MenopausePhase 4NCT01116401
Impact of Hot Flashes on Sleep and Mood Disturbance
A Phase 4 study testing leuprolide in people with Menopause and Depression, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
We plan to enroll premenopausal women in a trial investigating the impact of hot flashes developed in response to an injection of a gonadotropin-releasing hormone agonist (GnRHa), leuprolide (brand name: Lupron), on sleep disruption and mood. This study is designed to mimic the menopause transition. 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, Depression, Hot Flashes
- What is being tested?
- leuprolide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Nov 2009to 4 Jan 2012
- 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
- Women 18-45 years old
- Premenopausal
- Willingness to use barrier methods of contraception during study and after completion of study until menses resume
- Good general health
Who cannot join
- Pregnancy or currently breastfeeding
- Hot flushes
- Mid-luteal phase progesterone <3ng/mL
- Clinically significant abnormalities in screening blood tests
- BMI > 35 kg/m2
- Previously diagnosed osteoporosis or osteopenia
Show all 16Show fewer
- Clinically significant depressive symptoms
- Psychiatric illness
- Sleep apnea or periodic limb movement of sleep (PLMS)
- Contraindication, hypersensitivity, or previous allergic reaction to GnRH agonists
- Current or recent use of centrally active medications
- Current or recent use of systemic hormone medications
- Night shift workers
- Current use of over-the-counter (OTC) medications that may affect hot flashes, sleep, or mood
- Abnormal vaginal bleeding
- History of any medical diseases that may put subject at risk when treated with study medication.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Impact of Experimentally Induced Hot Flashes on Sleep and Mood Disturbance
We plan to enroll premenopausal women in a trial investigating the impact of hot flashes developed in response to an injection of a gonadotropin-releasing hormone agonist (GnRHa), leuprolide (brand name: Lupron), on sleep disruption and mood. This study is designed to mimic the menopause transition. We will collect data on sleep disruption and mood changes to assess their relationship to the development of hot flashes.
- Conditions
- Menopause, Depression, Hot Flashes
- Being tested
- leuprolide
- Keywords
- Hot Flashes, Sleep disturbance, Lupron, Menopause
- Medical subject headings
- Depression, Hot Flashes, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
leuprolideDrug
Also called Lupron
Leuprolide acetate is a widely used GnRH agonist. In this protocol, leuprolide will be administered at a dose routinely used for treatment of endometriosis and uterine fibroids in women (one 3.75-mg intramuscular injection).
| Study group | Role | What they receive |
|---|---|---|
| GnRH Agonist Injection | Experimental | We will be administering an injection of leuprolide acetate (a GnRH agonist) to all participants. Receives: Drug: leuprolide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in Wake After Sleep Onset (WASO)
Wake after sleep onset (WASO) is calculated by averaging the number of minutes spent awake after initiating sleep each night from the two ambulatory polysomnography studies conducted at baseline and the two ambulatory polysomnography studies conducted four weeks after the GnRHa injection.
Measured: baseline and 4 weeks
Secondary outcomes (1)
Change in Montgomery-Asperg Depression Rating Scale (MADRS)
The Montgomery-Åsberg Depression Rating Scale is a widely used 10-item clinician-rated scale that describes the severity of depressive symptoms. It has a range of 0-60 with higher scores indicating greater symptom burden. Participants were assessed at baseline and four weeks after the GnRHa injection in order to calculate the change in MADRS score.
Measured: baseline and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2010 (estimated)
- Study start3 Nov 2009
- Primary completion29 Dec 2011
- Study completion4 Jan 2012
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.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for MenopauseStudies of the same condition, open and under way.
- More trials run by Massachusetts General 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
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Hadine Joffe, MD, Brigham and Women's Hospital
- Investigators
- Hadine Joffe, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01116401
- Sponsor's protocol ID
- 2009-P-001557
- Other IDs
- 5R01MH082922
- Status last verified
- Dec 2017
- First submitted
- 3 May 2010
- Last updated
- 23 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Joffe H, Crawford SL, Freeman MP, White DP, Bianchi MT, Kim S, Economou N, Camuso J, Hall JE, Cohen LS. Independent Contributions of Nocturnal Hot Flashes and Sleep Disturbance to Depression in Estrogen-Deprived Women. J Clin Endocrinol Metab. 2016 Oct;101(10):3847-3855. doi: 10.1210/jc.2016-2348. Epub 2016 Sep 28.
