Ph.D Nutraceuticals M-2
Natural Gonadotropin Agonist!
Clinically Proven to
Increase
- Luteinizing Hormone (which directly
increases Total Testosterone)
- Follicle Stimulating Hormone
- Free Testosterone
- Vascular Blood Flow
- Strength
- Erectile Function
Directions: For optional results take 1
liquid Capsule daily for 30 days. Do not take more then the recomended dosage.
M-2
must be taken continually for clinical effectiveness which is cumulative. Many
notice the effects within 1 week of use.
Ingredients:
- 250mg Tribulus Terrestris 37:1*,
Equivalent to 9250mg Tribulus
- 150mg Epimedium 45:1*, Equivalent
to 6750mg Epimedium
- 20mg Cassia Oil
Non-Medicinal Ingredients:
- Soyabean Oil, Lecithin, Beeswax,
Gelatin, Purified Water, Caramel Color
Optimal Dosing:
- Take capsule on a regular timed schedule in the
morning or before bed.
Men will notice a significant increase
in semen ejaculate within the first week of use. Some have reported an increase
in aggression. Discontinue treatment if this becomes a concern.
Enhanced Athletes will also notice the
same increase in semen ejaculate similar to that of Clomid (Clomidifene
Citrate).
M-2 Effective Cycles
The Patent Pending process liquifies the
standardized active Ingredients making them completely Bio-available,
Hydrophilic and Biologically Active.
*An agonist is
a chemical that binds to a receptor of a cell and triggers a response by that
cell. Agonists often mimic the action of a naturally occurring substance.
Whereas an agonist causes an action, an antagonist blocks the action of the
agonist and an inverse agonist causes an action opposite to that of the agonist.
*Drug Extraction Ratio.
M-2 Natural Gonadotropin Agonist Clinical
Studies
REPORT ON THERAPY TO TREAT MALE SEXUAL
DYSFUNCTION
Orsini F., Ferretti V., Villani S.
University of Studies, Pavia, Department of Applied Health and
Psycho-behavioural Sciences, Internal Report
Improvement of the sexual dysfunction was measured using
the International Index of Erectile Function (IIEF), administered at baseline
and following a one-month treatment.
ERECTILE FUNCTION
a mean and median increase was observed in the scores of all the
questions, as well as in the score of the relevant sub-scale (Figure 1). The
difference from baseline values was found to be statistically significant in all
cases. The considerable decrease in the rate of patients affected by serious and
moderate erectile dysfunction and the increase in the rate of patients without
any erectile dysfunction bear witness to the general improvement of the erectile
function, which had already been highlighted by the overall score of the
sub-scale.
ORGASM
An increase was observed in the mean and median scores resulting from
the questions on ejaculation rate following sexual stimulation (Q 9) and the
feeling of orgasm following sexual stimulation (Q 10), but the variation is
significant only in the latter case (Table 3). On the whole, however, the mean
score of the orgasmic function increased significantly (p = 0.0117) following
one-month treatment,
SEXUAL DESIRE
An increase was observed in the mean and median scores resulting from
both the question on the feeling of sexual desire (Q 11) and the question
investigating the rate of sexual desire Internal report 7
(Q 12) (Table 4), with a consequent increase in the overall score of the sexual
desire area sub-scale (Fig. 4).
SATISFACTION DURING THE SEXUAL INTERCOURSE
Table 5 shows an increase in the mean and median values of all the
three items in the area of satisfaction during the sexual intercourse, and,
again, the increase is statistically significant (Table 5). In the same way, the
overall score of the sub-scale of satisfaction during the sexual intercourse
increases (Fig. 5) in a statistically significant manner (Table 5) over the
baseline values following one-month treatment.
GENERAL WELLBEING
The mean and median scores of both individual questions and general
wellbeing sub-scale increased significantly following one-month treatment (Table
6).
GENERAL COMMENT
The results highlight an overall improvement of the sexual dysfunctions of the
14 patients enrolled in the trial. A statistically significant improvement was
observed with regard to erectile function, orgasm, satisfaction during the
sexual intercourse and general wellbeing, while, in spite of a higher sexual
desire score in the IIEF sub-scale, it cannot be concluded that the difference
from baseline values is statistically significant.
