Clinical Trials

In 1971, a team of researchers reversed menopause in aging rats by restoring their hypothalamic function using an early prototype of Amberen. Since then, Amberen’s formulation and its main ingredients have been researched and clinically tested by renowned scientists and doctors to test its efficacy in helping women manage symptoms related to climacteric syndrome, or as it is more commonly known, menopause.

The scientific foundation that supports Amberen’s effectiveness and safety is substantial and includes three randomized, double-blind, placebo-controlled clinical studies on menopausal and perimenopausal women and over 45 years of research on its ingredients.

Here is the list of human clinical trials, report summaries and publications.

2015-2016, The Peoples’ Friendship University of Russia. Title: “Clinical evaluation of effectiveness and safety of supplement Amberen as a treatment for the climacteric syndrome”.

Summary: a double-blind, comparative, randomized, placebo-controlled 12-week study for the treatment of the climacteric syndrome. This trial involved one hundred and twenty five (125) menopausal and perimenopausal women, between 42 and 60 years of age, with mild to moderate menopausal symptoms. Based on the results of the statistical and dynamic analysis, the following symptoms showed statistically significant (p < 0.05) improvements in Amberen patients: hot flashes, night sweats, difficulty sleeping, increased excitability, difficulty concentrating, feeling tired or lacking energy, mood swings, irritability, headaches, muscle and joint aches and lack of sexual interest, among others. During the course of the treatment and by the end of the study, the patients who took Amberen showed dynamically significant increase in the estradiol levels and decreases in the levels of FSH and LH, body mass, hip and waste circumferences. Clinical evaluation of Amberen, including primary indicators (improvements in vasomotor, endocrine, and neuropsychiatric functions), proved Amberen to be a safe, well-tolerated, and effective therapy for the climacteric syndrome.

2014-2015, I.M. Sechenov Moscow State Medical University, University Hospital #2, OBGYN Clinic. Title: “Clinical evaluation of effectiveness and safety of supplement Amberen as a treatment for climacteric syndrome”.

Summary: a double-blind, comparative, randomized, placebo-controlled 12-week study for the treatment of the climacteric syndrome. The clinical trial involved one hundred two (102) menopausal and perimenopausal women, ranging from 42 to 60 years of age, with mild to moderate menopausal symptoms. Based on the results of the statistical and dynamic analysis, the following symptoms showed statistically significant (p < 0.05) improvements in Amberen patients: hot flashes, night sweats, irritability, mood swings, sleeplessness, stress and anxiety, difficulty concentrating, headaches, muscle and joint aches, and lack of sexual interest, among others. Dynamic and statistically significant changes in levels of estradiol, FSH and LH, body mass, and hip and waist circumferences were also observed. Clinical evaluation of Amberen, including primary indicators (improvements in vasomotor, endocrine, and neuropsychiatric functions), proved Amberen to be a safe and effective therapy for the climacteric syndrome.

2001, Ulianovsk medical hospital #1, Russia

Title: “Evaluation of Enerlit (current: Amberen) as a treatment for climacteric syndrome “.

Summary: a double-blind, randomized, placebo-controlled 90-day human clinical study for the treatment of climateric syndrom on seventy (70) menopausal women. Based on the results, Amberen-based therapy lowered many characteristics of menopausal symptoms with statistical significance when compared with placebo group. Those symptoms include hot flashes, sleeplessness, headache, irritability, fatigue and muscle and joint aches. A clinically important alleviation of low libido, headaches and other symptoms was also observed. Additionally, blood tests revealed that Amberen was increasing the levels of estradiol in those Amberen-treated participants whose estradiol was lower than normal in pre-trial period. No adverse side effects of Amberen were registered. The results of this study have been published in three out of four peer-reviewed publications below.

Publications (2005 – up to date):

  • Efficiency of alternative therapy in perimenopausal and postmenopausal women.

    Kuznetsova I.V., Uspenskaya Yu.B., Borisova N.I., Zhukova E.V., Berdnikova N.G., Gusak Yu.K. Efficiency of alternative therapy in perimenopausal and postmenopausal women. Akusherstvo i ginekologiya/Obstetrics and Gynecology. 2016; (5): (in Russian) http://dx.doi.org/10.18565/aig.2016.5

  • Succinate-Based Preparation Alleviates Manifestations of the Climacteric Syndrome in Women.

    Succinate-Based Preparation Alleviates Manifestations of the Climacteric Syndrome in Women. Bulletin of Experimental Biology and Medicine, Vol. 140, No. 3 (New York, 2005).

  • A Succinate-Based Composition ‘Rejuvenates’ Aging Mice and Alleviates Menopausal Symptoms in Women Without Sex Hormone Replacement Therapy

    A Succinate-Based Composition ‘Rejuvenates’ Aging Mice and Alleviates Menopausal Symptoms in Women Without Sex Hormone Replacement Therapy. Medline, Vol. 8, Art. 46, at pp. 497-517 (2007).

  • A Succinate-Based Composition Reverses Menopausal Symptoms Without Sex Hormone Replacement Therapy.

    A Succinate-Based Composition Reverses Menopausal Symptoms Without Sex Hormone Replacement Therapy. Advances in Gerontology, Vol. 21, No. 2, at pp. 298-305 (2008).

  • Maintenance of homeostasis in the aging hypothalamus: the central and peripheral roles of succinate.

    Chen TT, Maevsky EI and Uchitel ML. Maintenance of homeostasis in the aging hypothalamus: the central and peripheral roles of succinate. Front. in Endocrinol. (2015) 6:7 doi.org/10.3389/fendo.2015.00007

Complete list of publications that comprise the body of science substantiating Amberen’s mechanism of action can be found here. Please note that many of these articles are available only in Russian language.