Radicle Revive for Menopause
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Radicle Science
Must not be taking: Anticoagulants, Corticosteroids, Antipsychotics, others
Disqualifiers: Pregnancy, Liver disease, Kidney disease, others
Trial Summary
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
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?
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.
See 2 more
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.
See 7 more
Trial 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 (Dietary Supplement)
- Radicle Revive Placebo Control Form 4.1 (Dietary Supplement)
Trial OverviewThe 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
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active product 4.1.1Experimental Treatment1 Intervention
Revive product form 4.1 - active product 1
Group II: Placebo control 4.1.0Placebo Group1 Intervention
Revive product form 4.1 - control
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Radicle Science, IncDel Mar, CA
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Who Is Running the Clinical Trial?
Radicle ScienceLead Sponsor
References
Efficacy of raloxifene for treatment of menopause: a systematic review. [2022]To critically appraise recent randomized controlled trials (RCT) of raloxifene and its effects on the long-term consequences of menopause.
The Current Strategy in Hormonal and Non-Hormonal Therapies in Menopause-A Comprehensive Review. [2023]Menopause is a natural stage of hormonal aging in women, accompanied by a series of symptoms that reduce the quality of life of a fully active person. As no therapy is entirely satisfactory, the race for a better option is in full swing. Our study objective is to investigate the most recent menopause studies on pharmacological resources, emerging therapies, and the particularities of hormonal replacement therapy (HRT). For this purpose, a comprehensive search was conducted in two main databases (PubMed and Web of Science) guided by the specific keywords "menopause" and "therapy" or "estrogen" or "progesterone" or "hormone replacement" during the last ten years period. Studies were eligible if they met certain criteria: randomized controlled trials (RCT) in adult women with menopause and hormonal or non-hormonal therapies. We selected 62 RCTs, which are focused on four main topics: (a) epidemiology of menopause-related symptoms, (b) hormonal replacement therapy (HRT) selective estrogen receptor modulators, (c) emerging therapies, and (d) menopause. HRT has proven a real health benefit for menopausal women; besides, complementary interventions must be considered. Further studies are needed on menopause and menopause-related therapies. The continuous updating of clinical experience will strengthen the therapeutic benefit and the decision to treat patients safely. This goal will fully access all therapeutic resources to address an unresolved health issue of active adult women.
Armodafinil for fatigue associated with menopause: an open-label trial. [2018]This study aims to obtain preliminary data on the efficacy of armodafinil for improving menopause-related fatigue and quality of life.
Effect of raloxifene on the response to conjugated estrogen vaginal cream or nonhormonal moisturizers in postmenopausal vaginal atrophy. [2019]To study the effect of raloxifene on the response to conjugated estrogen cream or nonhormonal moisturizer in postmenopausal women with preexisting signs of vaginal atrophy.
Estradiol gel 0.1% relieves vasomotor symptoms independent of age, ovarian status, or uterine status. [2013]Data from a pivotal efficacy trial have been reanalyzed to explore the impact of age, uterine status, and ovarian status on the efficacy of estradiol gel 0.1% (Divigel) for the treatment of moderate to severe vasomotor symptoms associated with menopause.