In other words, the therapy seems to be:
- effective on erectile dysfunction;
- effective on the orgasmic function;
- effective on the degree of satisfaction during the
sexual intercourse;
- effective on wellbeing.
Tribulus used in M-2 is Tribestan
The experimental data from Tribestan administration have
been clinically confirmed so far by three groups of researchers: by the Higher
Military Medical Institute under the guidance of Prof. I. Viktorov,
Corresponding Member of the Bulgarian Academy of Sciences; by the Medical
University of Sofia; State University Hospital of Endocrinology, Gerontology and
Geriatry, under the guidance of Prof. E. Bozadzhieva, and by the National
Institute of Obstetrics and Gynecology - under the guidance of Prof. M. Protich.
The studies were carried on 212 male individuals, aged
between 14 and 60 years. The therapeutic properties of Tribestan were studied in
patients with partial or complete impotence. Both the tolerance and the adverse
effects of the product were studied. The studies were carried out by the method
of simple blind experiment, using placebo. In nozological terms, the studies
covered various types of male impotence: idiopathic oligoasthenozoospermia - 39
patients, resection of the left internal testicular vein in varicocele, with
subsequent oligoasthenozoospermia - 50 patients; inflammatory process of the
prostate with oligo- and azoospermia - 53 patients, primary and secondary male
hypogonadism - 20 patients, impotentia coeundi - 50 patients. The product was
individually administered to all patients who had not received hormonal agents
for at least one month prior to the treatment.
Results
Significant changes in spermatozoon motility were found
after Tribestan intake for 60 days (with a daily dose of 3 filmtablets) by males
with idiopathic oligoasthenozoospermia. The number of spermatozoa with normal
motility, as well as the mean motility rate, were increased.
The percentage of the motile spermatozoa was 29, on the
average, prior to the treatment and reached up to 36.66 after the treatment (p <
0.005). The mean motility rate of spermatozoa prior to the treatment was 1.95
mm/sec, after the treatment - 3.63 respectively (p < 0.001). No changes were
observed in the ejaculate volume. In both cases (before and after treatment) the
ejaculate volume was within the limits of the norm, about 4 ml on the average.
The number of spermatozoa in the treated patients was higher by 3 ml/ml
ejaculate on the average. In some cases, normalization of the spermogram
occurred during repeated treatment with a daily dose of 6 tablets. In these
cases, the improvement of the spermogram (normalization of the increased
viscosity, increased ejaculate volume, increased concentration and accelerated
motility of the spermatozoa) was accompanied be elevation of the serum levels of
the lutenizing hormone and testosterone, and reduction of the estradiol level.
The clinical comparison of the results from the
treatment with provirone of patients with idiopathic azoospermia and after
Tribestan administration revealed a favorable effect on three of the patients
(out of 6), unsuccessfully treated with provirone for a long period of time. The
results in the patients with varicocele and oligoasthenozoospermia as regards
the motility of the spermatozoa were identical in the reports of all research
teams, regardless of the differences in the doses and duration of the treatment.
Protich et al. found an average of 26.88% motile spermatozoa prior to the
treatment and after 60-day course with a dose of 1 tablet, three times daily -
39% (p < 0.02) with a mean motility rate of spermatozoa 2.06 mm/sec prior to the
treatment and 4.44 mm/sec post treatment respectively. No change in the
ejaculate volume was found. The other team (Victorov at al.) observed more
pronounced changes in the ejaculate volume after 90-day treatment with a daily
dose of 1.5 g (4.5 ml compared to 1 - 2 ml prior to the treatment, i.e. an
average of 1.55 ml of ejaculate volume in all patients). The number of
spermatozoa in 1 ml reached the values in 100% of the patients treated. The mean
percentage of motile spermatozoa prior to the treatment was 2.06 and was
increased to 33.09 (Tables 1,2,3).
