NOE-115 for Hot Flashes Due to Menopause

No longer recruiting at 4 trial locations

Overseen By Noema Pharma Clinical

Age: 18 - 65

Sex: Female

Trial Phase: Phase 2

Sponsor: Noema Pharma AG

Must not be taking: Cannabis, others

Disqualifiers: Alcohol use disorder, Major depression, Malignant tumor, Cardiovascular disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and effectiveness of a new treatment called NOE-115 for reducing moderate to severe hot flashes in women experiencing menopause. Researchers seek to determine if this experimental treatment can manage these uncomfortable symptoms. Women who experience frequent hot flashes—about 7 to 8 per day or 50 to 60 per week—and have noticed changes in their menstrual cycles might be suitable candidates for this trial. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is there any evidence suggesting that NOE-115 is likely to be safe for humans?

Research has shown that NOE-115 is safe and well-tolerated in studies with healthy volunteers. Participants did not experience serious side effects, and no one needed to stop the treatment due to adverse reactions. This suggests that NOE-115 might be safe for treating hot flashes in women undergoing menopause. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for hot flashes due to menopause, which often include hormone replacement therapy and certain antidepressants, NOE-115 is unique because it involves escalating doses of a new compound. Researchers are excited about NOE-115 because it potentially offers an alternative mechanism of action, which may provide relief without the hormone-related side effects linked to traditional options. This novel approach could represent a significant advancement for those seeking non-hormonal treatment alternatives for menopause symptoms.

What evidence suggests that NOE-115 might be an effective treatment for hot flashes?

Research has shown that NOE-115, the investigational treatment in this trial, may help reduce moderate to severe hot flashes in women going through menopause. One study found that participants experienced an average reduction of 92.3% in the number of daily hot flashes over 12 weeks. This suggests that NOE-115 could greatly ease the discomfort caused by these symptoms. Additionally, NOE-115 might assist with other menopause-related issues, such as weight gain and daytime fatigue. These findings indicate that NOE-115 has the potential to improve the quality of life for women dealing with menopausal symptoms. ^{1 2 3 6 7}

Who Is on the Research Team?

Clinical Director, MD

Principal Investigator

Noema Pharma AG

Are You a Good Fit for This Trial?

This trial is for women aged 45-60 who are experiencing moderate to severe hot flashes due to menopause. Participants must have had at least 7-8 daily hot flashes or 50-60 weekly, weigh over 50 kg with a BMI of 17.5-40, and be able to consent to the study's requirements.

Inclusion Criteria

Greene climacteric scale (GCS) total score > 20 and GCS subscore for VMS ≥ 3

I've had 7-8 severe hot flashes daily or 50-60 weekly for the last 10 days.

I can sign and follow the study's consent form.

Exclusion Criteria

I have had acute angle closure glaucoma.

I have had unexplained bleeding or thickening of my uterus lining.

Clinically overt alcohol or drug use disorder (including use of cannabis/cannabinoids within 4 weeks prior to Screening)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Treatment

Participants receive NOE-115 daily for 4 weeks to assess safety, tolerability, and preliminary efficacy on vasomotor symptoms

4 weeks

Multiple visits for tolerability assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• NOE-115

Trial Overview The study is testing NOE-115's safety, tolerability, and initial effectiveness in reducing menopausal vasomotor symptoms (hot flashes). Women will receive NOE-115 and their response to treatment will be monitored.

How Is the Trial Designed?

Group I: NOE-115 Experimental Treatment 1 Intervention

Escalating doses of NOE-115 capsules

Who Is Running the Clinical Trial?

Noema Pharma AG

Lead Sponsor

Trials

6

Recruited

570+

Published Research Related to This Trial

About 69% of postmenopausal women experiencing moderate to severe hot flashes indicated that they would consider a nonhormonal treatment effective if it reduced the frequency of hot flashes by at least 50%.

The study established that a 50% reduction in hot flashes is the minimal clinically important difference, which can help in designing clinical trials for new treatments targeting hot flashes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Minimal decrease in hot flashes desired by postmenopausal women in family practice. Butt, DA., Deng, LY., Lewis, JE., et al.[2007]

A systematic review of nine studies involving postmenopausal women found that low-dose transdermal estrogen significantly reduces the daily number of moderate to severe hot flashes compared to placebo, with a mean decrease of 9.36 hot flashes for the highest dose range.

