MenopausePhase 4NCT03047330
Menopausal Sleep Fragmentation and Body Fat Gain
A Phase 4 study testing Estradiol withdrawal and Fragmented sleep in people with Menopause, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
This study aims to investigate the impact of menopause-related sleep fragmentation on metabolic biomarkers of body fat gain. The investigators hypothesize that experimental sleep fragmentation will result in an adverse leptin response as a metabolic biomarker for body fat gain. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause
- What is being tested?
- Estradiol withdrawal and Fragmented sleep
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2017to 1 Aug 2022
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy premenopausal women 18-45 years old
- Regular sleep schedule
- Limited alcohol and caffeine intake
- Regular monthly menstrual cycles
- No lifetime history of hot flashes
- Willingness to use approved methods of contraception during study
- Not obese
- Good general health
Who cannot join
- Contraindication, hypersensitivity or previous adverse reaction to gonadotropin releasing hormone agonists
- Pregnancy
- Breastfeeding
- Tobacco use
- Contraindicated systemic hormone medications or centrally active medications
- Shift workers or recent/expected time zone travel
Show all 17Show fewer
- Obstructive sleep apnea
- Insomnia symptoms
- Diagnosis of osteoporosis or osteopenia
- Hypothalamic-pituitary-adrenal axis disorders
- Diabetes
- Gastric bypass, metabolic disorders, or other related conditions
- Abnormalities on screening laboratory tests
- Substantial hearing impairment
- Cardiovascular illness
- Neurological illness
- Recent psychiatric illness or substance-use disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham & Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Menopausal Sleep Fragmentation: Impact on Body Fat Gain Biomarkers in Women
This study aims to investigate the impact of menopause-related sleep fragmentation on metabolic biomarkers of body fat gain. The investigators hypothesize that experimental sleep fragmentation will result in an adverse leptin response as a metabolic biomarker for body fat gain.
Read the detailed description
While obesity is highly prevalent in midlife and older women, with rates increasing markedly after age 40 and body fat increasing in half of women during and after the menopause transition, factors causing these changes are not well understood. Reduced total sleep time has been shown to adversely impact biomarkers of obesity, but the effect of the highly prevalent menopause-related sleep fragmentation secondary to hot flashes on metabolism and eating behaviors in humans is not known. We will use experimental paradigms to isolate the impact of menopause-related sleep disruption, as well as that of hot flashes and estrogen withdrawal, metabolic biomarkers of body fat gain and on eating behaviors, results of which will inform strategies to prevent body fat gain and improve cardio-metabolic health outcomes in women.
- Conditions
- Menopause
- Being tested
- Estradiol withdrawal, Fragmented sleep
- Keywords
- menopause, sleep fragmentation, leuprolide, adipokine, weight gain, leptin
- Medical subject headings
- Sleep Deprivation, Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Estradiol withdrawalDrug
Also called Leuprolide Acetate; Lupron
one injection of open-label intramuscular dose of leuprolide (3.75-mg depot), a gonadotropin-releasing hormone agonist that rapidly suppresses estradiol and temporarily achieves ovarian suppression.
Fragmented sleepOther
Fragmented sleep will be experimentally induced.
| Study group | Role | What they receive |
|---|---|---|
| Study arm | Experimental | Participants completed 2 nights of unfragmented sleep followed by 3 nights of experimentally-fragmented sleep during high estradiol (E2) phase of their menstrual cycle (Sleep Block 1). A subset of participants repeated these procedures in an experimentally-induced low-E2 state (Sleep Block 2). Receives: Drug: Estradiol withdrawal; Other: Fragmented sleep |
What is being measured
The primary outcome is the main question the study is designed to answer.
Normalized Serum Leptin Levels
12-hr overnight fasted AM (morning) blood samples were assayed for leptin levels on study days 2-6 under both estrogenized and estradiol-withdrawal conditions [total: 10 samples]. For each individual, leptin values were normalized relative to the mean baseline leptin value. Baseline was defined as the unfragmented estrogenized condition (avg. of study days 2-3 in the estrogenized condition).
Measured: pre/post sleep fragmentation (3 days); pre/post estradiol withdrawal (~5 weeks)
Secondary outcomes (1)
Normalized Satiety Scores
12-hr overnight fasted AM satiety scores were collected on study days 2-6 under both estrogenized and estradiol-withdrawal conditions [total: 10 scores]. For each individual, satiety scores were normalized relative to the mean baseline satiety score. Baseline was defined as the unfragmented estrogenized condition (avg. of study days 2-3 in the estrogenized condition).
