Promensil Clinical Studies

PROMENSIL Product Specific Clinical Trials:

(Over half a BILLION daily doses of Promensil have been sold since 1998)

“(Statistics show that more than 73% of doctors in the UK prescribe Promensil as the alternative for HRT”

(See Studies listed at the bottom according to reference numbers)

Vasomotor Symptom Relief:

  • Four randomised,double blind placebo-controlled studies evaluating the use of red clover isoflavones in the treatment of vasomotor symptoms have been published. In addition two open-label trials and two Meta Analyses have also been conducted and published. (5,6,7,8,9,10)
  • Latest Randomised Double Blind Placebo controlled study. (25) Significant average decrease of 74% in daily hot flush night sweat frequency was achieved in the red clover groups. Red Clover 80mg used in study – Promensil Double Strength.

Cardiovascular Support:

  • Improved Systemic Arterial Compliance.(11)
  • Reduction in Arterial Stiffness.(12)
  • Effect on Lipids in post menopausal women.(13)
 Bone Support:
  • The effects of phytoestrogen isoflavones on bone density in women. A double-blind, randomized, placebo-controlled trial. (14)
  • The effect of isoflavones extracted from red clover on lipid and bone metabolism. (15)
  • Significant improvement  ( up to 4.1% ) in proximal forearm bone density over 6 months in post menopausal women. – Randomised double blind, placebo controlled.

Para Climacteric Effects:

  • RED CLOVER EXTRACT (PROMENSIL DOUBLE STRENGTH) exerted a subject improvement of SCALP. HAIR & SKIN status as well as LIBIDO,MOOD,SLEEP & TIREDNESS in post menopausal women. (26)

Anxiety & Depression:

  • Symptoms of anxiety & depression were reduced by 76.9% in the total HADS score (Hospital Anxiety & Depression Scale) & 80.6% in the total SDS score (Zung’s self rating depression scale).
  • These results were significant – Randomised double blind, placebo controlled. (27)

SAFETY

Breast Safety:

  • A double-blind randomized controlled trial of isoflavones in the treatment of cyclical mastalgia. (16). Reducton in cyclical mastalgia of 44% compared to 13% for placebo in two menstrual cycles.
  • Red clover-derived isoflavones and mammographic breast density: a double-blind. randomized, placebo-controlled trial. (17). No oestrogenic increase in breast density seen over 3 years when red clover isoflavones  (Promensil*)  taken by  women with a 1st degree relative with breast cancer.
  • Red clover isoflavones are safe and well tolerated in women with a family history of breast cancer(18)

Endometrial Safety:

  • Red clover isoflavones are safe and well tolerated in women with a family history of breast cancer. (19)
  • Endometrial thickness & FSH measured. Significant decrease of 14.7% in endometrial thickness in  post menopausal women
  • Effect of red clover isoflavones (Promensil) versus placebo on uterine endometrium, vaginal maturation index and the uterine artery in healthy postmenopausal women. (20)
  • After 12 weeks dosing with 50 mg red clover isoflavone concentrate. There was no change in proliferative index compared to a placebo group. (21)
  • No increase in endometrial thickness measured by Doppler ultrasonography was observed in Promensil or placebo and no difference was observed between groups for uterine blood flow. (22)
  • After 12 weeks dosing at 40 mg per day. There was no change in the endometrial thickness of the uterus from baseline measures. (23)

Product Related Side Effects:

  • There have been no product related adverse safety endpoints to date (Launched in 1997) Promensil is sold in 24 countries & has prescription status in Brazil.

Legislatory Status:

  • MBR 20.8 – Status Ref no’s: Promensil Menopause 40mg – 140973 Promensil Double Strength 80mg – 132817.
  • Dossier will be handed in during 2015 for registration as a Category D Complimentary medicine – Medicines and Related Substances Act, 1965 (Act 101 /1965) – Nov.2013.

 

REFERENCES

1)    Kimira M,Arai'(, Shimos K &Watanbe S.Japanese intake of Flavonoids and lsoflavonoids from foods. J Epideniol 1998;8(3):168-75.

2)    Couse JF. Lindzey J, G Randien K.Gustafsson JA, Koradi KS.Tissue Distribution and Quantitative analysis of Estrogen Receptor Alpha and Estrogen Receptor Beta. Endocrinol 1997; 138(11): 64613-21.

3)    Collins BM, Mclachlan JA, Arnold SF. The Estrogenic and Anti Estrogenic Activities of Phytochemicals with the human Estrogen Receptor expressed in Yeast. Steroids 1997;62(4): 363-72.

4)   Price PR, Fenwick GR. Naturally occurring oestrogens in foods – A review. Food Addit. Contaml 985; 2(2): 73-106.

5)   Van de Weijer PflM,Barentsen R.lsoflavones from red clover {Promensil) significantly reduce menopausal hot flush symptoms compared with placebo. Maturitas 2002, 42:187-193.

6) Jeri AR.The use of an isoflavones supplement to relieve hot flushes. The female Patient 2002; 27:35-37.