All doses of low-dose transdermal estrogen were effective, and the results were statistically significant (P < 0.05), indicating that this treatment is a viable option for managing hot flashes in postmenopausal women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-dose transdermal estradiol for vasomotor symptoms: a systematic review. Corbelli, J., Shaikh, N., Wessel, C., et al.[2018]

Out of 51 well-designed randomized controlled trials (RCTs) identified from a review of 3548 studies, gabapentin consistently showed significant benefits over placebo for treating hot flashes, making it a leading non-hormonal option.

While other compounds like desvenlafaxine, soy-derived isoflavones, and black cohosh also showed some efficacy, only gabapentin demonstrated consistent results across all trials, and safety concerns were noted for desvenlafaxine, including cardiovascular risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effective and clinically meaningful non-hormonal hot flash therapies. Guttuso, T.[2023]

In a meta-analysis of 12 trials involving 1467 breast cancer survivors, non-hormonal drugs (NHD) like venlafaxine and gabapentin were associated with a higher frequency of adverse effects (AE), with 81% of reported AEs occurring in the treatment group.

The severity of AEs was mostly mild (67%), but increased doses of venlafaxine and gabapentin led to more significant AEs compared to placebo, suggesting careful consideration of dosage when using these treatments for hot flashes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse effects of non-hormonal pharmacological interventions in breast cancer survivors, suffering from hot flashes: A systematic review and meta-analysis. Hervik, JB., Stub, T.[2018]

In a study of 71 postmenopausal breast cancer patients, both depot medroxyprogesterone acetate (MPA) and oral megestrol acetate significantly reduced hot flashes by an average of 86% over 6 weeks, with no significant difference in effectiveness between the two treatments.

However, the long-term maintenance of relief was notably better with depot MPA, as 89% of responders maintained their improvement at week 24 compared to only 45% in the megestrol group, suggesting that MPA may be a more effective option for sustained relief.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intramuscular depot medroxyprogesterone versus oral megestrol for the control of postmenopausal hot flashes in breast cancer patients: a randomized study. Bertelli, G., Venturini, M., Del Mastro, L., et al.[2020]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06385795

A Study of NOE-115 in Women With Vasomotor Symptoms ... The purpose of this study is to determine the safety, tolerability, and preliminary effectiveness of NOE-115 on moderate to severe vasomotor symptoms (hot ...

2. globenewswire.com globenewswire.com/news-release/2025/11/06/3182391/0/en/Noema-Pharma-Announces-Phase-2a-Study-Results-with-Cendifensine-in-Women-with-Vasomotor-Symptoms-Hot-Flashes-Due-to-Menopause.html

Noema Pharma Announces Phase 2a Study Results with A mean 92.3% reduction from baseline to Week 12 in daily frequency of moderate-to-severe hot flashes, with a mean reduction of 12.3 daily hot ...

3. ctv.veeva.com ctv.veeva.com/study/a-study-of-noe-115-in-women-with-vasomotor-symptoms-due-to-menopause

A Study of NOE-115 in Women With Vasomotor Symptoms ... The purpose of this study is to determine the safety, tolerability, and preliminary effectiveness of NOE-115 on moderate to severe vasomotor ...

4. trial.medpath.com trial.medpath.com/clinical-trial/23c46f27512283ba

A Study of NOE-115 in Women With Vasomotor Symptoms Due to ... The purpose of this study is to determine the safety, tolerability, and preliminary effectiveness of NOE-115 on moderate to severe vasomotor symptoms (hot ...

5. noemapharma.com noemapharma.com/2024/05/22/noema-pharma-announces-first-patient-dosed-in-phase-2a-study-of-noe-115-a-first-in-class-investigational-therapy-for-the-treatment-of-vasomotor-symptoms-and-additional-symptoms-associated-with-menopa/

NOE-115 has the potential to benefit Vasomotor Symptoms ... NOE-115 has the potential to benefit Vasomotor Symptoms (VMS) during menopause as well as associated clinical challenges including weight gain, daytime fatigue ...

6. withpower.com withpower.com/trial/phase-2-menopause-syndrome-3-2024-9d44f

NOE-115 for Hot Flashes Due to Menopause The purpose of this study is to determine the safety, tolerability, and preliminary effectiveness of NOE-115 on moderate to severe vasomotor symptoms (hot ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12572072/

Advances in Pharmacotherapy for Menopausal Vasomotor ... A phase 2a trial (NCT06385795) is testing the effect of NOE-115 on the number of participant withdrawals due to adverse effects for any reason ...