Safety 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. |
» View Abstract
» Request a reprint |
| Imhof M et al. 56 |
Maturitas 2006
In Press |
Effects of a red clover extract (MF11RCE) on endometrium and sex hormones in postmenopausal women. |
» Request a reprint |
| Atkinson et al. 8 |
Breast Cancer Research
2004; 6:R170-R179 |
Red clover-derived isoflavones and mammographic breast density: a double blind, randomized, placebo-controlled trial |
» Request a reprint |
| 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. |
» View Abstract
» Request a reprint |
| 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. |
» View Abstract
» Request a reprint |
| Baber R et al. 10 |
Climacteric 1999; 2:85-92. |
Randomized placebo-controlled trial of an isoflavone supplement and menopausal symptoms in women. |
» View Abstract
» Request a reprint |
|
» Go to Full Reference List |
