Regulation of Central and Cerebrovascular Hemodynamics (NoMEN Study)

A Phase 4 study testing GnRH antagonist in people with Menopause and Estrogen Deficiency, run by University of Colorado, Denver at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 years, women onlyHealthy volunteers can take part
Conditions the study is for: Menopause, Estrogen Deficiency, Women
What is being tested?: GnRH antagonist
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 55 participants
Where: 1 siteUnited States
Study dates: 22 Nov 2021to 28 Jul 2025
Phase: Phase 4
Are there results?: Not yet: the study is under way

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 65 years
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

None listed.

Who cannot join

Seated resting blood pressure >140/90 mmHg
Use of medications that might influence cardiovascular function or cerebral blood flow;
Pregnant, currently breastfeeding or intention to become pregnant in the next 6 months;
Use of menopausal therapy or hormonal contraceptives, etc. within the previous 3 months or intent to start during the study period;
BMI >39 kg/m2;
Vigorous intensity exercise >2 days per week;

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Any current or past history of systemic illness that would interfere with study outcomes such as: diabetes, cancer (other than melanoma), liver, gallbladder disease, peripheral artery disease or thromboembolism, neurological disease, CVD or cerebrovascular disease;
Abnormal thyroid, liver, or kidney function testing during the screening examination or bloodwork;
Plasma glucose >126 mg/dl under fasting conditions;
Smoking or living with a smoker within the past 12 months;
Current or planned participation in an interventional study during the present study or unwillingness to complete study-related procedures;
Patients who report active acute systemic infection (e.g., flu, common cold, etc), fever (> 100.0 °F) or feeling ill will be asked to delay vascular testing until they are no longer febrile or ill. Additionally, anyone who has experienced a serious illness (requiring hospitalization) within the last 6 months, had a confirmed positive COVID test and hospitalized, or anyone with a confirmed positive COVID test within the last 6 months will be ineligible to participate (discretion of the study PI and MD).
No use of vitamin/supplements or chronic use of anti-inflammatory medications, or willingness to stop 1 month prior to the vascular visit.
In premenopausal women participating in the intervention:
Contraindications to Degarelix including hypersensitivity to degarelix acetate, extrinsic peptide hormones, mannitol, GnRH, benzyl alcohol (the vehicle for injection of degarelix acetate)
Undiagnosed vaginal bleeding
Osteopenia or osteoporosis (i.e., proximal femur or lumbar spine DXA Z scores <-1.0)
CES-D score ≥16 (unless clinician follow-up and clinical judgement determine they are eligible (will be noted in study chart)

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Colorado Denver Anschutz Medical Campus
Aurora, Colorado, 80045

Other trials in United States

About this study

Official title: Ovarian Hormone Regulation of Central and Cerebrovascular Hemodynamics

This study will evaluate changes in blood vessels around the heart (e.g., aorta and carotid arteries) and in the brain with the loss of female sex hormones (e.g., estrogen) during the menopause transition. The menopause transition is associated with declines in blood vessel function and increased risk for cardiovascular disease and Alzheimer's disease. Increasing evidence supports an early role for declines in blood vessel function and future development of Alzheimer's disease in aging men and women. This study will learn about the effects of changes in female sex hormones, such as estrogen, during the menopause transition on blood vessel around the heart and in the brain in women.

Conditions: Menopause, Estrogen Deficiency, Women, Aging
Being tested: GnRH antagonist

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GnRH antagonistDrug
Also called Degarelix acetate
GnRH antagonist will be given once for premenopausal women (12-week intervention) and twice for postmenopausal women (24-week intervention)

Study groups in NCT05057546
Study group	Role	What they receive
Premenopausal Group: GnRH antagonist	Experimental	Gonadotropin releasing hormone (GnRH) antagonist is degarelix acetate, 80 mg, delivered once as a subcutaneous injection. Receives: Drug: GnRH antagonist

What is being measured

The primary outcome is the main question the study is designed to answer.

