The Bonafide Standard | Clinical Trials, Testing and Safety (2024)

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The Bonafide Standard | Clinical Trials, Testing and Safety (1)

The Bonafide Standard | Clinical Trials, Testing and Safety (2)

Clinical trials determine if products work and are safe

Unlike many supplement brands that don’t test their products, Bonafide prioritizes safety and effectiveness by requiring clinical testing for all products. This approach gives customers and healthcare providers peace of mind knowing that our claims are supported by rigorous evidence

Over

13,000

women have participated in Bonafide clinical studies and surveys †

35+ clinical trials and counting

Clairvee® relieves vagin*l odor, itching, and discharge in women without an infection in just 15 days with continued relief over 6 months¹⁻²

The Bonafide Standard | Clinical Trials, Testing and Safety (4)

Clairvee is a vagin*l probiotic taken orally, 
1 capsule per day for 15 days each month.

In a randomized, double-blind, placebo-controlled trial of 40 symptomatic patients without an infection on culture (nugent score of 4-6)

In an open-label trial of women with moderate-to-severe vagin*l odor and no known infection¹

74% of women reported a reduction in vagin*l odor at 2 weeks

6 months

0%

25%

50%

75%

100%

100% of women reported a reduction in vagin*l odor at 6 months

% of women reporting a reduction in odor

In the same study, 93% of women studied reported that they prefer Clairvee to other OTC products for vagin*l symptoms¹

In a separate study, 75% of women reported improvements in vagin*l itching and discharge vs. placebo in 15 days²

Revaree®, made from hyaluronic acid, relieves vagin*l dryness with no hormonal effect.³

The Bonafide Standard | Clinical Trials, Testing and Safety (5)

Revaree is a vagin*l suppository, inserted into the vagin* 2-3 times per week.

The Bonafide Standard | Clinical Trials, Testing and Safety (6) The Bonafide Standard | Clinical Trials, Testing and Safety (7)

In a survey of more than 3,000 women, 96% of women plan to continue using Revaree.⁵

Relizen® significantly reduces frequency and intensity of hot flashes without hormones.*⁶

The Bonafide Standard | Clinical Trials, Testing and Safety (8)

Relizen is taken orally, 2 tablets per day for 30 days each month.

The Bonafide Standard | Clinical Trials, Testing and Safety (9) The Bonafide Standard | Clinical Trials, Testing and Safety (10)

In a separate survey of more than 4,900 women, 85% reported they plan to continue taking Relizen.⁸

Ristela® significantly improves sexual function across all stages of a women's life.*⁹⁻¹¹

The Bonafide Standard | Clinical Trials, Testing and Safety (11)

Ristela is taken orally, 2 tablets per day for 30 days each month.

The Bonafide Standard | Clinical Trials, Testing and Safety (12) The Bonafide Standard | Clinical Trials, Testing and Safety (13)

In three separate clinical studies, Ristela was shown to significantly improve Female Sexual Function Index (FSFI) scores after 2 months ⁹⁻¹¹

Serenol™ significantly reduces irritabillity, mood swings, uneasiness, and overall PMS severity*¹³

The Bonafide Standard | Clinical Trials, Testing and Safety (14)

Serenol is taken orally, 2 tablets per day for 30 days each month.

The Bonafide Standard | Clinical Trials, Testing and Safety (15) The Bonafide Standard | Clinical Trials, Testing and Safety (16)

In a separate survey of more than 500 women, 75% experienced relief within 3 months and 82% reported that they plan to continue using Serenol¹⁴

Silvessa® improves the health and appearance of hair and skin affected by estrogen decline during menopause.*¹⁵⁻¹⁷

The Bonafide Standard | Clinical Trials, Testing and Safety (17)

Silvessa capsule is taken orally, 1 capsule per day for 30 days each month. Silvessa serums are applied topically, 2 droplets for hair and 2 pumps for skin per day.

The Bonafide Standard | Clinical Trials, Testing and Safety (18) The Bonafide Standard | Clinical Trials, Testing and Safety (19)

In the same study, 100% of women told us they were satisfied with how healthy their facial skin looked.¹⁵⁻¹⁶

The gold standard in clinical trials

We use the gold standard of product testing: double-blinded placebo-controlled trials. Neither the participants nor the study team know who received the placebo or the supplement.

This rigorous research method is used to provide reliable and unbiased evidence of our product's effectiveness and safety. It helps healthcare providers make informed decisions about patient treatment and gives consumers confidence in the quality of the products they purchase.

The Bonafide Standard | Clinical Trials, Testing and Safety (20)The Bonafide Standard | Clinical Trials, Testing and Safety (21)

Join our participant community

Our Bonafide research team is passionately committed to developing new formulations to further support women’s health. We invite you to join our participant community and discover how you can contribute to the testing of new products that address menopausal symptoms.




As a participant, you contribute to advancing women’s health research and gain an opportunity to access new innovative products before they come to market. Help us make a difference in the lives of countless women.

Join our community and start participating

The Bonafide Standard | Clinical Trials, Testing and Safety (22)The Bonafide Standard | Clinical Trials, Testing and Safety (23)

The Bonafide Standard | Clinical Trials, Testing and Safety (24)

Bonafide difference

* These statements have not been evaluated by the Food and Drug Administration. These products are not intended to diagnose, treat, cure, or prevent any disease.

  • † Clinical trials were either conducted on Bonafide products or a key ingredient contained within Bonafide products.

  • ¹ Results from an open-label clinical study.
    ² Russo R, Edu A, De Seta F. Arch Gynecol Obstet. 2018; 298(1):139-145.

