Clinically Tested Formulation

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 main ingredients, succinates.

Choosing a clinically tested supplement is a relief on its own.

Amberen Clinical Trials

Amberen clinical trials are driven by the aim to improve women’s quality of life during menopause.

Clinical evaluation of effectiveness and safety of supplement Amberen as a treatment for climacteric syndrome

Study design: Double-blind, randomized, placebo-controlled, 12-week study on 125 peri- and menopausal women of 42–60 years of age with mild to moderate menopause symptoms.

Results: Amberen was shown to be a safe and well-tolerated supplement with no registered side effects. Compared to the placebo group, women who took Amberen reported statistically significant improvements in many menopausal symptoms. The manuscript describing the results of this clinical trial is currently being prepared for publication.

Publications: Treatment of climacteric symptoms with an ammonium succinate-based dietary supplement: a randomized, double-blind, placebo-controlled trial. V. E. Radzinskii, I. V. Kuznetsova, Y. B. Uspenskaya, N. B. Repina, Y. K. Gusak, O. M. Zubova, D. I. Burchakov & A. A. Osmakova (2016) Treatment of climacteric symptoms with an ammonium succinate-based dietary supplement: a randomized, double-blind, placebo-controlled trial, Gynecological Endocrinology, 32:sup2, 64-68, DOI: 10.1080/09513590.2016.1232686

Presentations: Oral presentation of the 2015/2016 Amberen clinical trial results By Y.B. Uspenskaya: International Menopause Society, 25th World Congress on Controversies in Obstetrics, Gynecology and Infertility, Amsterdam, Netherlands, November 10-13, 2016.
Clinical evaluation of effectiveness and safety of supplement Amberen as a treatment for climacteric syndrome

Study design: Double-blind, randomized, placebo-controlled, 12-week study on 102 peri- and menopausal women between 42 and 60 years of age with mild to moderate menopause symptoms.

Results: Compared to the placebo group, many menopause symptoms showed statistically significant improvement in women who took Amberen. The results of the safety evaluation proved Amberen to be a safe dietary supplement.

Publications: Kuznetsova I.V. UYB, Borisova N.I., Zhukova E.V., Berdnikova N.G., Gusak Yu.K. Akusherstvo i ginekologiya/Obstetrics and Gynecology. Effectiveness of alternative therapy in perimenopausal and postmenopausal women (in Russian). Akusherstvo i ginekologiya/Obstetrics and Gynecology. 2016 5:126 - 33.

Effectiveness and safety of using a succinate-based dietary supplement for women in menopause. Kuznetsova I.V, Uspenskaya Yu. B., Borisova N.I, , Zhukova E.V., Berdnikova N.G., Gusak Yu. K Effectiveness and safety of using a succinate-based dietary supplement for women in menopause. Medline.ru, 2016, Vol 17, Art. 3, p 24-45 (Mecine.ru/pdf)

Presentations: Poster presentation at the 15th World Congress on Menopause. Effectiveness and safety of using Amberen supplementation in perimenopausal and postmenopausal women.Yu. Uspenskaya, I. Kuznetsova, N. Borisova, N. Berdnikova and U. Gusak
Evaluation of Enerlit-Clima (equivalent of Amberen’s formulation) as a treatment for climacteric syndrome

Study design: This double-blind, randomized, placebo-controlled, 3-week study involved 70 menopausal women.

Results: The results of the study demonstrated that Enerlit-Clima-based therapy helps alleviate many menopause symptoms when compared with the placebo group. No adverse side effects of Enerlit-Clima were registered.

Publications: Maevsky, E. I., et al. “A succinate-based composition reverses menopausal symptoms without sex hormone replacement therapy.” Advances in gerontology= Uspekhi gerontologii/Rossiiskaia akademiia nauk, Gerontologicheskoe obshchestvo 21.2 (2008): 298-305.

Clinical evaluation of effectiveness and safety of supplement Amberen as a treatment for climacteric syndrome

Study design: Double-blind, randomized, placebo-controlled, 12-week study on 125 peri- and menopausal women of 42–60 years of age with mild to moderate menopause symptoms.

Results: Amberen was shown to be a safe and well-tolerated supplement with no registered side effects. Compared to the placebo group, women who took Amberen reported statistically significant improvements in many menopausal symptoms. The manuscript describing the results of this clinical trial is currently being prepared for publication.

Publications: Treatment of climacteric symptoms with an ammonium succinate-based dietary supplement: a randomized, double-blind, placebo-controlled trial. V. E. Radzinskii, I. V. Kuznetsova, Y. B. Uspenskaya, N. B. Repina, Y. K. Gusak, O. M. Zubova, D. I. Burchakov & A. A. Osmakova (2016) Treatment of climacteric symptoms with an ammonium succinate-based dietary supplement: a randomized, double-blind, placebo-controlled trial, Gynecological Endocrinology, 32:sup2, 64-68, DOI: 10.1080/09513590.2016.1232686

Presentations: Oral presentation of the 2015/2016 Amberen clinical trial results By Y.B. Uspenskaya: International Menopause Society, 25th World Congress on Controversies in Obstetrics, Gynecology and Infertility, Amsterdam, Netherlands, November 10-13, 2016.

Clinical evaluation of effectiveness and safety of supplement Amberen as a treatment for climacteric syndrome

Study design: Double-blind, randomized, placebo-controlled, 12-week study on 102 peri- and menopausal women between 42 and 60 years of age with mild to moderate menopause symptoms.

