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Biomedical subjects

Giovanni A Tommaselli

Publications and source records attributed to Giovanni A Tommaselli.

10 recordsLinked to original sources

Bleeding patterns during continuous estradiol with different sequential progestogens therapy.

OBJECTIVE: : To evaluate the effects on monthly bleeding of four different progestogens administered in association with transdermal estradiol in a continuous sequential estrogen-progestin therapy (CS-EPT). DESIGN: : This prospective, open, randomized, clinical trial included 100 healthy postmenopausal women. Patients were randomized into four treatment groups, each consisting of 25 women. Treatment consisted of 50 mug/day transdermal 17beta-estradiol for all women combined to receive four different progestogens (group A: medroxyprogesterone acetate, 10 mg/day; group B: nomegestrol acetate, 5 mg/day; group C: dydrogesterone, 10 mg/day; group D: micronized progesterone, 200 mg/day) per os from the 14th to 25th day of each 28-day cycle. The duration of treatment was 12 cycles. Patients were asked to record in a daily diary the occurrence of any vaginal bleeding, the days of application of each patch, the days of assumption of the different progestogens, and the exact moment of bleeding onset. RESULTS: : A total of 937 cycles could be evaluated. In 690 cycles (73.6%), regular progestogen-related bleeding was reported. Among the other cycles, we observed 73 episodes of amenorrhea (7.8%, each one lasting one cycle), 78 episodes of irregular bleeding (8.3%), and 96 episodes of spotting (10.2%). Patients receiving nomegestrol acetate had a significantly higher incidence of regular progestogen-associated bleeding in comparison with those receiving medroxyprogesterone acetate or natural progesterone, and patients receiving dydrogesterone had a significantly higher incidence of regular progestogen-associated bleeding in comparison with those receiving natural progesterone. CONCLUSION: : Our data suggest that CS-EPT generally leads to regular withdrawal bleeding in women without uterine pathology. Micronized progesterone seems to induce more irregular bleeding episodes.

Administration, Cutaneous↗

Evaluation of skeletal status by quantitative ultrasonometry in postmenopausal women without known risk factors for osteoporosis.

The objective of our study was to evaluate bone density in Italian postmenopausal women without clinical risk factors for osteoporosis resident in the Naples area using quantitative ultrasonometry of bone (QUS). Subjects were 1149 Italian postmenopausal women (age: 54.9 +/- 5.0 years (mean +/- standard deviation); range: 45-74 years) resident in the Naples area. Clinical risk factors for osteoporosis resulting in exclusion from the study were family history of osteoporosis, dietary, smoking and alcohol habits, personal history of fractures and/or metabolic diseases. The following QUS parameters were calculated: amplitude-dependent speed of sound (AD-SoS), T-score and Z-score. We found significant inverse correlations between AD-SoS and age (r = - 0.23), time since menopause (r = - 0.25) and body mass index (BMI) (r = - 0.16). The same was observed for T-score. In contrast, Z-score showed a significant positive correlation with age and time since menopause, and a negative correlation with BMI. A T-score suggestive of high risk for osteoporosis (less than -3.2) was found in 1.6% of subjects, while a T-score suggestive of moderate risk for osteoporosis (between -3.2 and -2) was found in 19.3% of patients. In this group of women without clinical risk factors for osteoporosis we found a very low prevalence of QUS results suggesting a high risk for osteoporosis. However, a condition of 'moderate' risk for osteoporosis was present in a remarkable percentage of these women.

Absorptiometry, Photon↗

Effects of an oral contraceptive containing drospirenone on bone turnover and bone mineral density.

OBJECTIVE: To compare the effects of a new 21-day combined oral contraceptive containing 30 microg ethinyl/estradiol plus 3 mg drospirenone with a 21-day preparation containing 30 microg ethinyl/estradiol plus 75 microg gestodene on bone turnover and bone mineral density in young fertile women. METHODS: A randomized, controlled trial was conducted with healthy fertile women treated with 30 microg ethinyl/estradiol plus 3 mg drospirenone (group A; n = 24), 30 microg ethinyl/estradiol plus 75 microg gestodene (group B; n = 24) and healthy controls (group C, n = 23). At 3, 6, 9, and 12 months of the study, serum and urinary calcium, osteocalcin, urinary pyridinoline, and deoxypyridinoline were measured. At baseline and after 12 months, lumbar bone mineral density was determined by dual-energy X-ray absorptiometry. RESULTS: In groups A and B, urinary pyridinoline and deoxypyridinoline at 6, 9, and 12 months were significantly reduced in comparison with basal values and group C (P < .05). Pyridinoline and deoxypyridinoline levels were lower in group A than in group B throughout the study, but not significantly. In group A serum calcium levels were significantly increased after 6 months. At 12 months, no significant difference was detected in lumbar bone mineral density values among the 3 groups and in comparison with basal values. CONCLUSION: Both combined oral contraceptives exert a similar positive influence on bone turnover and bone-sparing effect in young postadolescent women.