  • ³ Liu SB, et al. Gynecol Endocrinol. 2015;31:208-213. Preclinical study.
    ⁴ Chen J, et al. J Sex Med. 2013:10:1575-1584. Results based on Revaree's main ingredient, Hyaluronic Acid.
    ⁵ Dweck A, et al. J Sex Med. 2022;19(Supplement 3):S26.

  • ⁶ Winther K, et al Climateric 205;8:162-170
    ⁷ Elia D, Mares P. Genesis. 2008;135:12-15.
    ⁸ Bernsley D, Sylla S, Komorowski J. Menopause. 2021;28(12):P-4.

  • ⁹ Bottari A, et al. Panminerva Med. 2012;54:3-9. 8-week, single-blinded trial in 83 post-menopausal women ages 45 to 55.
    ¹⁰ Stanislavov R and Rohdewald P. J Women's Health Care. 2014;3:1-6. 8-week, randomized, double-blind, placebo-controlled study conducted in 80 women ages 40-50.
    ¹¹ Bottari A, et al. Panminerva Med. 2012;54:3-9. 8-week, single-blinded trial in 83 post-menopausal women ages 45 to 55.
    ¹² Kellog Spadt S, et al. Effects of Ristela supplementation on female sexual satisfaction: an open-label trial. Menopause. 2019:26(12):1467-1468.

  • ¹³ Winther K. Hedman C., Curr Ther Res Clin Exp. 2002;63(5):344-353.
    ¹⁴ Results are from an optional, rolling online survey, conducted from July 2016 through November 2017, that included 500 customers who were taking Serenol for at least 3 months. Patients were compensated for completing the survey.

  • ¹⁵ Sylla S, et al. Current Developments in Nutrition. 2021; 5:Supplement_2:37.
    ¹⁶ Open-label extension data on file.
    ¹⁷ Kalman & Hewlings. J Clin Exp Dermatol Res. 2021;12:551.

The Bonafide Standard | Clinical Trials, Testing and Safety (2024)

FAQs

What happens before a clinical trial? ›

Before a clinical trial begins, researchers review prior information about the drug to develop research questions and objectives. Then, they decide: Who qualifies to participate (selection criteria) How many people will be part of the study.

What are the 4 types of clinical trials? ›

There are different types of clinical trials that include those which are conducted for treatment, prevention, early detection/screening, and diagnosis.

Are bonafide products safe? ›

Together with our FDA-registered manufacturing facilities, we rigorously test our products and ingredients to ensure they're safe and of the highest quality.

What is safety testing in clinical trials? ›

Safety testing includes a set of assays used to test preclinical and clinical vector product lots prior to use in animals or humans. Some of the same tests are performed to ensure that the RSMs are free of detectable contaminating agents or process residuals that could interfere with subsequent analytical testing.

What clinical trials pay the most? ›

For example, Phase 1 trials offer the highest payments (around $2,000 on average), but this is because the treatments being studied are less well-understood. Phase IV trials, in comparison, offer the lowest average compensation (around $400).

Are clinical trials a good way to make money? ›

One of the most significant advantages of participating in clinical trials is the compensation. Depending on the study's complexity and duration, participants can earn a substantial amount of money. This can be particularly appealing if you're looking to supplement your income or save for a specific goal.

Is Bonafide FDA approved? ›

However, Bonafide does go to great lengths to ensure its product quality and safety, such as meeting all FDA manufacturing safety requirements, in-house testing, and third-party testing and certifications. These include NSF and USP certifications.

How long does it take for Bonafide to work? ›

From the United States. I would highly recommend this product! Even though it says that it could take up to two months for it to work; I was fortunate that it only took two weeks and I saw benefits from this. I would highly recommend for women to try this product.

How long has Bonafide been on the market? ›

Founded in 2017, Bonafide Health offers drug- and hormone-free products to reduce menopausal and premenstrual symptoms.

What happens after a clinical trial ends? ›

What happens when a clinical trial or study ends? Once a clinical trial or study ends, the researchers analyze the data to determine what the findings mean and to plan the next steps.

How do you ensure safety in a clinical trial? ›

Clinical trials that test an intervention are closely supervised by a Data and Safety Monitoring Board. The board is made up of experts who review the results of the study as it progresses. If they determine that the experimental treatment is not working or is harming participants, they can stop the trial early.

Do you have to pay to participate in a clinical trial? ›

You may also wonder if clinical trials are free. Many clinical trial costs are covered by the sponsor of the study, a patient's insurance plan if one is available, and sometimes there are out-of-pocket costs.

What is the pre clinical trial process? ›

Preclinical research is a term that refers to, simply, any research about a drug or treatment for a disease that occurs before it is tested by human volunteers. This encompasses everything from experiments to investigate the causes of the disease to testing potential treatments in animals, and everything in between.

What are the four stages of clinical trials? ›

The four main phases of clinical trials, which will be explained further below, are: Phase 1 - Assessing initial safety and dosage Phase 2 - Evaluating effectiveness and side effects Phase 3 - Confirming efficacy compared to standard treatments Phase 4 - Ongoing study of long-term effects after approval Understanding ...

What is the start up timeline for clinical trials? ›

The study startup stage typically involves the first three months of the clinical trial. During this time, there are some critical steps to getting the study started effectively.

What is the timeline for clinical trials? ›

This process can take a long time — in most cases, an average of 10 years will pass between initial discovery to full approval, with the clinical trial stages taking six to seven years of that time.

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