Results: Compared to the placebo group, many menopause symptoms showed statistically significant improvement in women who took Amberen. The results of the safety evaluation proved Amberen to be a safe dietary supplement.

Publications: Kuznetsova I.V. UYB, Borisova N.I., Zhukova E.V., Berdnikova N.G., Gusak Yu.K. Akusherstvo i ginekologiya/Obstetrics and Gynecology. Effectiveness of alternative therapy in perimenopausal and postmenopausal women (in Russian). Akusherstvo i ginekologiya/Obstetrics and Gynecology. 2016 5:126 - 33.

Effectiveness and safety of using a succinate-based dietary supplement for women in menopause. Kuznetsova I.V, Uspenskaya Yu. B., Borisova N.I, , Zhukova E.V., Berdnikova N.G., Gusak Yu. K Effectiveness and safety of using a succinate-based dietary supplement for women in menopause. Medline.ru, 2016, Vol 17, Art. 3, p 24-45 (Mecine.ru/pdf)

Presentations: Poster presentation at the 15th World Congress on Menopause. Effectiveness and safety of using Amberen supplementation in perimenopausal and postmenopausal women. Yu. Uspenskaya, I. Kuznetsova, N. Borisova, N. Berdnikova and U. Gusak

Evaluation of Enerlit-Clima (equivalent of Amberen’s formulation) as a treatment for climacteric syndrome

Study design: This double-blind, randomized, placebo-controlled, 3-week study involved 70 menopausal women.

Results: The results of the study demonstrated that Enerlit-Clima-based therapy helps alleviate many menopause symptoms when compared with the placebo group. No adverse side effects of Enerlit-Clima were registered.

Publications: Maevsky, E. I., et al. “A succinate-based composition reverses menopausal symptoms without sex hormone replacement therapy.” Advances in gerontology= Uspekhi gerontologii/Rossiiskaia akademiia nauk, Gerontologicheskoe obshchestvo 21.2 (2008): 298-305.

Scientific History Behind Amberen

The Amberen formulation today is the result of decades of complex, rigorous testing and scientific discoveries. Please find below the most relevant achievements from the last 45 years of research on both the Amberen formulation and its main ingredients.

The first experiments to use small doses of amber (succinic) acid to rejuvenate the hypothalamus by restoring its sensitivity were conducted by V.M. Dilman, V.N. Anisimon, and M.N. Kondrashova. Reference: V.M. Dilman, V.N. Anisimon, and M.N. Kondrashova. The influence of succinic (amber) and glutamic acids on the sensitivity of hypothalamo-gonadotropic system to inhibitory action of estrogens in old rats. Pharmacology and Toxicology 3, 540-551, 1976 (In Rus).

In the early 1970s, Dr. Dilman assembled a team of researchers, which included Dr. Maria Kondrashova, to conduct an experiment exploring whether injecting succinic acid into the brain of aging mice, as models of menopause, could restore the hormone-balancing function of the hypothalamus. The results exceeded all expectations. Not only did succinic acid injections reverse menopausal changes in mice, but the animals also exhibited very distinct signs of rejuvenation. Their energy levels increased, yellow patches disappeared from their fur, their eyes brightened and their behavioral patterns were similar to those of much younger animals (Dilman 1976).

Enerlit-Clima (equivalent of Amberen’s formulation) composition was developed by M. Uchitel, MBA, and Dr.Maevsky, MD. In preclinical trials, the supplement was shown to have no toxicity (acute or long term) and to be effective for the alleviation of many menopausal symptoms.

A randomized, double-blind, placebo-controlled, 90-day clinical trial on the effects of Enerlit-Clima (equivalent of Amberen’s formulation) on the symptoms of climacteric syndrome was conducted. Seventy patients completed the trial. The supplement was shown to be effective at relieving many menopausal symptoms. Reference: Peskov A.B., Maevsky E.I., Uchitel M.L., Sakharova N.Yu., Vize-Khripunova M.A. Succinate-based preparation alleviates manifestations of the climacteric syndrome in women. Bulletin of Experimental Biology and Medicine. 2005. Т. 140. № 3. С. 312-314. )

A 3-year-long observational clinical study on 245 women was conducted. Amberen was shown to be safe and effective when it came to managing several menopausal symptoms.

A US patent was granted to Lunada Biomedical (which had acquired the rights to Amberen’s proprietary formulation in 2006) for a method of synthesizing biologically active succinic acid (Patent No: US 8,546,611 B2. Date of patent: Oct. 1, 2013).

A double-blind, randomized, placebo-controlled, 12-week study was conducted on 102 peri- and menopausal women between 42 and 60 years of age with mild to moderate menopause symptoms. Reference: Kuznetsova I.V. UYB, Borisova N.I., Zhukova E.V., Berdnikova N.G., Gusak Yu.K. Akusherstvo i ginekologiya/Obstetrics and Gynecology. Efficiency of alternative therapy in perimenopausal and postmenopausal women (in Russian). Akusherstvo i ginekologiya/Obstetrics and Gynecology. 2016 5:126 – 33.

A review article is published discussing many studies on the roles of the hypothalamus and succinate in aging processes. Reference: Chen, T. T., Maevsky, E. I., & Uchitel, M. L. (2015). Maintenance of homeostasis in the aging hypothalamus: the central and peripheral roles of succinate. Frontiers in endocrinology, 6.

A double-blind, randomized, placebo-controlled, 12-week study was conducted on 125 peri- and menopausal women of 42–60 years of age with mild to moderate menopause symptoms. The manuscript of the results is being prepared for publication.