NOE-115 for Hot Flashes Due to Menopause

Recruiting at 4 trial locations

Overseen By Noema Pharma Clinical

Age: 18 - 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Noema Pharma AG

Must not be taking: Cannabis, others

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

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The purpose of this study is to determine the safety, tolerability, and preliminary effectiveness of NOE-115 on moderate to severe vasomotor symptoms (hot flashes) due to menopause in women.

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.

What data supports the effectiveness of the drug NOE-115 for treating hot flashes due to menopause?

The review on low-dose transdermal estrogen shows that estrogen can be effective for hot flashes, suggesting that hormone-based treatments like NOE-115 might also be effective. Additionally, non-hormonal treatments such as gabapentin and soy-derived isoflavones have shown benefits in reducing hot flashes, indicating that alternative approaches can be effective. ^{1 2 3 4 5}

Research Team

Clinical Director, MD

Principal Investigator

Noema Pharma AG

Eligibility Criteria

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)

Trial Timeline

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

Treatment Details

Interventions

• NOE-115 (Hormone Therapy)

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Low-dose transdermal estradiol for vasomotor symptoms: a systematic review. [2018]

2. Ireland pubmed.ncbi.nlm.nih.gov

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

3. Netherlands 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. [2018]

4. England 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. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Minimal decrease in hot flashes desired by postmenopausal women in family practice. [2007]