PubMed 27680875Bianchi MT, Kim S, Galvan T, White DP, Joffe H. Nocturnal Hot Flashes: Relationship to Objective Awakenings and Sleep Stage Transitions. J Clin Sleep Med. 2016 Jul 15;12(7):1003-9. doi: 10.5664/jcsm.5936.
PubMed 26951410Joffe H, Crawford S, Economou N, Kim S, Regan S, Hall JE, White D. A gonadotropin-releasing hormone agonist model demonstrates that nocturnal hot flashes interrupt objective sleep. Sleep. 2013 Dec 1;36(12):1977-85. doi: 10.5665/sleep.3244.
PubMed 24293774
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Experimentally Induced Hot Flashes on Sleep and Mood Disturbance
- ClinicalTrials.gov ID
- NCT01116401
- Acronym / sponsor ID
- 2009-P-001557
- Conditions
- Menopause, Depression, Hot Flashes
- Keywords
- Hot Flashes, Sleep disturbance, Lupron, Menopause
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 3 Nov 2009 (actual)
- Primary completion
- 29 Dec 2011 (actual)
- Study completion
- 4 Jan 2012 (actual)
- First posted
- 5 May 2010 (estimated)
- Results
- Posted 26 Dec 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We plan to enroll premenopausal women in a trial investigating the impact of hot flashes developed in response to an injection of a gonadotropin-releasing hormone agonist (GnRHa), leuprolide (brand name: Lupron), on sleep disruption and mood. This study is designed to mimic the menopause transition. We will collect data on sleep disruption and mood changes to assess their relationship to the development of hot flashes.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GnRH Agonist Injection | Experimental | Drug: leuprolideWe will be administering an injection of leuprolide acetate (a GnRH agonist) to all participants. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women 18-45 years old
- Premenopausal
- Willingness to use barrier methods of contraception during study and after completion of study until menses resume
- Good general health
Key exclusion criteria (16 listed)
- Pregnancy or currently breastfeeding
- Hot flushes
- Mid-luteal phase progesterone <3ng/mL
- Clinically significant abnormalities in screening blood tests
- BMI > 35 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 |
|---|---|---|
| leuprolideAlso: LupronLeuprolide acetate is a widely used GnRH agonist. In this protocol, leuprolide will be administered at a dose routinely used for treatment of endometriosis and uterine fibroids in women (one 3.75-mg intramuscular injection). | Drug | GnRH Agonist Injection |
Primary outcome
Percent Change in Wake After Sleep Onset (WASO)
Time frame: baseline and 4 weeks
Wake after sleep onset (WASO) is calculated by averaging the number of minutes spent awake after initiating sleep each night from the two ambulatory polysomnography studies conducted at baseline and the two ambulatory polysomnography studies conducted four weeks after the GnRHa injection.
1 secondary outcome
Change in Montgomery-Asperg Depression Rating Scale (MADRS)
Time frame: baseline and 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27680875Joffe H, Crawford SL, Freeman MP, White DP, Bianchi MT, Kim S, Economou N, Camuso J, Hall JE, Cohen LS. Independent Contributions of Nocturnal Hot Flashes and Sleep Disturbance to Depression in Estrogen-Deprived Women. J Clin Endocrinol Metab. 2016 Oct;101(10):3847-3855. doi: 10.1210/jc.2016-2348. Epub 2016 Sep 28.
- Derived from this study: PubMed 26951410Bianchi MT, Kim S, Galvan T, White DP, Joffe H. Nocturnal Hot Flashes: Relationship to Objective Awakenings and Sleep Stage Transitions. J Clin Sleep Med. 2016 Jul 15;12(7):1003-9. doi: 10.5664/jcsm.5936.
- Derived from this study: PubMed 24293774Joffe H, Crawford S, Economou N, Kim S, Regan S, Hall JE, White D. A gonadotropin-releasing hormone agonist model demonstrates that nocturnal hot flashes interrupt objective sleep. Sleep. 2013 Dec 1;36(12):1977-85. doi: 10.5665/sleep.3244.
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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 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 leuprolide in people with Menopause and Depression, run by Massachusetts General 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 4 inclusion and 16 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 23 Jan 2018. 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 26 Dec 2017). 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?
Percent Change in Wake After Sleep Onset (WASO) (time frame: baseline and 4 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 NCT01116401, which also lists 3 linked publications.
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 23 Jan 2018.