Table 1. Results of Tribestan treatment (1 tablet 3
times daily for 60 days) of 38 males with idiopathic oligoasthenozoospermia
(represented in mean values) Indices Before treatment After treatment
a. Concentration of spermatozoa, million/ml 22.97 26.66
b. Motility, % 29.00 35.66*
c. Motility rate, mm/sec. 1.95 3.76*
Table 2. Results of Tribestan treatment (1 tablet 3
times daily for 60 days) of 16 males after varicocele operation with existing
oligoasthenozoospermia Indices Before treatment After treatment
a. Concentration of spermatozoa, million/ml 21.31 26.75
b. Motility, % 11.53 39.06*
c. Motility rate, mm/sec. 2.00 4.44*
Table 3. Results of Tribestan treatment (2 tablets 3
times daily for 90 days) of 36 males after varicocele operation and existing
oligoasthenozoospermia Indices Before treatment After treatment
a. Concentration of spermatozoa, million/ml 40.60 76.00*
b. Motility, % 3.05 33.09*
c. Motility rate, mm/sec. 2.06 4.44*
*The data are statistically significant.
The results of Tribestan administration to patients with
unilateral or bilateral hypothrophy of the testes and azoospermia deserve
particular attention. The patients complained of a sense of heaviness and
distention, as well as of a slight pain in the testes between 40th and 60th day
after the start of the treatment with a daily dose of 6 tablets. Upon
examination, a slight pain in the testes occurred upon palpation, as well as a
slight swelling, with no other evidence of pathological changes. Improvement
both as regards the ejaculate volume and the concentration and motility of the
spermatozoa was observed towards the end of the treatment. The testosterone
serum level was elevated from 1.75 mg/ml to 3.75 mg/ml. The pain in the
testicular region upon palpation abated within 2 - 3 months after treatment.
Tribestan administration to patients with chronic inflammatory process of the
prostate and disorders in the spermogram led to insignificant changes in these
cases when the inflammatory process had been treated previously.
No changes were found in patients with chronic
inflammation of the prostate (not treated previously). Out of 14 patients with
reduced libido and absence of pathology in the male genital organs, treated for
30-days (daily dose - 2 tablets, three times), 12 manifested obvious improvement
of the libido, one patient - a slight improvement (after a 60-day treatment
cycle) and no effect was observed in another one. Out of a total of 36 patients
with chronic prostatitis and reduced libido, 15 were very favorably affected by
the end of the treatment cycle (a total dose of 90 - 100 g), 12 - favorably, and
in 9 of the cases with a duration of the inflammatory process over 5 years, no
effect occurred. The patients with hypotrophy of the testes and idiopathic
azoospermia had no complaints as regards the libido, but in the course of the
treatment aimed at improving the spermogram an apparent libido enhancement was
recorded. Out of 9 patients treated for one of the gravest forms of male
hypogonadism (Klinefelter's syndrome, due to chromosomal anomalies), the libido
was enhanced in three of the patients, erection was reported in two and sexual
intercourse and masturbation were reported in another two patients. Elevated
levels of lutenizing hormone after the treatment were found in these patients.
The levels of the remaining sexual hormones and cholesterol were reduced. Two of
the patients with secondary insufficiency of sexual glands (Noonan's syndrome)
attained improvement of the libido and erections during the treatment. The
self-confidence was improved in one of them, and in the second - hair grew in
the male genital region.
The results of the treatment of three patients with
cryptorchidism (one of them with uncorrected malformation) comprised improvement
of the libido and often masturbation. The duration of the erection was prolonged
in one patient from that group, aged 37. The spermogram of the same patient was
significantly better compared to the initial status one month after treatment,
i.e. on day 90 ftehr the beginning. One patient with secondary hypogonadism
reported hair growing in the axillary and genital region, parallel with enhanced
libido and frequent masturbation.
The serum testosterone levels were elevated in 20
patients from various nozological groups, the initial and final values being
within the norm. In seven patients with testosterone serum level below the lower
limit of the norm, the physiological levels were reached after the treatment,
whereas in the rest of the patients with normal initial levels, the testosterone
was not significantly changed after treatment.
Tolerance and side effects
All clinicians engaged in the studies reported a very
good tolerance and no drug-related side effects. The clinical laboratory data on
Tribestan treated males showed no deviations in the blood count, ESR,
flocculation tests and urine.
