Cognitive ImpairmentNCT03112226
Effects of Ovarian Hormone Suppression on Vascular and Cognitive Function
A study testing GnRHant + E2 in people with Cognitive Impairment and Estrogen Deficiency, run by University of Colorado, Denver at 2 sites in United States.
Trial summary
Complaints about memory and thinking are common in women as they go through menopause. The female hormone estrogen is important for both the health of both the brain and the blood vessels. In Alzheimer's disease there is damage to the blood vessels in the brain. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cognitive Impairment, Estrogen Deficiency, Menopause
- What is being tested?
- GnRHant + E2
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 2 sitesUnited States
- Study dates
- 7 Feb 2018to 21 Jun 2020
- Phase
- Interventional
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Stages of Reproductive Aging Workshop (STRAW+10) peak or late reproductive stage (-4, -3b or -3a)
- Healthy based on medical history, physical examination and standard blood chemistries
- Normotensive (resting blood pressure <140/90 mmHg)
- Normoglycemia (fasting glucose <110mg/dl and hemoglobin A1c<6.5%)
- Non-smoker (for at least 12 months)
Who cannot join
- Serum Follical Stimulating Hormone (FSH) >25mIU/mL measured during the first 5 days of the menstrual cycle
- Use of hormonal therapy within the past 3 months
- Use of antihypertensive or lipid-lowering medications
- Pregnant or lactating, or planning to become pregnant during the study period
- Known hypersensitivity to any of the study medications
- Abnormal vaginal bleeding
Show all 14Show fewer
- History of venous thromboembolism or hormone-sensitive cancer
- History of neurologic disease or major psychiatric illness
- History of diagnosed learning disability or less than high-school education
- Contraindication to Magnetic Resonance Imaging (MRI) scanning
- Depression (Center for Epidemiological Studies - Depression (CESD) score >16)
- Significant cognitive impairment (Mini Mental State Examination (MMSE) score <27)
- Severe osteopenia or osteoporosis (proximal femur or lumbar spine T-score < -2.0)
- Body Mass Index (BMI) >40kg/m2
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
University of Colorado Boulder Intermountain Neuroimaging Consortium
Boulder, Colorado, 80309
About this study
Complaints about memory and thinking are common in women as they go through menopause. The female hormone estrogen is important for both the health of both the brain and the blood vessels. In Alzheimer's disease there is damage to the blood vessels in the brain. This study will look at how the loss of the female hormone estrogen affects brain function and the health of blood vessels.
- Conditions
- Cognitive Impairment, Estrogen Deficiency, Menopause, Endothelial Dysfunction, Vascular Stiffness
- Being tested
- GnRHant + E2, GnRHant + Placebo
- Keywords
- cognitive impairment, menopause, estrogen, functional MRI, executive function, endothelial function, arterial stiffness
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GnRHant + E2Other
Also called Degarelix acetate, Firmagon + Estradiol, Climara transdermal system
GnRH antagonist with estradiol add-back
GnRHant + PlaceboOther
Also called Degarelix acetate, Firmagon
GnRH antagonist with placebo add-back
| Study group | Role | What they receive |
|---|---|---|
| GnRHant + E2 | Active comparator | Single dose of GnRH antagonist degarelix acetate for depot injection (80mg) Transdermal estradiol add-back; Climara patch, 0.075mg/day, weekly for 12 weeks Receives: Other: GnRHant + E2 |
| GnRHant + Placebo | Placebo comparator | Single dose of GnRH antagonist degarelix acetate for depot injection (80mg) Transdermal placebo patch, weekly for 12 weeks Receives: Other: GnRHant + Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Prefrontal cortex brain activation
Changes in patterns of brain activation in the prefrontal cortex using functional magnetic resonance imaging (fMRI) during a task of working memory will be measured at baseline and 3 months
Measured: Baseline, 3 months
Secondary outcomes (3)
Changes in Endothelial function
Endothelial function will be measured using brachial artery flow-mediated dilation at baseline and 3 months
Measured: Baseline, 3 months
Changes in Arterial stiffness
Carotid artery compliance will be measured using ultrasound at baseline and 3 months
Measured: Baseline, 3 months
Changes in Executive cognitive function
