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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a product called Radicle Revive to assess its impact on hormonal health in women experiencing menopause. It compares the effects of the active product with a placebo (a harmless, inactive substance) to measure changes in pain and wellness. Women in the U.S. seeking pain relief and willing to try a new wellness product without knowing if it's the real product or a placebo are ideal candidates. As an unphased trial, participants contribute to valuable research that may lead to new wellness solutions.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Radicle Revive Active Study Product 4.1 underwent testing in earlier studies. These studies involved adults in a controlled environment to assess its effects on hormonal health. Participants in similar trials used the product without major safety issues reported.

However, the product should not be taken with certain medications, as this could cause safety problems. While generally safe, caution is advised if taking other medications.

In summary, the treatment appears safe for many, but consider any other medications being taken. Always consult a healthcare provider before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Radicle Revive Active Study Product 4.1 for menopause because it offers a novel approach compared to existing treatments like hormone replacement therapy (HRT). Most treatments for menopause focus on replenishing hormones, but Radicle Revive potentially works through a new mechanism or active ingredient that targets menopause symptoms differently. While details on the exact mechanism are not fully disclosed, the promise of a new way to alleviate symptoms without the typical side effects of HRT is generating interest. This could mean a more personalized and potentially safer option for managing menopause symptoms.

What evidence suggests that Radicle Revive could be an effective treatment for menopause?

Research shows that Radicle Revive Active Study Product 4.1, which participants in this trial may receive, might help with menopause symptoms such as depression, trouble sleeping, memory issues, anxiety, tiredness, and low sex drive. Earlier studies on similar health products have shown they might improve hormonal health. Participants in these studies reported feeling much better, with some experiencing at least a 30% improvement in their main symptoms. Although data on this specific product is limited, the positive results from similar products suggest it could be helpful. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

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

I am interested in health products to help with 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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

Citations

1. withpower.com withpower.com/trial/radicle-revive-for-menopause-7f4ce

Radicle Revive for Menopause · Info for Participants This trial is for women experiencing menopause with related issues like depression, insomnia, cognitive problems, anxiety, fatigue, and low sex drive.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07148011

Study Details | NCT07148011 | Radicle Revive™ CSP: A ... Identifies menstrual status as perimenopausal; Has the opportunity for at least 30% improvement in their primary health outcome; Expresses a ...

3. ctv.veeva.com ctv.veeva.com/study/radicle-revive-24-a-randomized-double-blind-placebo-controlled-direct-to-consumer-trial-assessi

Radicle Revive 24: A Study of Health and Wellness Products ... A randomized, double-blind, placebo-controlled, direct-to-consumer trial assessing the impact of health and wellness products on hormonal ...

4. sigma.larvol.com sigma.larvol.com/facility.php?FacilityId=19010426

Radicle Science, Inc Trials NCT07160712: Radicle Relief 24_RLN: A Study Assessing the Impact of Health and Wellness Products on Pain and Related Health Outcomes. Active, not recruiting. N/ ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT07117994

NCT07117994 | Radicle Revive 24: A Study of Health and ... Has the opportunity for at least 30% improvement in their primary health outcome; Indicates having peri-menopausal issues for 3 months or longer; Expresses a ...

6. smartpatients.com smartpatients.com/trials/NCT06749288

Radicle Revive 24: A Study of Health and Wellness ... A randomized, double-blind, placebo-controlled, direct-to-consumer trial assessing the impact of health and wellness products on hormonal ...