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Efficacy
To date, over 1,000 women have participated in clinical trials with Promensil Menopause. All studies were conducted by specialists in universities and teaching hospitals under strict ethical approval using Good Clinical Research Practise guidelines.
Promensil Menopause has been clinically tested and studies show that Promensil's red clover isoflavones have the potential to:
Help manage the symptoms of menopause 1-4
Help relieve hot flushes
Help relieve night sweats
May help reduce bone loss in lumber spine 5
May help maintain cardiovascular health.6
Increase superficial cells in the vagina; an indicator for reducing vaginal atrophy.7
In addition, Promensil Menopause clinical trials have investigated safety parameters. The results of these trials were:
No increase in breast density. 8
No increase in endometrial thickening.9,10
No change in biochemical and haematological parameters 11 (including liver function) 9 .
Promensil is well-tolerated in healthy women. 59
More detail on Promensil safety studies can be found under Safety and Tolerability
Clinical Trials conducted with Promensil
The following papers have been published in peer-reviewed journals, or presented at scientific conferences:
Menopause Symptoms
Panay.57 |
Maturitas 57 (2007); 90-94. |
Integrating phytoestrogens with prescription medicines – A conservative clinical approach to vasomotor symptom management |
|
Thompson Coon J, Pittler MH, Ernst E |
Phytomedicine 2007 |
Trifolium Pratense isoflavones in the treatment of menopausal hot flushes: A systematic review and meta-analysis. |
|
Howes LG, Howes JB and Knight DC 53 |
Maturitas 2006 |
Isoflavone Therapy for menopausal flushes: A systematic review and meta-analysis. |
|
Hidalgo LA et al. 55 |
Gynecol Endocrinol |
The effect of red clover isoflavones on menopausal symptoms, lipids and vaginal cytology in menopausal women: A randomised, double-blind, placebo-controlled study. |
|
Van de Weijer, P and Barentsen, R 2 |
Maturitas 2002; 42 (3): 187-193. |
Isoflavones from red clover (Promensil) significantly reduce menopausal hot flush symptoms compared to placebo. |
|
Jeri, A 1 |
The Female Patient 2002; 27:35-37. |
The use of an isoflavones supplement to relieve hot flushes. |
|
Nachtigall LB, et al. 3 |
The Female Patient 1999; 24:45-50. |
Nonprescription alternatives to hormone replacement therapy |
|
Baber R et al. 10 |
Climacteric 1999; 2:85-92. |
Randomized placebo-controlled trial of an isoflavone supplement and menopausal symptoms in women. |
|
Knight D, Howes J, and Eden J. 11 |
Climacteric 1999; 2: 79-84 |
The effect of Promensil, an isoflavone extract, on menopausal symptoms. |
|
Tice et al. 12 |
JAMA. 2003 Jul 9;290(2):207-14 |
Phytoestrogen supplements for the treatment of hot flashes: the Isoflavone Clover Extract (ICE) Study: a randomized controlled trial. |
|
Atkinson C, Warren RML, Sala E, Dowsett M, Dunning AM, Healey CS, Runswick S, Day NE, Bingham SA. 8 |
Research 2004; 6:R170-R179. |
Red clover-derived isoflavones and mammographic breast density: a double blind, randomised, placebo-controlled trial. Breast Cancer |
|
Hale GE, Hughes CL, Robboy SJ, Agarwal SK, and Bievre M. 9 |
Menopause 2001; 8 (5): 338-46. |
A double-blind randomized study on the effects of red clover isoflavones on the endometrium. |
Bone Effects
Atkinson C et al. 5 |
Am J Clin Nutr 79 (2): 326-33. |
The effects of phytoestrogen isoflavones on bone density in women: a double-blind, randomized, placebo-controlled trial |
|
In Vitro Study: Muir M, Siva D, Dai D, Mason R. 13 |
Presented at Australasian Menopause Society Meeting, Sydney, 2002. |
Isoflavones enhance human osteoblast proliferation, activity and lifespan in vitro |
Cardiovascular Effects
Jeri A. 6 |
Presented at the 10th World Congress on the Menopause, Berlin, 2002. |
Effects of isoflavone phytoestrogens on lipid profile in postmenopausal Peruvian women |
|
Nestel P et al. 14 |
J Clin Endocrinol Metab 1999. 84(3): 895-898 |
Isoflavones from red clover improve systemic arterial compliance but not plasma lipids in menopausal women |
|
Knudson Schult T et al. 15 |
Maturitas 2004 48 |
Effect of isoflavones on lipids and bone turnover markers in menopausal women. |
Vaginal Effects
Woods R et al. 7 |
Journal of the British Menopause Society 2003. S2: 23. |
Effects of red clover isoflavones (Promensil) versus placebo on uterine endometrium, vaginal maturation index and the uterine artery in healthy postmenopausal women |
Back to TopSafety and Tolerability
Clinical trial safety data
Over 1,000 women have been enrolled in Promensil clinical trials.
