MenopausePhase 4BEAMNCT04043520
Bioenergetic Effects of Aging and Menopause (BEAM)
A Phase 4 study testing GnRH antagonist and Estrogen Product in people with Menopause and Obesity, Abdominal, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The menopause transition is associated with increased risk for weight gain and a shift toward storing fat in the belly region, which may increase risk for cardiovascular disease and diabetes. The study will determine whether the stress hormone cortisol contributes to this shift. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause, Obesity, Abdominal, Aging
- What is being tested?
- GnRH antagonist and Estrogen Product
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Sep 2019to 31 Aug 2024
- 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 40 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Volunteers will be healthy peri/postmenopausal women who are willing and able to undergo the proposed hormone manipulation and study procedures. Women will be at least 6 months but not more than 7 years past the last menstrual period (i.e., late perimenopausal or early postmenopausal) with FSH >30 IU/L. We will make a major effort to ensure that the women enrolled in this study come from all races and ethnicities and a wide range of socioeconomic and educational levels. Women will be excluded for the reasons listed below.
Who cannot join
- abnormal vaginal bleeding
- on hormonal contraceptive or menopausal therapy or intention to start during the period of study
- positive pregnancy test or intention to become pregnant during the period of study
- lactation
- known hypersensitivity to degarelix acetate, estradiol, or medroxyprogesterone acetate
- Center for Epidemiological Studies Depression Scale (CES-D) score <,16 (unless clinician follow-up and clinical judgement determine they are eligible (will be noted in study chart)
Show all 18Show fewer
- current tobacco and/or vape use more than 2 times/week
- current marijuana or tetrahydrocannabinol (THC) use in any form more than 3 times/week
- regular self-reported alcohol consumption >14 drinks/week
- BMI >39 kg/m2
- use of glucocorticoids or drugs that affect glucocorticoid metabolism (e.g., ketoconazole)
- severe osteopenia or osteoporosis, defined as femoral neck or lumbar spine t-score <-2.0
- thyroid dysfunction, defined as an ultrasensitive TSH <0.5 or >5.0 mU/L; volunteers with abnormal thyroid stimulating hormone (TSH) values will be re-considered for participation in the study after follow-up evaluation by the PCP with initiation or adjustment of thyroid hormone replacement
- liver dysfunction, defined as liver function tests (AST, ALT) >1.5 times the upper limit of normal
- uncontrolled hypertension defined as resting systolic BP >150 mmHg or diastolic BP>90 mmHg; participants who do not meet these criteria at first screening will be re-evaluated, including after follow-up evaluation by the primary care provider (PCP) with initiation or adjustment of anti-hypertensive medications
- self-reported history of breast cancer or other estrogen-dependent neoplasms
- self-reported history of venous thromboembolism, pulmonary embolism, or other thromboembolic disorder
- self-reported history of cardiovascular disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Colorado - Anschutz Medical Campus
Aurora, Colorado, 80045
Wendy M Kohrt, PhD, 303-724-1913, wendy.kohrt@cuanschutz.edu
Wendy M Kohrt, PhD
About this study
Official title: Bioenergetic and Metabolic Consequences of the Loss of Ovarian Function in Women - 2018
The menopause transition is associated with increased risk for weight gain and a shift toward storing fat in the belly region, which may increase risk for cardiovascular disease and diabetes. The study will determine whether the stress hormone cortisol contributes to this shift.
Read the detailed description
The menopause transition is associated with increased risk for weight gain and a shift toward storing fat in the belly region, which may increase risk for cardiovascular disease and diabetes. The stress hormone cortisol is known to promote the accumulation of belly fat, and there is evidence that low estrogen is associated with higher cortisol levels. The first aim of the study is to determine whether low estrogen levels in premenopausal and early postmenopausal women increase cortisol levels in the blood and in fat tissue. When estrogen level decreases at the time of menopause, there is an increase in follicle-stimulating hormone, or FSH. Recent evidence in mice suggests that blocking FSH prevents the increase in belly fat. The second aim of the study is to determine whether decreasing the high FSH level in postmenopausal women causes a decrease in belly fat and changes other factors that are typically thought to be related to estrogen rather than FSH. Because estrogen and FSH levels fluctuate in premenopausal and early postmenopausal women, the investigators will use an approach that controls estrogen and FSH levels to address the aims. The investigators will use a drug that is typically used to treat endometriosis or uterine fibroids to reduce estrogen and FSH levels and an estrogen patch to increase estrogen in some women. The study will generate new knowledge on how menopause affects fat gain and disease risk.
- Conditions
- Menopause, Obesity, Abdominal, Aging, Weight Gain
- Being tested
- GnRH antagonist, Estrogen Product, Placebo estradiol, Placebo GnRH antagonist
- Medical subject headings
- Obesity, Abdominal, Weight Gain
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)
Estrogen ProductDrug
Also called Estrogen transdermal patch
Estrogen patches will be worn by those randomized to the Estradiol arms in both premenopausal and postmenopausal groups. Patches will be applied weekly and will be worn for the for entirety of the intervention (12 or 24 weeks).
