Hot FlashesPhase 4NCT00455689
Understanding Experimentally Induced Hot Flushes
A Phase 4 study testing Leuprolide acetate in people with Hot Flashes, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The purpose of the study is to examine the impact of hot flushes on sleep, mood, and well-being. The investigators will cause hot flushes by giving study participants the hormone medication, leuprolide (Lupron), which is a manufactured (artificial) hormone that makes the body think that it has reached menopause… 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
- Hot Flashes
- What is being tested?
- Leuprolide acetate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Nov 2005to 2 Sep 2007
- 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
- Breastfeeding
- Hot flushes
- Hemoglobin at the screening visit less than 10 gm/dL
- Abnormal liver function tests
- Abnormal renal function tests
Show all 25Show fewer
- BMI > 35 kg/m2
- Previously diagnosed osteoporosis or osteopenia
- Psychiatric disorder involving mood, anxiety, psychotic disorder, current anorexia nervosa, or current alcohol or substance-use disorder
- Previous severe depression
- Evidence of suicidal or homicidal ideation
- Sleep apnea, narcolepsy, or other diagnosed sleep disorder
- Contraindication, hypersensitivity, or previous allergic reaction to GnRH agonists
- Regular use of centrally active medications
- Use of hormonal medications for at least 2 months
- Use of ketoconazole, clomiphene citrate, or anabolic/androgenic steroids in the preceding 3 months
- Renal insufficiency
- Abnormal vaginal bleeding
- History of thrombo-embolism or cardiovascular disease
- History of congestive heart failure or other conditions requiring sodium restriction
- History of spinal cord compression
- Metastatic vertebral lesions
- Memory disorders
- Urinary tract obstruction
- History of liver, kidney, pulmonary, or metabolic disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Understanding Experimentally Induced Hot Flushes and Their Impact on Sleep and Mood
The purpose of the study is to examine the impact of hot flushes on sleep, mood, and well-being. The investigators will cause hot flushes by giving study participants the hormone medication, leuprolide (Lupron), which is a manufactured (artificial) hormone that makes the body think that it has reached menopause temporarily. Most women begin to have hot flushes within 4 weeks after taking leuprolide and resume menses 3 months later. The investigators will administer questionnaires to evaluate changes in sleep and mood over the course of the study.
- Conditions
- Hot Flashes
- Being tested
- Leuprolide acetate
- Keywords
- Lupron, Premenopausal, Hot flashes
- Medical subject headings
- Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leuprolide acetateDrug
Also called Lupron
Leuprolide acetate (Lupron Depot®) 3.75-mg intramuscular injection
Leuprolide is a widely used gonadotropin-releasing hormone agonist (GnRHa) that is indicated for treatment of endometriosis, uterine fibroids, precocious puberty, and prostate cancer, and is used off-label for in-vitro fertilization and premenstrual syndrome. In this protocol, leuprolide will be administered once during the mid-luteal phase of the menstrual cycle at a dose routinely used for treatment of endometriosis and uterine fibroids in women.
| Study group | Role | What they receive |
|---|---|---|
| Developed hot flashes | Experimental | Subjects who developed hot flashes after receiving leuprolide acetate (3.75 mg intramuscular injection) Receives: Drug: Leuprolide acetate |
| Did not develop hot flashes | Experimental | Subjects who did not develop hot flashes after receiving leuprolide acetate (3.75 mg intramuscular injection) Receives: Drug: Leuprolide acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in Objective Sleep Efficiency
Objective sleep efficiency was measured using actigraphy. Sleep efficiency (percent of time spent asleep between bedtime and wake time) was calculated and averaged over 2 consecutive nights both before and 4 weeks after receiving the intervention.
Measured: baseline (before receiving intervention) and 4 weeks after receiving intervention
Secondary outcomes (1)
Change in Subjective Sleep Quality
Sleep quality was measured using the Pittsburgh Sleep Quality Index (PSQI; range 0-21, higher score indicates poorer quality sleep), which was administered both before and four weeks after receiving the intervention.
Measured: baseline (before receiving intervention) and 4 weeks after receiving intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2007 (estimated)
- Study start28 Nov 2005
- Primary completion24 Jul 2007
- Study completion2 Sep 2007
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 (1)Papers the sponsor has linked to this study.
- Other trials for Hot FlashesStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Endocrine Research Society
- Responsible party
- Principal investigator, Hadine Joffe, MD, Brigham and Women's Hospital
- Investigators
- Hadine Joffe, M.D., M.Sc., Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00455689
- Sponsor's protocol ID
- 2005P-001512
- Status last verified
- Aug 2018
- First submitted
- 2 Apr 2007
- Last updated
- 18 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Joffe H, Deckersbach T, Lin NU, Makris N, Skaar TC, Rauch SL, Dougherty DD, Hall JE. Metabolic activity in the insular cortex and hypothalamus predicts hot flashes: an FDG-PET study. J Clin Endocrinol Metab. 2012 Sep;97(9):3207-15. doi: 10.1210/jc.2012-1413. Epub 2012 Jun 20.
