Clinical Studies

Clinically Tested & Published in Peer-Reviewed Journals

Over the last decades, women's lifespan has increased, and more women experience a greater part of their lives in menopause. Menopause is not a disease, but is the result of a physiological transition that can be scientifically evaluated to determine the statistical likelihood that an response to intervention helps alleviate bothersome symptomology, including hormonal and non-hormonal regimens. Amberen is one such intervention that has been clinically tested and is shown with statistical significance to provide women with relief of up to 12 symptoms.

Thankfully, a variety of improvements in overall healthcare allows women to maintain a healthy and desirable lifestyle during and after the onset of menopause.

As a medical professional, you are a woman's most trusted advisor when it comes to choosing an appropriate form of menopause relief. Should your patients prefer to take a non-prescription route, we appreciate your consideration of Amberen - a safe and effective clinically tested alternative for their menopause symptom relief.

Amberen Clinical Trials

The scientific foundation that supports Amberen's effectiveness and safety includes three randomized, double-blind, placebo-controlled clinical studies on menopausal and perimenopausal women in addition to over 45 years of research on its main ingredient, succinates.

2015-2016: Randomized, double-blind placebo-controlled 12-week clinical study on 125 peri- and menopausal women 42-60 years of age with mild to moderate menopause symptoms (STRAW+ 10 classifications).

2014-2015: Randomized, double-blind placebo-controlled 12-week clinical study on 102 peri- and menopausal women 42-60 years of age with mild to moderate menopause symptoms.

Methods:

Baseline and monthly assessments:

  • 1.  Menopause symptoms (the Green Climacteric Scale)
  • 2.  Anxiety (the Spielberger-Hanin scale)
  • 3.  Estradiol, FSH, LH

The studies were conducted in accordance with Good Clinical Practice and followed all international standards of trials involving human subjects.

2001: Randomized, double-blind placebo-controlled 3-week clinical study on 70 menopausal women.

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) Gynecological Endocrinology, 32:sup2, 64-68, DOI: 10.1080/09513590.2016.1232686

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

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.

Results:

Results* from 2016 clinical trial

  • Difficulty sleeping – 87% of women reported less difficulty sleeping
  • Hot flashes – 91% of women reported reduction in hot flashes
  • Night sweats – 78% of women reduction in night sweats
  • Irritability – 85% of women reported reduction in irritability
  • Mood swings – 80% of women reported symptom reduction
  • Energy – 77% of women reported improvement in their energy
  • Sex drive – 73% of women reported improvement in their sex drive
  • Headaches – 71% of women reported headache relief
  • Muscle and joint pain – 74% of women reported muscle and joint pain relief
  • Difficulty concentrating – 82% of women say this symptom improved
  • Increased excitability – 63% of women reported relief of this symptom

Hot flashes relief: 91% of women who took Amberen for 90 days reported reduction in hot flashes

Baseline

End of the trial

Anxiety relief

According to the Spielberger-Hanin scale used to determine Amberen's effect on anxiety levels, there was a statistically significant decrease in all types of anxiety in the Amberen group:

  • Situational anxiety from -0.77 to -8.0
  • Personal anxiety from 14.72 to 4.0
  • Actual anxiety from 48.98 to 30

Summary: high anxiety level in the Amberen group at the beginning of the clinical trial equal to actual anxiety above 45, dropped to low levels by the end of the studies equal to actual anxiety below 31.

Estradiol

Plasma estradiol levels showed statistically significant increase after 90-day supplementation with Amberen. Note that FSH and LH levels have decreased over the course of 90 days.

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