Aortic stiffness and pulsatile hemodynamics
Aortic characteristic impedance and forward pressure wave amplitude
Measured: Change from baseline at 12 weeks

Secondary outcomes (4)

Common carotid artery stiffness and pulsatile hemodynamics
Carotid characteristic impedance and forward pressure wave amplitude
Measured: Change from baseline at 12 weeks
Macrovascular cerebral blood flow
Cerebral blood flow measured by transcranial Doppler
Measured: Change from baseline at 12 weeks
Macrovascular cerebrovascular reserve
Breath hold index measured by transcranial Doppler
Measured: Change from baseline at 12 weeks
Microvascular cerebral blood flow
Cerebral blood flow measured by Arterial Spin Labeling Magnetic Resonance Imaging
Measured: Change from baseline at 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Nov 202128 Jul 2025

First posted27 Sep 2021
Study start22 Nov 2021
Primary completion18 Sep 2024
Study completion28 Jul 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for MenopauseStudies of the same condition, open and under way.
More trials run by University of Colorado, DenverThe 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: Phase 4
Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Model description: BESH clinical trial
Masking: None (open label)
Enrolment: 55 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05057546
Sponsor's protocol ID: 21-3590
Status last verified: Mar 2025
First submitted: 16 Sep 2021
Last updated: 27 Mar 2025
Results posted: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Ovarian Hormone Regulation of Central and Cerebrovascular Hemodynamics
ClinicalTrials.gov ID: NCT05057546
Acronym / sponsor ID: 21-3590
Conditions: Menopause, Estrogen Deficiency, Women, Aging
Phase: Phase 4
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 55 participants (estimated)
Lead sponsor: University of Colorado, DenverUniversity, hospital or other
Study start: 22 Nov 2021 (actual)
Primary completion: 18 Sep 2024 (actual)
Study completion: 28 Jul 2025 (estimated)
First posted: 27 Sep 2021 (actual)
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.

Study design

Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: BESH clinical trial

Arm	Type	Receives
Premenopausal Group: GnRH antagonist	Experimental	Drug: GnRH antagonistGonadotropin releasing hormone (GnRH) antagonist is degarelix acetate, 80 mg, delivered once as a subcutaneous injection.

Who may qualify

Ages: 18 to 65 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (0 listed)

Key exclusion criteria (18 listed)

Seated resting blood pressure >140/90 mmHg
Use of medications that might influence cardiovascular function or cerebral blood flow;
Pregnant, currently breastfeeding or intention to become pregnant in the next 6 months;
Use of menopausal therapy or hormonal contraceptives, etc. within the previous 3 months or intent to start during the study period;
BMI >39 kg/m2;

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
GnRH antagonistAlso: Degarelix acetateGnRH antagonist will be given once for premenopausal women (12-week intervention) and twice for postmenopausal women (24-week intervention)	Drug	Premenopausal Group: GnRH antagonist

Primary outcome

Aortic stiffness and pulsatile hemodynamics
Time frame: Change from baseline at 12 weeks
Aortic characteristic impedance and forward pressure wave amplitude

4 secondary outcomes

Common carotid artery stiffness and pulsatile hemodynamics
Time frame: Change from baseline at 12 weeks
Macrovascular cerebral blood flow
Time frame: Change from baseline at 12 weeks
Macrovascular cerebrovascular reserve
Time frame: Change from baseline at 12 weeks
Microvascular cerebral blood flow
Time frame: Change from baseline at 12 weeks

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
Individual participant dataSharing planned: No

Related trials for Menopause

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Hop Extract Versus Soy Isoflavone Extract for Menopausal Symptoms (HOPES)
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Active, not recruitingPhase 3
Human Menopausal Gonadotropin Research in Infertility Assessing Cumulative Live Birth With Frozen Embryo Transfer.
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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.

Lyndsey DuBose, PhD principal investigator

University of Colorado Denver Anschutz Medical Campus

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing GnRH antagonist in people with Menopause and Estrogen Deficiency, run by University of Colorado, Denver 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 0 inclusion and 18 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: under way, not looking for participants, as of the sponsor's last update on 27 Mar 2025. 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?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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?

Aortic stiffness and pulsatile hemodynamics (time frame: Change from baseline at 12 weeks). 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 NCT05057546.

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 27 Mar 2025.