NOE-115 for Hot Flashes Due to Menopause
Recruiting in Palo Alto (17 mi)
+4 other locations
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.
12345Eligibility 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.
+3 more
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)
+7 more
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
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: NOE-115Experimental Treatment1 Intervention
Escalating doses of NOE-115 capsules
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Noema PMM-201 Site #101Atlanta, GA
Noema PMM-201 Site #102Jacksonville, FL
Noema PMM-201 Site #104San Diego, CA
Noema PMM-201 Site #106Las Vegas, NV
More Trial Locations
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Who Is Running the Clinical Trial?
Noema Pharma AGLead Sponsor
References
Low-dose transdermal estradiol for vasomotor symptoms: a systematic review. [2018]This review aims to determine the effectiveness of low-dose transdermal estrogen versus placebo in postmenopausal women with moderate to severe hot flashes.
Effective and clinically meaningful non-hormonal hot flash therapies. [2023]Although many non-hormonal compounds have shown statistically significant benefit over placebo in hot flash randomized controlled trials (RCTs), these studies have varied considerably in basic methodology making it challenging to deduce which compounds have the greatest potential to provide clinically meaningful benefit. This review used evidence-based methodology closely mirroring the FDA and EMEA guidelines as a template to identify "well-designed" RCTs from which effective and clinically meaningful non-hormonal hot flash therapies could be identified. In addition, pertinent safety information was reviewed. Out of 3548 MEDLINE citations and abstracts, 51 well-designed hot flash RCTs were identified. From these trials, gabapentin, oxybutynin ER, desvenlafaxine, soy-derived isoflavones and black cohosh each showed a clinically meaningful treatment effect in at least 1 RCT. Among these 5 compounds, only gabapentin demonstrated consistent and statistically significant benefit over placebo in all of its well-designed RCTs. Desvenlafaxine, soy-derived isoflavones, and black cohosh demonstrated statistically significant benefit over placebo in 75%, 21%, and 17% of the well-designed RCTs for each compound, respectively. There was only 1 well-designed RCT using oxybutynin ER, which showed it to have a robust and clinically meaningful benefit. In terms of safety, there have been cardiovascular risks associated with desvenlafaxine use in postmenopausal women with hot flashes. The use of anticonvulsants, in general, has been associated with an absolute 0.21% increase in suicidal thoughts and behavior. Further research is needed with several of these nonhormonal compounds to replicate these findings and to also directly compare their efficacy and tolerability with those of hormone replacement therapy.
Adverse effects of non-hormonal pharmacological interventions in breast cancer survivors, suffering from hot flashes: A systematic review and meta-analysis. [2018]To access frequency and severity of adverse effects (AE) of non-hormonal drugs (NHD) for hot flashes in breast cancer survivors compared to controls and analyze adverse-effect risk by reviewing published randomized trials.
Intramuscular depot medroxyprogesterone versus oral megestrol for the control of postmenopausal hot flashes in breast cancer patients: a randomized study. [2020]Hot flashes are frequent in postmenopausal breast cancer patients, especially when treated with tamoxifen. Estrogen replacement therapy is the most effective treatment for hot flashes, but its use is controversial in breast cancer survivors. Progestins may offer a good alternative for the control of hot flashes in this setting; in particular, oral megestrol acetate has been proven effective in a randomized, placebo-controlled clinical trial. With the aim of further improving these results, we have designed a randomized study comparing oral megestrol acetate with depot intramuscular (i.m.) medroxyprogesterone acetate (MPA) for the control of hot flashes in postmenopausal patients with a history of breast cancer.
Minimal decrease in hot flashes desired by postmenopausal women in family practice. [2007]To determine the minimal important difference in the frequency and severity of hot flashes that postmenopausal women desire from a nonhormonal agent.