Discussion of the results
The clinical studies of all three research teams on a
total of 212 patients (males with disorders in the sexual function) confirmed
the experimental data on a pronounced stimulating effect of the new Bulgarian
phytochemical preparation on the sexual functions. It restored and improved the
libido in all forms of impotentia coeundi after the administration of a mean
daily dose of 1.5 g for 30 - 40 days. This suggests that not only the diminished
libido was stimulated, but also that a therapeutic effect on both primary and
secondary male hypogonadism was present. The assumption that the product was a
favorable effect on spermatozoa motility after 60-day administration corresponds
to the experimental data, according to which it stimulates both the mitosis and
maturation of the germinal cells.
It is well known that at least 80 days elapse from the
time of the division of the spermatogonia till the formation of a mature
spermatozoon in males, hence the concentrations of the spermatozoa in the semen
are different within that period. The team that used a therapeutic course of 90
days observed very good results in terms of both the motility and the
concentration of the spermatozoa in the ejaculate. The studies of ejaculate from
patients receiving the product for 60 days proved its apparent effect on the
motility of the spermatozoa and an insignificant effect on their concentration
on the basis of identical initial spermatozoal levels, as well as the presence
of identity in the nozological groups prior to the treatment. This confirms the
fact that the minimum therapeutic cycle should last at least as long as one
complete germinal cycle (i.e. 80 - 90 days in males). Both idiopathic oligo- and
azoospermia are diseases with so far undistinguished etiology. The serum levels
of sex steroids are not changed in the majority of the patients with such
deviations and good therapeutic levels of the product are observed. No data are
available from testes biopsy that can throw light as to which of the phases of
this complicated process of spermatogenesis has been affected pathologically and
hence favorably affected by the product. Kumanov at al. advanced the hypothesis
of diminished central effect of the product, associated with its mechanism of
action, based on the elevated level of the lutenizing hormone. On the other
hand, they admitted the existence of a peripheral effect, which could be
responsible for the effect of the product on hair growth.
The reduced level of serum cholesterol under the effect
of the product provided grounds for the same authors to assume that it also had
an effect of cholesterol metabolism. The mechanism of action of Tribestan has
not been elucidated so far. It can be concluded, on the basis of the clinical
studies carried out so far, that it has a very good stimulating and therapeutic
effect in all forms of impotentia coeundi, as well as a very good therapeutic
effect in patients with oligoasthenospermia. The product has a very good
tolerance and no undesired side effects. Based on the date presented so far, we
recommend Tribestan for the treatment of impotentia coeundi and generaldi, due
to oligospermia and diminished motility of spermatozoa.
M-2 Clinical Study - pending publication
The extracts of Tribulus induces synthesis of
testosterone, a hormone responsible for stimulating sexual desire in both men
and women. The extract of Epimedium Koreanum, which is rich in crenelated
flavonoids, has a vasodilating effect mediated by NO release, so that the
extract performs a vasokinetic activity on the arteries and arterioles. The
extract of Cinnamon cassia indirectly stimulates the libido by acting on the
pleasure-related dopamine receptors.
Biochemical studies have demonstrated the great
complexity of the mechanisms involved in the physiological processes associated
with sexual activity, such as penile and clitoral erection, vaginal lubrication,
ejaculation and orgasm. Mediators such as nitric oxide (NO) , the enzyme factors
involved in the metabolism of the cAMP and cGMP messengers, the adrenergic
receptors of the smooth muscle cell membranes, dopaninergic neurotransmitters,
and the receptors of PGs or other hormones are the possible targets of a
pharmacological treatment for impotence and other sexual dysfunctions.
The therapeutic results obtainable with the compositions
of each standardized extract are associated in quantitive rations different from
those stated above. The real increase in sexual activity can therefor only be
found when the extracts are of the various plants in a precise ratio which
increases both libido and the blood supply to the genital organs.
Chronic administration of the compositions do not cause
any significant side effects, is well tolerated, and does not alter the delicate
hormone balances, especially the androgen/oestrogen balance, which govern major
physiological events in men and women such as aeropause and menopause
Precipitation of the active principles in aprotic
solvents allows to remove undesired inert substances and to concentrate the
active principles.
The extracts of Tribulus and Epimedium are further
enriched in active principles by back-extraction of the concentrated aqueous
extracts with water-immiscible solvents, which extract with sufficiency
selectively either the flavonoids or the saponins respectively.