To date, there have been no severe or life-threatening reactions to Promensil.
All completed studies with analysed safety information are summarised in Table 1. All events collected through the clinical trial program were considered non-serious and not related to the study product by the investigator. There were no abnormal laboratory outliers in either the placebo or active treatment groups for the combined trial data.
During these trials, up to four tablets (160 mg isoflavones) of Promensil Menopause per day were well tolerated, and adverse events in both placebo and Promensil groups were considered to be unrelated to treatment11 . Indeed, migraine and arthralgia were reported more frequently in the placebo than the Promensil groups. This may be due to their classification as menopausal symptoms, for which placebo recipients were not receiving active treatment. In addition, no changes in haematological and biochemical parameters were observed, and there was no evidence of breakthrough bleeding. A study has also been performed to assess endometrial changes however there was no proliferative or antiproliferative effect measured by the immunohistochemical marker Ki-67. 9
To Summarize:
Pooled adverse event data showed no difference at different doses or each dose compared to placebo.
Pooled laboratory endpoints showed no difference in each group from baseline or by comparing each dose.
Consistent with the current knowledge of isoflavone consumption in humans. Food containing quantities of isoflavones at both of these doses are consumed in communities with no known adverse events.
The body of data regarding the safety of Promensil continues to grow, there has been significantly more data collected on the use of this product than for any other isoflavone-containing product.
Placebo
(n=379)40 mg
(n=277)80 mg
(n=225)160 mg
(n=31)Body site as whole
30 (7.9%)
26 (9.4%)
12(5.3%)
0
Central nervous system
43 (11.3%)
27 (9.7%)
8 (3.5%)
1 (3.2%)
Cardiovascular
5 (1.3%)
6 (2.2%)
1 (<1%)
0
Gastrointestinal
30 (7.9%)
23 (8.3%)
12 (5.3%)
3 (9.7%)
Musculoskeletal
47 (12.4%)
22 (7.9%)
19 (8.4%)
0
Respiratory system
21 (5.5%)
10 (3.6%)
13 (5.8%)
0
Thrombogenic
2 (<1%)
1 (<1%)
1 (<1%)
0
Genitourinary System
15 (4.0%)
5 (1.8%)
8 (3.5%)
3 (9.7%)
Total
202 (53%)
128 (46%)
83 (37%)
8 (26%)
Table 1. Percentage of patients with reported adverse events in placebo-controlled trials using 40, 80 or 160 mg of red clover isoflavone concentrate, grouped into body systems.
Relevant Studies
Powles et al. 59 |
Menopause International 2008; 14:6-12 |
Red clover isoflavones are safe and well tolerated in women with a family history of breast cancer. |
|
Imhof M et al. 56 |
Maturitas 2006 |
Effects of a red clover extract (MF11RCE) on endometrium and sex hormones in postmenopausal women. |
|
Atkinson et al. 8 |
Breast Cancer Research |
Red clover-derived isoflavones and mammographic breast density: a double blind, randomized, placebo-controlled trial |
|
Campbell et al.16 |
European Journal of Clinical Nutrition 2004; 58: 173-179. |
Effect of red clover-derived isoflavone supplementation on insulin-like growth factor, lipid and antioxidant status in healthy female volunteers: a pilot study. |
|
Hale et al.9 |
Menopause 2001; 8(5): 338-46. |
A double-blind randomized study on the effects of red clover isoflavones on the endometrium. |
|
Baber R et al. 10 |
Climacteric 1999; 2:85-92. |
Randomized placebo-controlled trial of an isoflavone supplement and menopausal symptoms in women. |
Quality
Novogen is a pharmaceutical company that adheres to the guidelines of Good Manufacturing Practice. Promensil Menopause is a standardised isoflavone supplement which contains the stated total isoflavone dose in the aglycone form in every tablet 21,22. The quality of the products is of the highest standard, with the production facility regularly audited by the Therapeutic Goods Administration.
Despite government regulations which control the components of alternative therapies, adherence to the stated amounts of the components is not routinely assessed 22. A comparison of phytoestrogen supplements available in the United States, including Promensil, found that half of the products tested had isoflavone levels that deviated by more than 10% from the claimed value. There was a large variability in the composition of supplements, as determined by HPLC profiles, many containing peaks of unknown origin and chemical structure 22. This study confirmed the quality and standardisation of the Promensil product.
A similar study compared some of the products available in Australia, including Promensil. While only two products had total isoflavone contents close to the stated amount, only Promensil was found to have constant isoflavone content for all batches tested.
Howes J and Howes L 21 |
Med J Aust 2002. 176 (3): 135-6 |
Content of isoflavone-containing preparations |
|
Setchell K et al. 22 |
J Nutr 2001. 131(4): 1362S-75S. |
Bioavailability of pure isoflavones in healthy humans and analysis of commercial soy isoflavone supplements |