Measured: pre/post sleep fragmentation (3 days); pre/post estradiol withdrawal (~5 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2017 (estimated)
- Study start15 Jul 2017
- Primary completion1 Aug 2022
- Study completion1 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for MenopauseStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Hadine Joffe, MD MSc, Brigham and Women's Hospital
- Investigators
- Hadine Joffe, MD MSc, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03047330
- Sponsor's protocol ID
- 2016P002821
- Other IDs
- 1R01AG053838
- Status last verified
- Sep 2024
- First submitted
- 7 Feb 2017
- Last updated
- 8 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Menopausal Sleep Fragmentation: Impact on Body Fat Gain Biomarkers in Women
- ClinicalTrials.gov ID
- NCT03047330
- Acronym / sponsor ID
- 2016P002821
- Conditions
- Menopause
- Keywords
- menopause, sleep fragmentation, leuprolide, adipokine, weight gain, leptin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 15 Jul 2017 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 8 Feb 2017 (estimated)
- Results
- Posted 8 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to investigate the impact of menopause-related sleep fragmentation on metabolic biomarkers of body fat gain. The investigators hypothesize that experimental sleep fragmentation will result in an adverse leptin response as a metabolic biomarker for body fat gain.
Detailed description
While obesity is highly prevalent in midlife and older women, with rates increasing markedly after age 40 and body fat increasing in half of women during and after the menopause transition, factors causing these changes are not well understood. Reduced total sleep time has been shown to adversely impact biomarkers of obesity, but the effect of the highly prevalent menopause-related sleep fragmentation secondary to hot flashes on metabolism and eating behaviors in humans is not known. We will use experimental paradigms to isolate the impact of menopause-related sleep disruption, as well as that of hot flashes and estrogen withdrawal, metabolic biomarkers of body fat gain and on eating behaviors, results of which will inform strategies to prevent body fat gain and improve cardio-metabolic health outcomes in women.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study arm | Experimental | Drug: Estradiol withdrawal, Other: Fragmented sleepParticipants completed 2 nights of unfragmented sleep followed by 3 nights of experimentally-fragmented sleep during high estradiol (E2) phase of their menstrual cycle (Sleep Block 1). A subset of participants repeated these procedures in an experimentally-induced low-E2 state (Sleep Block 2). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Healthy premenopausal women 18-45 years old
- Regular sleep schedule
- Limited alcohol and caffeine intake
- Regular monthly menstrual cycles
- No lifetime history of hot flashes
Key exclusion criteria (17 listed)
- Contraindication, hypersensitivity or previous adverse reaction to gonadotropin releasing hormone agonists
- Pregnancy
- Breastfeeding
- Tobacco use
- Contraindicated systemic hormone medications or centrally active 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 |
|---|---|---|
| Estradiol withdrawalAlso: Leuprolide Acetate; Lupronone injection of open-label intramuscular dose of leuprolide (3.75-mg depot), a gonadotropin-releasing hormone agonist that rapidly suppresses estradiol and temporarily achieves ovarian suppression. | Drug | Study arm |
| Fragmented sleepFragmented sleep will be experimentally induced. | Other | Study arm |
Primary outcome
Normalized Serum Leptin Levels
Time frame: pre/post sleep fragmentation (3 days); pre/post estradiol withdrawal (~5 weeks)
12-hr overnight fasted AM (morning) blood samples were assayed for leptin levels on study days 2-6 under both estrogenized and estradiol-withdrawal conditions [total: 10 samples]. For each individual, leptin values were normalized relative to the mean baseline leptin value. Baseline was defined as the unfragmented estrogenized condition (avg. of study days 2-3 in the estrogenized condition).
1 secondary outcome
Normalized Satiety Scores
Time frame: pre/post sleep fragmentation (3 days); pre/post estradiol withdrawal (~5 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Hadine Joffe, MD MSc principal investigator
Brigham and Women's Hospital
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 Estradiol withdrawal and Fragmented sleep in people with Menopause, run by Brigham and Women's Hospital 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 8 inclusion and 17 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 8 Oct 2024. 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?
Yes. Results are posted in the registry (first posted 8 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Normalized Serum Leptin Levels (time frame: pre/post sleep fragmentation (3 days); pre/post estradiol withdrawal (~5 weeks)). 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 8 Oct 2024; AzTrials last refreshed its copy on 1 Nov 2026.