Group A
 Fifteen patients were treated by the first regimen, none of them showed any essential  changes in parameters determining the occurrence of
 ovulation. Moreover, there were noted some undesirable effects such as a longer menstruation cycle, excessive libido sexualis, related
 general excitability, insomnia, and in case of abrupt discontinuation of the drug intake at the end of the third month or even in reducing the
 dose by 50% only – a dramatic decrease of libido sexualis and general weakness. It made necessary to apply the second regimen to the
 remaining 36 patients – the date are down in the following figures and tables. The distribution of women treated with Tribulus is given on
 Figure 1. The prevailing number of them were in the age group 28 to 30 years old and only 2 were over 36 years of age. Nineteen patients
 were with primary hormonal infertility and 18 with secondary hormonal infertility, i.e. the number was almost equal, see Figure 2. The
 distribution of patients with regard to previous treatment is shown on Figure 3. One can note that those untreated previously were about
 36% of the women: others with prior hormonal or surgical correction of ovaries were of almost the same number – 20 to 30% and the
 smallest was the group with combined hormonal and surgical therapy. In Table 1 we show lower values of unsatisfactory treatment
 with Tribulus (33.3%) compared to Clostylbegit (52.4%) or Fertodur (76%). Undoubtedly best results were obtained with Stimovul
 normalized ovulation with subsequent pregnancy of 39%, normalized ovulation without resultant pregnancy of 35.5% and no effect of 26%.
 Tribulus has a considerably more moderate effect: 24 of the total number of 36 treated women had normalized ovulation but only in 2 of
 them was followed by pregnancy and in 12 patients it had no basic effect. Twenty women were treated simultaneously with Tribulus and an
 ovulation stimulant. The effect from their combined use was better compared to treatment with single agents. Probably here there is a
 complex effect – hormonal stimulation of ovulation is combined with increased libido sexualis and improved general and psyche-emotional
 condition of the infertile couple particulary taking into account the fact that we recommend the use of Tribulus also to the husbands. No side
 effects were observed in the intermittent application of Tribulus.

Age distribution of female patients treated with protodioscin
Figure 1

Age distribution of female patients treated with protodioscin
Figure 2

Distribution of female patients treated with protodioscin by preceding
hormonal, surgical, or combined therapy
Figure 3


              Comparative data on the effect of Tribulus, Stimovul, Clostybegit, Fertodur on females with endogenous infertility

    Table 1
 

 Group B
 The age distribution of the patients in this group is represented on Table 1. Only four of them are younger than 40 years and 2 over 60
 years of age. Eighty percent of all treated women are in the age group 40 to 55.

 Twenty six patients were with the natural onset of menopause and the remaining 24 (48%) – postoperative castration climacteric (Table 2).
 The duration of the menopausal syndrome is shown on Table 3. As seen in a considerable part of patients the menopause dated back on
 the year prior to therapy with Tribulus. Those were mainly women with postoperative menopause.

                                                                            Distribution of patients by age
                                                                                          Table 1

                                         Effect of Tribulus during menopause distribution of patients by type of menopause
                                                                                            Table 2

                                                                  Distribution of patients by duration of menopause
                                                                                            Table 3

 The clinical picture of the menopausal syndrome in the group under study was predominated by several major symptoms represented
 diagrammatically on Tables 4 and 5.

Effect of protodioscin during menopause distribution of patients by incidence of some symptoms before treatement
Table4

                                                                   Distribution of patients by type of libido sexualis
                                                                                               Table 5

 Nervous vegetative manifestations were quite frequent with all treated women. The hot flash was present in 100% of women, sweating in
 78%, insomnia in 82%, and unmotivated superexcitation in 44%.

 From the cardiovascular changes, the heaviness in the heart region was predominant (60%) and changes in the blood pressure and ECG
 were observed in 16 women (22%). Libido sexualis was unchanged in only two women (in comparison with the previous state) greatly
 decreased to completely lost desire for sexual contacts were characteristic to 56% of all patients.

 It should be noted that the intake of placebo tablets by 46 from 50 women did not result in a favorable effect on any complaint
 (Table 6)

                                                  Distribution of patients by duration of placebo treatment
                                                                                   Table 6

 According to the selected signs for classification we established, complete or almost complete disappearance of all or most of the
 symptoms were found in 49 from 50 treated patients (98%). Only in one woman did Tribulus not have an effect on the menopausal
 syndrome and she was transferred to other treatments. Table 7 shows that in 50% of the treated women the course of treatment needed
 not less than 110 up to 180 tablets to achieve favorable effect. In 10% of the women this dose was even higher – 190 to 220 tablets. The
 average effective doses are given in Table 8 and in the greater number of women those were more than 100 tablets per course of treatment.
 The effect obtained was retained by a maintenance dose of 2 to 3 tablets a day in 84% of the treated women (Table 9).

