Treatment for Hot Flashes

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
MHAT Avis Medika, Pleven, Bulgaria
Hot Flashes+1 More
Eligibility
18+
Female
Eligible conditions
Select

Study Summary

This study is evaluating whether a treatment for hot flashes works better than a placebo.

See full description

Eligible Conditions

  • Hot Flashes
  • Vasomotor Symptoms Associated With Menopause

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

This trial is evaluating whether Treatment will improve 1 primary outcome and 2 secondary outcomes in patients with Hot Flashes. Measurement will happen over the course of Baseline to Week 12.

Baseline to Week 12
Mean change in frequency of moderate to severe hot flashes (HFs) from baseline to Week 12 (assessed by hot flash daily diary [HFDD])
Baseline to Week 56
Mean change in menopause specific quality of life scale (MENQOL) total score over time
Mean change in patient-reported outcomes measurement information system sleep disturbance short form 8b (PROMIS SD SF 8b) total score over time.

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Elinzanetant (BAY3427080)
1 of 2
Placebo
1 of 2
Active Control
Non-Treatment Group

This trial requires 600 total participants across 2 different treatment groups

This trial involves 2 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 3 and have had some early promising results.

Elinzanetant (BAY3427080)
Drug
Participants will receive 120 mg elinzanetant orally once daily.
Placebo
Drug
Participants will receive matching placebo orally once daily.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to week 56
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline to week 56 for reporting.

Closest Location

Physician Care Clinical Research - Sarasota, FL

Eligibility Criteria

This trial is for female patients aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
at least 12 months of spontaneous amenorrhea prior to signing of informed consent, or at least 6 months of spontaneous amenorrhea prior to signing of informed consent with serum follicle-stimulating hormone (FSH) levels > 40 mIU/mL and a serum estradiol concentration of < 30 pg/mL, or at least 6 months after hysterectomy at signing of informed consent with serum FSH levels > 40 mIU/mL and a serum estradiol concentration of < 30 pg/mL, or surgical bilateral oophorectomy with or without hysterectomy at least 6 weeks prior to signing of informed consent.
Moderate to severe hot flash (HF) associated with the menopause and seeking treatment for this condition.
Participant has completed Hot Flash Daily Diary (HFDD) for at least 11 days during the two weeks preceding baseline visit and is showing eligibility with respect to previous inclusion criterion during this time period.

Patient Q&A Section

What are common treatments for vasomotor symptoms associated with menopause?

"The treatments of moderate or severe vasomotor symptoms include estrogen/progestin-based combined oral contraceptives, estrogens, combined hormone therapy, vaginal estrogen, progestins, or progestogen implants. The combination of oral contraceptives with a progestogen implant has also become available in Europe since the introduction of the Mona Lisa study. Nonestrogen treatment options, including NSAFDs, antiprogestogens, aromatase inhibitors, selective serotonin reuptake inhibitors, and tricyclic antidepressant therapy, are commonly prescribed to moderately severe cases. For severe cases, antidepressants, combined oral contraceptives, vaginal estrogen, or a progestogen implant may be pursued as a next intervention." - Anonymous Online Contributor

Unverified Answer

What is vasomotor symptoms associated with menopause?

"In this multiethnic population of postmenopausal women, vasomotor symptoms were common, but more common among Hispanics than African Americans. Most women with vasomotor symptoms reported they weren't aware of them, and very few reported they were bothered by them." - Anonymous Online Contributor

Unverified Answer

What causes vasomotor symptoms associated with menopause?

"The causes of vasomotor symptoms associated with menopause are not clear. A vasomotor trigger could possibly be a factor that is causing discomfort, but it has not yet been demonstrated that it is the cause of these symptoms." - Anonymous Online Contributor

Unverified Answer

What are the signs of vasomotor symptoms associated with menopause?

"The frequency and severity of vasomotor symptoms during menopause can be significantly reduced by taking adequate amounts of estrogen. In addition, estrogen therapy also significantly ameliorates menopause-associated dyslipidemia and ameliorates the dyslipidemia even after menopause." - Anonymous Online Contributor

Unverified Answer

Can vasomotor symptoms associated with menopause be cured?

"Menopause-related VSM-related health-risk behaviors could not be completely interrupted, which can't be completely fixed in this case. Further research is necessary on treatments for menopausal-related VSM." - Anonymous Online Contributor

Unverified Answer

How many people get vasomotor symptoms associated with menopause a year in the United States?

"[Prevalence of vasomotor symptoms associated with menopause]: Almost half of women will have vasomotor symptoms at some point in their life; of those, about half will be bothered by severe symptoms at some point in their life; and 5% will suffer a severe vasomotor symptom attack during their life." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of treatment?

"The common side effects of treatment for early stage breast cancer were predictable based on the clinical trial results, highlighting the importance of shared-decision making as part of the medical management of breast cancer women. The most common side effect was asthenia with or without nausea and/or fatigue, affecting about half of the women in the trials. The common side effects of treatment included: nausea, loss of appetite, vomiting, abdominal pain, numbness, tingling in fingers or toes, weight gain, decreased ability to think clearly, anxiety and depression in menopause. Patients should review the medical information that accompanies their prescription." - Anonymous Online Contributor

Unverified Answer

What does treatment usually treat?

"We can clarify the definition of "treatment" in patients with vasomotor symptoms and treat the definition. The clinical perspective can lead to an integrated approach with both pharmacotherapy, hormonal therapy and surgical treatment for vasomotor symptoms." - Anonymous Online Contributor

Unverified Answer

How serious can vasomotor symptoms associated with menopause be?

"Women with menopausal vasomotor symptoms should be advised that they are not alone and that many women will also have other symptoms, like sleep disturbances, vaginal atrophy, and osteoporosis." - Anonymous Online Contributor

Unverified Answer

Is treatment typically used in combination with any other treatments?

"Although most women treated for vasomotor symptoms used a combination of medication, less than 50% received a monotherapeutic hormone substitution (HRT or AAS). Results from a recent clinical trial confirm that women often use multiple treatments for vasomotor symptoms, including combination therapies." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of vasomotor symptoms associated with menopause?

"More than half of women with vasomotor symptoms as a result of menopause do not have a known cause. Further examinations are necessary to understand what causes what severity of vasomotor symptoms." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in treatment for therapeutic use?

"There are many advances in our understanding of vasomotor symptoms and ways to minimize them, and the number of potential treatment options are increasing rapidly. Because not all therapies for menopausal vasomotor symptoms are on the market, we may have to select the option that is easiest to use, is effective, and is well tolerated." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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