Changes in executive cognitive function on a battery of neuropsychological tests will be measured at baseline and 3 months
Measured: Baseline, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2017
- Study start7 Feb 2018
- Primary completion6 Jun 2020
- Study completion21 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ImpairmentStudies 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kerry L Hildreth, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03112226
- Sponsor's protocol ID
- 17-0092
- Status last verified
- Jun 2021
- First submitted
- 7 Apr 2017
- Last updated
- 7 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Ovarian Hormone Suppression on Vascular and Cognitive Function
- ClinicalTrials.gov ID
- NCT03112226
- Acronym / sponsor ID
- 17-0092
- Conditions
- Cognitive Impairment, Estrogen Deficiency, Menopause, Endothelial Dysfunction, Vascular Stiffness
- Keywords
- cognitive impairment, menopause, estrogen, functional MRI, executive function, endothelial function, arterial stiffness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 7 Feb 2018 (actual)
- Primary completion
- 6 Jun 2020 (actual)
- Study completion
- 21 Jun 2020 (actual)
- First posted
- 13 Apr 2017 (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.
Complaints about memory and thinking are common in women as they go through menopause. The female hormone estrogen is important for both the health of both the brain and the blood vessels. In Alzheimer's disease there is damage to the blood vessels in the brain. This study will look at how the loss of the female hormone estrogen affects brain function and the health of blood vessels.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GnRHant + E2 | Active comparator | Other: GnRHant + E2Single dose of GnRH antagonist degarelix acetate for depot injection (80mg) Transdermal estradiol add-back; Climara patch, 0.075mg/day, weekly for 12 weeks |
| GnRHant + Placebo | Placebo comparator | Other: GnRHant + PlaceboSingle dose of GnRH antagonist degarelix acetate for depot injection (80mg) Transdermal placebo patch, weekly for 12 weeks |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Stages of Reproductive Aging Workshop (STRAW+10) peak or late reproductive stage (-4, -3b or -3a)
- Healthy based on medical history, physical examination and standard blood chemistries
- Normotensive (resting blood pressure <140/90 mmHg)
- Normoglycemia (fasting glucose <110mg/dl and hemoglobin A1c<6.5%)
- Non-smoker (for at least 12 months)
Key exclusion criteria (14 listed)
- Serum Follical Stimulating Hormone (FSH) >25mIU/mL measured during the first 5 days of the menstrual cycle
- Use of hormonal therapy within the past 3 months
- Use of antihypertensive or lipid-lowering medications
- Pregnant or lactating, or planning to become pregnant during the study period
- Known hypersensitivity to any of the study medications
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 |
|---|---|---|
| GnRHant + E2Also: Degarelix acetate, Firmagon + Estradiol, Climara transdermal systemGnRH antagonist with estradiol add-back | Other | GnRHant + E2 |
| GnRHant + PlaceboAlso: Degarelix acetate, FirmagonGnRH antagonist with placebo add-back | Other | GnRHant + Placebo |
Primary outcome
Changes in Prefrontal cortex brain activation
Time frame: Baseline, 3 months
Changes in patterns of brain activation in the prefrontal cortex using functional magnetic resonance imaging (fMRI) during a task of working memory will be measured at baseline and 3 months
3 secondary outcomes
Changes in Endothelial function
Time frame: Baseline, 3 months
Changes in Arterial stiffness
Time frame: Baseline, 3 months
Changes in Executive cognitive function
Time frame: Baseline, 3 months
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 7 Jun 2021.
- Individual participant dataSharing planned: No
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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.
Kerry L Hildreth, MD principal investigator
University of Colorado, Denver
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GnRHant + E2 in people with Cognitive Impairment and Estrogen Deficiency, run by University of Colorado, Denver at 2 sites 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 5 inclusion and 14 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 7 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Changes in Prefrontal cortex brain activation (time frame: Baseline, 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jun 2021.