Distribution of patients by the total effective dose of protodioscin
Table 7

Total effective dose of protodioscin
Table 8

                                                    Distribution of patients by the supporting dose of protodioscin
                                                                                         Table9

 The dynamic cytological monitoring of the progesterone – estrogen level (vaginal cytopreparation) showed that only in 14% of the patients
 there was present a high initial level of estrogen, while in 44% of them it was low or very low (Table 10).

Distribution of patients by level of progesterone/estrogen according to hormonal cytological examination
Table 10

 The particularly strict radioimmunological monitoring is shown on Table 11 and Table 12.

Effect of protodioscin during menopause radioimmunoassays
Table 11

 The variance analysis showed that both the mean values and the confidence interval are within the limits normal to the age. Comparison of
 these data prior to and after therapy showed that gonadotropic hormones levels decreased compared to the initial values, while the ovarian
 hormones did not demonstrate such a decrease. There was even an insignificant increase especially in the E2 hormone. These data together
 with the clinical picture can account for the favorable influence on the menopausal complaints and the considerably enhanced libido sexualis
 in two-third of the treated women.

 In this case the effect of Tribulus is equivalent, and in some cases even better than, that of the estrogen-testosterone hormonal preparation
 Ambosex without the adverse side effect of the latter such as virilization and tendency for weight gain.

 Side effect in treatment with Tribulus
 Nausea, vomiting, allergy phenomena, and intolerance were not observed. The preparation is well tolerated. It is worthwhile to note the
 fact that after achieving the desireable effect the abrupt decrease in the effective dose down to the maintenance dosage results in the sudden
 and complete unlocking of almost the whole menopausal symptom complex. Therefore, the transition from the effective dose to the
 maintenance dose should be gradual and for a longer period of time.

 Conclusion
 Our long-term experience with the use of the preparation Tribulus for treatment of infertility mainly in women, but quite frequently in men as
 well, make us recommend it for disturbed gamete formation due to stress situations, long years of infertile marital life, impaired or almost
 missing libido sexualis, leading to anovulatory menstruation cycles, dyskinetic changes of fallopian tubes and qualitative changes in the
 sperm.

 A combination of Tribulus with suitable hormone preparations results in potentiating its positive effect which explains its use in everyday
 practice for treatment of infertility in the family.

 The opinion of the research team, based on the experience from treatment of more than 150 women with natural or postoperative
 menopause, is that Tribulus can successfully be used for treatment of the menopausal syndrome in women.

 Tribulus
 Composition: a natural product, obtained from the overground part of the plant Tribulus terrestris, containing mainly saponins of the
 furostanol type with a predominant quantity of protodioscin (no less than 45%).

 Action: non-hormonal preparation which restores and improves libido sexualis in men, improves and prolongs the duration of erection. It
 exerts a stimulating influence on spermatogenesis by increasing the number of spermatozoa and their mobility. It increases the level of
 testosterone.

 It improves libido sexualis in women, exerts a slight stimulating ovulation effect, it has a favorable influence on vasomotory manifestation
 during natural and post-castration climacterium, as well as on subjective complains such as insomnia, general tenseness, irritability or
 apathy, etc.

 Indication: in men – impotentia coeundi in Klinefelter’s syndrome, varicocele, Cryptorchism, hypotrophy of testicles, syndrome of
 Noonan, sterility on the basis of idiopathic oligoasthenozoospermia idiopathic azoospermia, varicocele.

 In women – endocrinous ovarian sterility, climacteric and post-castration syndrome with expressed vasomotory and neurasthenic
 manifestations.

 Contraindication – none

 Application: in men – the dosage and duration of treatment are determined according to the character and gravity of disease. Most often,
 the dose is 1 to 2 tablets 3 times a day during meals. The treatment duration is as follows: in case of impotential coeundi: 40 to 50 days at
 least in sterility 70 to 90 days.

 In women, the treatment is strictly individual and depends on the gravity of manifestations. The dose most often used here is also 1-2 tablets
 3 times a day during meals. In cases of sterility the preparation is applied from the first to the twelveth days of the menstruation cycle. In
 postcastration and climacteric syndrome the treatment lasts 60 to 90 days. After an improvement is obtained the dose is reduced to 2
 tablets daily for another 50 to 60 days as supporting dose.
 

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