7)   Hildalgo LA.Chedraui PA. Morocho N,Ross S.Miguel GS. The effect of red clover isoflavones on menopausal symptoms,  lipid and vaginal cytology in menopausal women: A randomised, double-blind, placebo-controlled study. Gynecological Endocrinology 2005;21(5):257-264.

8)  Nachtigall LB, Fenichel R, La Grega L,Wei Lee W,Nachtigall L. The effect of isoflavone derived from red clover on vasomotor symptoms, endometrial thickness, and reproductive hormone concentrations fn menopausal women. 81st Annual Meeting of the Endocrine  Society. The Endocrine Society 1999.

9)  Howes LG, Howes JB,Knight DC. lsoflavone therapy for menopausal flushes. A systematic review and meta-analysis. Maturitas 2006;55(3): 203-11.

10) Thompson Coon J, Pittler MH, Ernst E. Trifolium pratense isoflavones in the treatment of menopausal hot flushes:A systematic review and meta-analysis. Phyto medicine 2007;14:153-159.

11)  Nestel PJ.Pomeroy S,KayS. Komesaroff P,BehrsingJ,Cameron JD,West L Isoflavones from red clover improve systemic arterial compliance but not plasma lipids in menopausal women. J ClinEndo Metab 1999;84(3):895-898.

12) Teede 1-ll, McGrath BP, De Silva L, Cehun M, FassoulakisA, Nestel PJ. lsoflavones reduce arterial stiffness.A placebo controlled study in men and postmenopausal women. Arterioscler Thromb Vase Biol2003;23(6): 1066-71.

13) Jeri A.  Effects of isoflavone phyto estrogens  on lipid profile in postmenopausal  Peruvian women. 10th World Congress on the Menopause 2002. Berlin,Germany.

14)       Atkinson C. Compston JE, Day NE, Dowsett M, Bingham SA. The effects of phyto estrogen isoflavones on bone density in women: a double blind, randomised, placebo controlled trial. Am J Clin Nutr 2004;79:326-33.

15)        Clifton-Bl gh PB, Baber RJ, Fulcher GR, Nery MLMoretonT. The effect of isoflavones extracted from red clover (Rismostil) on lipid and bone metabolism. J. NorthAmer Meno Society,2001,8(4):259-265.

16)       Ingram DM,Hickling c, West L, Mahe LJ, Dunbar PM. A double blind randomised controlled trial of isoflavones in the treatment of cyclical mastalgia. The Breast 2001.

17)       Atkinson C, Waren RML Sala E. Dowsett M. Dunning AM. Healey CS,Runswidc S. Day NE, Bingham SA. Red Clover derived isoflavones and mammographic breast density: a double blind, randomised, placebo-controlled trial. Br Cancer Res 2004; 6(3): Rl70- Rl79.

18)       Powles TJ,HowellA. Gareth Evans D,McCloskey EV. Ashley S,Greenhalgh R,Affen J,Flook LA, Tidy A. Red clover isoflavones are safe and well tolerated in women with a family history of breast cancer. Meno Inter 2008; 14:6-12.

19)       Powles TJ,HowellA. Gareth Evans D, Mccloskey EV. Ashley S.G Greenhalgh R, Affen J,Flook LA, Tidy A. Red clover isoflavones are safe and well tolerated in women with a family history of breast cancer: Meno lnter2008; 14:6-12.

20)        Woods R, Colville N, Blazquez, Cooper A. Whitehead MI. Effects of red clover isoflavones (Promensil) versus placebo on uterine endometrium, vaginal maturation index and the uterine artery in healthy postmenopausal women. Brist Meno Annual Conference Manchester, UK2003.

21)         Hale GE, Hughes CL, Robboy SJ,Agarwal SK and Bievre M. A double-blind randomized study on the effects of red clover isoflavones on the endometrium. Menopause 2001; 8(5):338-46.

22)        Woods R, Colville N,Blazquez J, Cooper A, Whitehead Ml,Effects of red clover isoflavones (Promensil) versus placebo on uterine endometrium, vaginal maturation index and the uterine artery in health postmenopausal women. Journal of the British Menopause Society 2003; 52:23.

23)        Baber R, Moreton T,Kelly G and West L. Randomized placebo controlled trial of an isoflavone supplement and menopausal symptoms in Women. Climacteric 1999;2:85-92.

24)        Nachtigall LE, Baber RJ, Barentsen R. Durand N, Panay N, Pitkin J,van de Weijer PHM, Wysocki S. Complementary and hormonal therapy for vasomotor symptom relief. A conservative clinical approach. J Obster and Gynecology 2006, 27289.

25)     The effect of red clover isoflavone supplementation over vasomotor & menopausal symptoms in postmenopausal women Markus Lipovac etal- Gynecological Endocrinology 2011,1-5.

26)     The Effect of Red Clover lsoflavones (Promensil Double Strength) over skin, appendages & mucosal  status  in Post  Menopausal Women.  Mar1cus  Lipovac et Al.  Obst  & Gynecology International Vol 2011.6 pages ie 10.1155120111949302.

27)     Improvement of post menopausal depressive & anxiety symptoms after treatment with isoflavones derived from red clover 80mg (Promensil Double Strength) Lipovac M,Chedraui P, GruenhutC, GocanA Stammieretal:Maturitas 65 (2010)258-264.