Placebo estradiolDrug
Also called Placebo transdermal patch
Placebo patches will be worn by those randomized to the placebo arms in both premenopausal and postmenopausal groups. Patches will be applied weekly and will be worn for the for entirety of the intervention (12 or 24 weeks).
Placebo GnRH antagonistDrug
Also called Placebo injection
Postmenopausal women randomized to the placebo injection arm will receive two placebo drug injections of normal saline (24-week intervention)
| Study group | Role | What they receive |
|---|---|---|
| Postmenopausal: GnRH antagonist + estradiol | Experimental | GnRH antagonist is degarelix acetate, 80 mg, delivered twice as a subcutaneous injection (at baseline and after 12 weeks)
Estradiol is a transdermal patch 0.075 mg, applied weekly for 24 weeks Receives: Drug: GnRH antagonist; Drug: Estrogen Product |
| Postmenopausal: GnRH antagonist + placebo | Experimental | GnRH antagonist is degarelix acetate, 80 mg, delivered twice as a subcutaneous injection (at baseline and after 12 weeks)
Placebo is a transdermal patch, applied weekly for 24 weeks Receives: Drug: GnRH antagonist; Drug: Placebo estradiol |
| Postmenopausal: placebo + placebo | Placebo comparator | Placebo (1) is normal saline, delivered twice as a subcutaneous injection (at baseline and after 12 weeks)
Placebo (2) is a transdermal patch, applied weekly for 24 weeks Receives: Drug: Placebo estradiol; Drug: Placebo GnRH antagonist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Microdialysis Cortisone Challenge (MCC) Index
The MCC Index is an in vivo measurement of local cortisol production in abdominal adipose tissue. A higher MCC Index is an indicator of more local cortisol production.
Measured: Baseline, week 12
Change in the Oral Cortisone Challenge (OCC) Area Under the Curve (AUC)
The OCC AUC is a systemic measurement of peripheral glucocorticoid metabolism. A higher OCC AUC is an indicator of more production of cortisol.
Measured: Baseline, week 12
Secondary outcomes (5)
Change in lumbar spine Bone Mineral Density (BMD)
Lumbar spine BMD is measured by dual-energy x-ray absorptiometry. A higher BMD is a general indicator of less risk for osteoporosis.
Measured: Baseline, week 24
Change in resting energy expenditure (REE)
REE is an index of metabolic rate at rest, measured by indirect calorimetry. A higher REE is an indicator of greater energy expenditure at rest.
Measured: Baseline, week 12, week 24
Change in visceral fat area (VFA)
VFA of the abdominal visceral region is measured by computed tomography. VFA is an indicator of the amount of fat stored in this region.
Measured: Baseline, week 24
Change in flow-mediated dilation (FMD)
FMD of the brachial artery as an index of vascular function. A higher number is a general indicator of better vascular function.
Measured: Baseline, week 12, week 24
Change in proximal femur Bone Mineral Density (BMD)
Proximal femur BMD is measured by dual-energy x-ray absorptiometry. A higher BMD is a general indicator of less risk for osteoporosis.
Measured: Baseline, week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2019
- Study start24 Sep 2019
- Primary completion31 Aug 2024 (estimated)
- Study completion31 Aug 2024 (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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 57 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Wendy M Kohrt, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04043520
- Sponsor's protocol ID
- 18-2483
- Other IDs
- U54AG062319
- Acronym
- BEAM
- Status last verified
- Dec 2023
- First submitted
- 25 Jun 2019
- Last updated
- 18 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioenergetic and Metabolic Consequences of the Loss of Ovarian Function in Women - 2018
- ClinicalTrials.gov ID
- NCT04043520
- Acronym / sponsor ID
- BEAM / 18-2483
- Conditions
- Menopause, Obesity, Abdominal, Aging, Weight Gain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 57 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 24 Sep 2019 (actual)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 2 Aug 2019 (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.
The menopause transition is associated with increased risk for weight gain and a shift toward storing fat in the belly region, which may increase risk for cardiovascular disease and diabetes. The study will determine whether the stress hormone cortisol contributes to this shift.