PubMed 22723326
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Experimentally Induced Hot Flushes and Their Impact on Sleep and Mood
- ClinicalTrials.gov ID
- NCT00455689
- Acronym / sponsor ID
- 2005P-001512
- Conditions
- Hot Flashes
- Keywords
- Lupron, Premenopausal, Hot flashes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Endocrine Research Society
- Study start
- 28 Nov 2005 (actual)
- Primary completion
- 24 Jul 2007 (actual)
- Study completion
- 2 Sep 2007 (actual)
- First posted
- 4 Apr 2007 (estimated)
- Results
- Posted 21 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to examine the impact of hot flushes on sleep, mood, and well-being. The investigators will cause hot flushes by giving study participants the hormone medication, leuprolide (Lupron), which is a manufactured (artificial) hormone that makes the body think that it has reached menopause temporarily. Most women begin to have hot flushes within 4 weeks after taking leuprolide and resume menses 3 months later. The investigators will administer questionnaires to evaluate changes in sleep and mood over the course of the study.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Developed hot flashes | Experimental | Drug: Leuprolide acetateSubjects who developed hot flashes after receiving leuprolide acetate (3.75 mg intramuscular injection) |
| Did not develop hot flashes | Experimental | Drug: Leuprolide acetateSubjects who did not develop hot flashes after receiving leuprolide acetate (3.75 mg intramuscular injection) |
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 (25 listed)
- Pregnancy
- Breastfeeding
- Hot flushes
- Hemoglobin at the screening visit less than 10 gm/dL
- Abnormal liver function tests
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 |
|---|---|---|
| Leuprolide acetateAlso: LupronLeuprolide acetate (Lupron Depot®) 3.75-mg intramuscular injection Leuprolide is a widely used gonadotropin-releasing hormone agonist (GnRHa) that is indicated for treatment of endometriosis, uterine fibroids, precocious puberty, and prostate cancer, and is used off-label for in-vitro fertilization and premenstrual syndrome. In this protocol, leuprolide will be administered once during the mid-luteal phase of the menstrual cycle at a dose routinely used for treatment of endometriosis and uterine fibroids in women. | Drug | Developed hot flashes, Did not develop hot flashes |
Primary outcome
Percent Change in Objective Sleep Efficiency
Time frame: baseline (before receiving intervention) and 4 weeks after receiving intervention
Objective sleep efficiency was measured using actigraphy. Sleep efficiency (percent of time spent asleep between bedtime and wake time) was calculated and averaged over 2 consecutive nights both before and 4 weeks after receiving the intervention.
1 secondary outcome
Change in Subjective Sleep Quality
Time frame: baseline (before receiving intervention) and 4 weeks after receiving intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22723326Joffe H, Deckersbach T, Lin NU, Makris N, Skaar TC, Rauch SL, Dougherty DD, Hall JE. Metabolic activity in the insular cortex and hypothalamus predicts hot flashes: an FDG-PET study. J Clin Endocrinol Metab. 2012 Sep;97(9):3207-15. doi: 10.1210/jc.2012-1413. Epub 2012 Jun 20.
Related trials for Hot Flashes
Active, not recruitingObservational study
Lemborexant vs Clonidine vs Sedatives to Treat Insomnia in Chronic Pain Patients
Chronic Insomnia, Chronic Pain
Active, not recruitingPhase 2
Phase IIB Trial of Bazedoxifene Plus Conjugated Estrogens
Risk Reduction, Breast Cancer
Active, not recruitingPhase 3
A Study to Confirm if Fezolinetant Helps Reduce Hot Flashes in Women With Breast Cancer Who Are Having Hormone Therapy
Hot Flashes
Not yet recruiting
Internet-Delivered CBT Program for Menopausal Vasomotor Symptoms
Menopause, Menopausal Vasomotor Symptoms
Not yet recruiting
Self-Management Box on Hot Flash in Postmenopausal Women
Postmenopausal Flushing, Postmenopausal Symptoms
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, M.D., M.Sc. 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 acetate in people with Hot Flashes, 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 25 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 18 Sep 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 21 Aug 2018). 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 Objective Sleep Efficiency (time frame: baseline (before receiving intervention) and 4 weeks after receiving intervention). 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 NCT00455689, which also lists 1 linked publication.
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 Sep 2018; AzTrials last refreshed its copy on 29 Oct 2026.