New pill could cool menopause hot flashes without hormones
NCT ID NCT06385795
First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time
Summary
This study tested an experimental drug called NOE-115 in 40 women aged 45 to 60 who have moderate to severe hot flashes due to menopause. The goal was to see if the drug is safe and can reduce symptoms. Participants took the drug for 4 weeks, and researchers tracked side effects and how well it worked.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- NOE-115
- What this could lead to
- If successful, this could point toward a new non-hormonal treatment option for hot flashes during menopause.
- What could go wrong
- This is a small, early-phase trial with only 40 women and no placebo group, so results may not be conclusive or apply to everyone. Side effects are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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40 people
The number who actually took part.
- Started
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Apr 2024
- Finished
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Aug 2025
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
45 to 60 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Capable of giving signed informed consent as described in study protocol which includes compliance with the requirements and restrictions listed in the Informed Consent Form. * Female 45 years to 60 years of age inclusive, at the time of signing the Informed Consent Form * Women who have experienced changes in menstrual cycle frequency or duration, and/or symptoms that are indicative of menopausal transition, as determined by the investigator * Greene climacteric scale (GCS) total score \> 20 and GCS subscore for VMS ≥ 3 * Over the 10 days prior to enrolment (during the Screening Period), subject has a minimum of 7 to 8 moderate to severe hot flashes (VMS) per day, or 50 to 60 per week * Body weight \> 50 kg; Body Mass Index (BMI) within the range 17.5 to 40.0 kg/m2 (inclusive) Exclusion Criteria: * Clinically overt alcohol or drug use disorder (including use of cannabis/cannabinoids within 4 weeks prior to Screening). * History of psychiatric diagnoses (schizophrenia, schizoaffective, obsessive-compulsive disorder, bipolar disorder, or Attention Deficit/hyperactivity Disorder(ADHD) * Current episode of major depression with Hamilton Rating Scale for Depression (HAM-D-17) score ≥ 17 \[to be calculated as a subscore of the Structured interview guide for the Hamilton depression scale with atypical depression supplement \[SIGH-ADS\] * Prior or current history of a malignant tumor, except for basal cell carcinoma in remission * Participants with a current history of significant cardiovascular, pulmonary, gastrointestinal, renal, hepatic, metabolic, hematological, immunological, or neurological disease that, in the opinion of the investigator or medical monitor, could compromise either the patient's safety or the results of the study * Participant has abnormal findings identified during the Screening Period assessments, including neurological and physical examinations, hematology and biochemistry parameters, pulse rate and/or blood pressure and electrocardiogram (ECG), as compared with the appropriate reference ranges; if judged not clinically significant, the PI should document this fact appropriately * History of unexplained uterine bleeding or endometrial hyperplasia * History of acute angle closure glaucoma * History of cardiovascular disease including: a) Uncontrolled hypertension (systolic Blood Pressure (BP) \> 165 mmHg or diastolic Blood Pressure \> 100 mmHg) b) History of myocardial infarction, cardiac arrhythmia (other than sinus arrhythmia) c) Patients with a 12-lead Electrocardiogram (ECG demonstrating either of the following: QT interval corrected for heart rate according to Fridericia's formula (QTcF) ≥ 470 msec (average of 3 Electrocardiograms (ECGs) obtained at the Screening Visit and assessed by central reader) QRS interval \> 120 msec at the Screening Visit (local reading) Arrhythmia (other than sinus arrhythmia), conduction abnormalities (Atrioventricular block Grade 1 is allowed) * Patients who express suicidal ideation or have recent history of suicidal behavior and who, in the opinion of the investigator, are at risk of harming themselves
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Noema PMM-201 Site #101
Atlanta, Georgia, 30030, United States
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Noema PMM-201 Site #102
Jacksonville, Florida, 32256, United States
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Noema PMM-201 Site #103
Seattle, Washington, 98105, United States
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Noema PMM-201 Site #104
San Diego, California, 92111, United States
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Noema PMM-201 Site #106
Las Vegas, Nevada, 89106, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Non-Hormonal pill targets hot flashes in menopause
- Two estradiol dosing schedules put brain effects to the test
- Can strength training steady the walk and strengthen the pelvic floor after menopause?
- Can a brazilian diet calm menopause hot flashes?
- Can Omega-3s keep menopausal minds sharp?
- Does hormone therapy for menopause leave a mark on breasts and arteries?