Detailed description
The menopause transition is associated with increased risk for weight gain and a shift toward storing fat in the belly region, which may increase risk for cardiovascular disease and diabetes. The stress hormone cortisol is known to promote the accumulation of belly fat, and there is evidence that low estrogen is associated with higher cortisol levels. The first aim of the study is to determine whether low estrogen levels in premenopausal and early postmenopausal women increase cortisol levels in the blood and in fat tissue. When estrogen level decreases at the time of menopause, there is an increase in follicle-stimulating hormone, or FSH. Recent evidence in mice suggests that blocking FSH prevents the increase in belly fat. The second aim of the study is to determine whether decreasing the high FSH level in postmenopausal women causes a decrease in belly fat and changes other factors that are typically thought to be related to estrogen rather than FSH. Because estrogen and FSH levels fluctuate in premenopausal and early postmenopausal women, the investigators will use an approach that controls estrogen and FSH levels to address the aims. The investigators will use a drug that is typically used to treat endometriosis or uterine fibroids to reduce estrogen and FSH levels and an estrogen patch to increase estrogen in some women. The study will generate new knowledge on how menopause affects fat gain and disease risk.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Postmenopausal: GnRH antagonist + estradiol | Experimental | Drug: GnRH antagonist, Drug: Estrogen ProductGnRH antagonist is degarelix acetate, 80 mg, delivered twice as a subcutaneous injection (at baseline and after 12 weeks) Estradiol is a transdermal patch 0.075 mg, applied weekly for 24 weeks |
| Postmenopausal: GnRH antagonist + placebo | Experimental | Drug: GnRH antagonist, Drug: Placebo estradiolGnRH antagonist is degarelix acetate, 80 mg, delivered twice as a subcutaneous injection (at baseline and after 12 weeks) Placebo is a transdermal patch, applied weekly for 24 weeks |
| Postmenopausal: placebo + placebo | Placebo comparator | Drug: Placebo estradiol, Drug: Placebo GnRH antagonistPlacebo (1) is normal saline, delivered twice as a subcutaneous injection (at baseline and after 12 weeks) Placebo (2) is a transdermal patch, applied weekly for 24 weeks |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Volunteers will be healthy peri/postmenopausal women who are willing and able to undergo the proposed hormone manipulation and study procedures. Women will be at least 6 months but not more than 7 years past the last menstrual period (i.e., late perimenopausal or early postmenopausal) with FSH >30 IU/L. We will make a major effort to ensure that the women enrolled in this study come from all races and ethnicities and a wide range of socioeconomic and educational levels. Women will be excluded for the reasons listed below.
Key exclusion criteria (18 listed)
- abnormal vaginal bleeding
- on hormonal contraceptive or menopausal therapy or intention to start during the period of study
- positive pregnancy test or intention to become pregnant during the period of study
- lactation
- known hypersensitivity to degarelix acetate, estradiol, or medroxyprogesterone acetate
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 | Postmenopausal: GnRH antagonist + estradiol, Postmenopausal: GnRH antagonist + placebo |
| Estrogen ProductAlso: Estrogen transdermal patchEstrogen patches will be worn by those randomized to the Estradiol arms in both premenopausal and postmenopausal groups. Patches will be applied weekly and will be worn for the for entirety of the intervention (12 or 24 weeks). | Drug | Postmenopausal: GnRH antagonist + estradiol |
| Placebo estradiolAlso: Placebo transdermal patchPlacebo patches will be worn by those randomized to the placebo arms in both premenopausal and postmenopausal groups. Patches will be applied weekly and will be worn for the for entirety of the intervention (12 or 24 weeks). | Drug | Postmenopausal: GnRH antagonist + placebo, Postmenopausal: placebo + placebo |
| Placebo GnRH antagonistAlso: Placebo injectionPostmenopausal women randomized to the placebo injection arm will receive two placebo drug injections of normal saline (24-week intervention) | Drug | Postmenopausal: placebo + placebo |
Primary outcome
Change in the Microdialysis Cortisone Challenge (MCC) Index
Time frame: Baseline, week 12
The MCC Index is an in vivo measurement of local cortisol production in abdominal adipose tissue. A higher MCC Index is an indicator of more local cortisol production.
Change in the Oral Cortisone Challenge (OCC) Area Under the Curve (AUC)
Time frame: Baseline, week 12
The OCC AUC is a systemic measurement of peripheral glucocorticoid metabolism. A higher OCC AUC is an indicator of more production of cortisol.
5 secondary outcomes
Change in lumbar spine Bone Mineral Density (BMD)
Time frame: Baseline, week 24
Change in resting energy expenditure (REE)
Time frame: Baseline, week 12, week 24
Change in visceral fat area (VFA)
Time frame: Baseline, week 24
Change in flow-mediated dilation (FMD)
Time frame: Baseline, week 12, week 24
Change in proximal femur Bone Mineral Density (BMD)
Time frame: Baseline, week 24
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 18 Dec 2023.
- 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.
Wendy M Kohrt, PhD principal investigator
University of Colorado, Denver
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 and Estrogen Product in people with Menopause and Obesity, Abdominal, 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 1 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: looking for participants now, as of the sponsor's last update on 18 Dec 2023. 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. 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.
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?
Contact Haley Thomas (303-724-1407, haley.thomas@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Microdialysis Cortisone Challenge (MCC) Index (time frame: Baseline, week 12). The study lists 2 primary outcomes in all. 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 18 Dec 2023.