Femarelle

Flaxseed is one of the ingredients used in certain Femarelle formulations.

Femarelle is a dietary supplement range containing DT56a, a tofu-derived soy extract, together with additional ingredients including flaxseed powder, vitamins, and minerals.^[1] DT56a has been studied for its potential activity as a selective estrogen receptor modulator (SERM), meaning that it may interact selectively with estrogen receptors in different tissues.^[2][3]

Femarelle has been evaluated in several clinical studies investigating its possible role in supporting women during menopause, including studies on menopausal symptoms, vaginal health, bone health, and safety profile.^[2] Some studies reported encouraging findings, including improvements in menopausal symptoms and a favorable safety profile compared with traditional hormone replacement therapy, although the published trials were generally limited by relatively small sample sizes and short study durations.^[2]

In 2008, an application was submitted to the European Food Safety Authority (EFSA) regarding a health claim related to bone mineral density and osteoporosis risk.^[1] EFSA concluded that the available evidence at that time was insufficient to establish a cause-and-effect relationship between Femarelle consumption and improvements in bone mineral density or reduction of osteoporosis risk in postmenopausal women.^[1]

Product range

The Femarelle product range was developed to address the changing needs of women throughout different stages of menopause. Each formulation combines DT56a with selected vitamins, minerals, or botanical ingredients tailored to specific menopausal concerns.

Femarelle Recharge

Femarelle Recharge is intended for women experiencing common menopausal symptoms such as hot flashes, night sweats, sleep disturbances, and reduced quality of life during menopause. The formulation contains DT56a, flaxseed powder, and vitamin B6.

Femarelle Rejuvenate

Femarelle Rejuvenate is intended for women in the perimenopausal stage and focuses on symptoms associated with hormonal fluctuations, including mood changes, tiredness, and changes affecting skin and hair. The formulation contains DT56a together with biotin and riboflavin (vitamin B2).

Femarelle Unstoppable

Femarelle Unstoppable is designed for postmenopausal women, with a focus on bone health, muscle function, and overall wellbeing during later stages of menopause. The formulation contains DT56a, calcium, vitamin D3, biotin, and riboflavin (vitamin B2).

Mechanism of action

DT56a has been described in scientific literature as a selective estrogen receptor modulator (SERM)-like compound.^[4] Experimental studies have suggested that DT56a may exert agonistic effects on estrogen receptors in bone and brain tissues,^[5][6] while demonstrating limited activity in uterine and breast tissues.^[7][8]

Several studies have investigated DT56a in relation to menopausal symptoms and bone health.^[9][10] In vitro studies have also reported stimulation of osteoblast activity in cultured human bone cells.^[11]

Published studies have additionally suggested that DT56a does not significantly affect circulating hormone levels^[9] or blood coagulation parameters.^[12]

See also

• Selective estrogen receptor modulator

References

1. Poluzzi E, Piccinni C, Raschi E, Rampa A, Recanatini M, De Ponti F (2014). "Phytoestrogens in postmenopause: the state of the art from a chemical, pharmacological and regulatory perspective". Current Medicinal Chemistry. 21 (4): 417–436. doi:10.2174/09298673113206660297. PMC 3963458. PMID 24164197.
2. Bedell S, Nachtigall M, Naftolin F (2014). "The pros and cons of plant estrogens for menopause". Journal of Steroid Biochemistry and Molecular Biology. 139: 225–236. doi:10.1016/j.jsbmb.2012.12.004. PMID 23270754.
3. "Scientific Opinion of the Panel on Dietetic Products Nutrition and Allergies on a request from the Secure Pharmaceuticals Ltd on Femarelle® and bone mineral density". EFSA Journal. 785: 1–10. 2008. doi:10.2903/j.efsa.2008.785.
4. Somjen D, Katzburg S, Knoll E (2007). "DT56a (Femarelle): a natural selective estrogen receptor modulator (SERM)". Journal of Steroid Biochemistry and Molecular Biology. 104 (3–5): 252–258. doi:10.1016/j.jsbmb.2007.03.004. PMID 17428655.
5. Somjen D, Yoles I (2003). "DT56a (Tofupill/Femarelle) selectively stimulates creatine kinase specific activity in skeletal tissues of rats but not in the uterus". Journal of Steroid Biochemistry and Molecular Biology. 86 (1): 93–98. PMID 12943748.
6. Somjen D, Yoles I (2003). "DT56a stimulates creatine kinase specific activity in vascular tissues of rats". Journal of Endocrinological Investigation. 26 (10): 966–971. PMID 14759068.
7. Yoles I, Lilling G (2007). "Pharmacological doses of the natural phyto-SERM DT56a (Femarelle) have no effect on MCF-7 human breast cancer cell-line". European Journal of Obstetrics & Gynecology and Reproductive Biology. 130 (1): 140–141. doi:10.1016/j.ejogrb.2006.02.010. PMID 16580119.
8. Oropeza M, Orozco S, Ponce H, Campos M (2005). "Tofupill lacks peripheral estrogen-like actions in the rat reproductive tract". Reproductive Toxicology. 20 (2): 261–266. doi:10.1016/j.reprotox.2005.02.007. PMID 15878261.
9. Yoles I, Yogev Y, Frenkel Y, Hirsch M, Nahum R, Kaplan B (2004). "Efficacy and safety of standard versus low-dose Femarelle (DT56a) for the treatment of menopausal symptoms". Clinical and Experimental Obstetrics & Gynecology. 31 (2): 123–126. PMID 15266766.
10. Yoles I, Yogev Y, Frenkel Y, Nahum R, Hirsch M, Kaplan B (2003). "Tofupill/Femarelle (DT56a): a new phyto-selective estrogen receptor modulator-like substance for the treatment of postmenopausal bone loss". Menopause. 10 (6): 522–525. doi:10.1097/01.GME.0000064864.58809.77. PMID 14627860.
11. Somjen D, Katzburg S, Lieberherr M, Hendel D, Yoles I (2006). "DT56a stimulates gender-specific human cultured bone cells in vitro". Journal of Steroid Biochemistry and Molecular Biology. 98 (1): 90–96. doi:10.1016/j.jsbmb.2005.08.002. PMID 16243521.
12. Nachtigall L. SEG Paris 2007 Congress Book.