Radicle Revive for Menopause

Overseen By Emily K Pauli

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Radicle Science

Must not be taking: Anticoagulants, Corticosteroids, Antipsychotics, others

Disqualifiers: Pregnancy, Liver disease, Kidney disease, others

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

500 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

You may need to stop taking certain medications if they interact with the study's active ingredients. Specifically, if you are taking anticoagulants, medications that warn against grapefruit consumption, high-dose corticosteroids, certain anti-infectives, antipsychotics, or MAO inhibitors, you might need to stop them to participate.

What data supports the effectiveness of the drug Radicle Revive Active Study Product 4.1 for menopause?

Research shows that estradiol gel, a hormone treatment, effectively relieves menopause symptoms like hot flashes, and raloxifene, another drug, has been studied for menopause effects. These findings suggest that hormone-related treatments can help manage menopause symptoms. ^{1 2 3 4 5}

What is the purpose of this trial?

A randomized, double-blind, placebo-controlled, direct-to-consumer trial assessing the impact of health and wellness products on hormonal health and associated health outcomes in women with menopausal health issues

Eligibility Criteria

This trial is for women experiencing menopause with related issues like depression, insomnia, cognitive problems, anxiety, fatigue, and low sex drive. Specific eligibility details are not provided but typically include age range and health status requirements.

Inclusion Criteria

I am 21 years old or older.

Resides in the United States

My main goal is to reduce my pain.

Exclusion Criteria

Reports being pregnant, trying to become pregnant, or breastfeeding

The calculated validated health survey (PRO) score during enrollment represents less than mild severity

I cannot provide a valid US address and mobile number.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the study product or placebo for 6 weeks, with self-reported data collected electronically

6 weeks

No in-person visits; all assessments are electronic

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Radicle Revive Active Study Product 4.1
• Radicle Revive Placebo Control Form 4.1

Trial Overview The study tests Radicle Revive Active Study Product 4.1 against a placebo to see if it improves menopausal health outcomes. Participants won't know which one they're taking in this randomized and double-blind setup.

Participant Groups

Group I: Active product 4.1.1 Experimental Treatment 1 Intervention

Revive product form 4.1 - active product 1

Group II: Placebo control 4.1.0 Placebo Group 1 Intervention

Revive product form 4.1 - control

Who Is Running the Clinical Trial?

Radicle Science

Lead Sponsor

Trials

24

Recruited

46,200+

Findings from Research

Raloxifene effectively reduces vertebral fractures and improves lipid profiles in post-menopausal women, but it is less effective than estrogen in increasing bone mineral density and improving HDL levels.

While raloxifene significantly lowers the risk of estrogen receptor-positive breast cancer without increasing endometrial cancer risk, it does carry a risk of serious side effects like deep vein thrombosis and pulmonary embolism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of raloxifene for treatment of menopause: a systematic review. Boyack, M., Lookinland, S., Chasson, S.[2022]

Hormonal replacement therapy (HRT) has been shown to provide significant health benefits for menopausal women, improving their quality of life during this natural stage of aging.

The study reviewed 62 randomized controlled trials (RCTs) over the past ten years, highlighting the need for ongoing research into both hormonal and non-hormonal therapies to better address menopause-related symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Current Strategy in Hormonal and Non-Hormonal Therapies in Menopause-A Comprehensive Review. Pop, AL., Nasui, BA., Bors, RG., et al.[2023]

In a study of 29 women experiencing menopause-related fatigue, armodafinil significantly reduced fatigue levels by 57.7% and improved quality of life scores by 49% after 4 weeks of treatment, indicating its efficacy in managing menopause symptoms.

Armodafinil was well-tolerated, with only 12% of participants experiencing adverse events, suggesting it is a safe option for improving menopause-related fatigue and other symptoms like insomnia and depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Armodafinil for fatigue associated with menopause: an open-label trial. Meyer, F., Freeman, MP., Petrillo, L., et al.[2018]

In a study of 187 postmenopausal women with vaginal atrophy, both conjugated estrogen cream and nonhormonal moisturizer improved symptoms, showing that these treatments can be effective options.

Raloxifene, taken at a dose of 60 mg per day, did not interfere with the effectiveness of either treatment, allowing women to safely use it alongside estrogen cream or moisturizer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of raloxifene on the response to conjugated estrogen vaginal cream or nonhormonal moisturizers in postmenopausal vaginal atrophy. Parsons, A., Merritt, D., Rosen, A., et al.[2019]

Estradiol gel 0.1% significantly reduced the frequency and severity of moderate to severe vasomotor symptoms in postmenopausal women, regardless of their age, uterine status, or ovarian status, based on a reanalysis of a phase III clinical trial.

The study found no interactions between the treatment and factors like age or surgical history, indicating that estradiol gel is effective across different demographics of postmenopausal women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Estradiol gel 0.1% relieves vasomotor symptoms independent of age, ovarian status, or uterine status. Hedrick, RE., Ackerman, RT., Koltun, WD., et al.[2013]

References

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

Efficacy of raloxifene for treatment of menopause: a systematic review. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

The Current Strategy in Hormonal and Non-Hormonal Therapies in Menopause-A Comprehensive Review. [2023]

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

Armodafinil for fatigue associated with menopause: an open-label trial. [2018]

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

Effect of raloxifene on the response to conjugated estrogen vaginal cream or nonhormonal moisturizers in postmenopausal vaginal atrophy. [2019]

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

Estradiol gel 0.1% relieves vasomotor symptoms independent of age, ovarian status, or uterine status. [2013]