Adult↗

Maternal serum and umbilical cord blood leptin concentrations with fetal growth restriction.

OBJECTIVE: To ascertain whether fetal growth restriction is associated with alterations of leptin concentrations in umbilical cord blood and maternal serum. METHODS: Maternal serum and umbilical cord blood leptin concentrations were determined by immunoradiometric assay at term in 43 women with uncomplicated singleton pregnancies (group A) and in 27 women with singleton pregnancies complicated by fetal growth restriction (group B), all with normal pregravid body mass index (BMI). RESULTS: Maternal serum leptin concentrations were significantly higher in group B compared with group A (45.0 ng/mL [range 34.2-54.9] versus 29.0 ng/mL [range 24.7-33.3]; P<.01). Umbilical cord blood leptin levels were significantly lower in group B compared with group A (8.4 ng/mL [range 3.6-13.2] versus 13.1 ng/mL [9.7-16.5]; P<.01). Maternal serum leptin levels were not significantly correlated with maternal BMI or with neonatal birth weight in either group. Umbilical cord blood leptin concentrations were significantly correlated with neonatal birth weight in both groups. CONCLUSION: Growth restricted fetuses at term show umbilical cord blood leptin concentrations significantly lower than those in normal fetuses, suggesting that fetal adipose tissue is a major source of leptin. Maternal serum leptin concentrations are higher in the presence of a growth restricted fetus. This increase might be due to an intrinsic placental mechanism, by which small placentas produce more leptin as a compensatory mechanism, or to early hypoxia.

Adult↗

Serum leptin levels in patients with premenstrual syndrome treated with GnRH analogues alone and in association with tibolone.

OBJECTIVE: Leptin seems to regulate reproductive function and it has been hypothesised that its secretion may be induced by oestrogens. Changes in its levels has been advocated as a determinant in the pathogenesis of premenstrual syndrome (PMS). We evaluated serum leptin levels in patients affected by PMS and in controls to establish: (i) if induced hypoestrogenism has an impact on leptin concentrations; (ii) if the administration of tibolone modifies the effects of hypoestrogenism on serum leptin levels; and (iii) if the improvement in PMS symptomatology can be correlated to changes in serum leptin levels. DESIGN: Prospective, randomized study. PATIENTS: Twenty-eight women affected by PMS and 20 unaffected controls. Affected patients were randomly assigned to two groups to receive leuprolide acetate (3.75 mg intramuscularly) plus tibolone (2.5 mg/day) (group A; n = 14) or plus placebo (group B; n = 14), at the onset of the vasomotor symptoms. MEASUREMENTS: Serum leptin, oestradiol and progesterone levels, PMS signs and symptoms evaluated during a 2 months' pretreament period and after 2 months of therapy. RESULTS: No differences in leptin levels among the three groups and within the same group at all time evaluated were observed. Oestradiol and progesterone concentrations were significantly lower in all groups during treatment in comparison with pretreatment values. Before therapy, leptin levels were positively correlated both with oestradiol and progesterone in the follicular and luteal phase in all groups. This correlation was lost after treatment. All PMS patients showed a significant improvement of the symptomatology. CONCLUSIONS: Hypoestrogenism induced by GnRH analogues (GnRHa) does not seem to influence leptin levels in normal women and those with PMS, and the addition of tibolone does not impact on these levels. Because PMS symptomatology did significantly improve during treatment with GnRHa alone, or in associtation with tibolone, it is unlikely that changes in leptin levels could have an important role in the pathophysiology of PMS.

Adult↗

Menstrual status and serum leptin levels in anorectic and in menstruating women with low body mass indexes.

OBJECTIVE: To evaluate serum leptin levels in anorectic women, menstruating women with low body mass indexes (BMI) and normally menstruating women with normal BMI. DESIGN: Prospective study. SETTING: University clinics. PATIENT(S): Fourteen amenorrheic patients with anorexia nervosa (group A), 11 menstruating women with a BMI <18 kg/m(2) (group B), and 20 normal controls. MAIN OUTCOME MEASURE(S): Determination of BMI, caloric intake, total fat mass, ovarian volume, and serum leptin, insulin-like growth factor I, FSH, LH, E(2), PRL, and TSH levels. INTERVENTION(S): None. RESULT(S): Mean BMI and fat mass were similar in groups A and B and significantly higher in controls. Mean caloric intake was significantly lower in group A than in group B and controls. Median serum leptin levels were significantly lower in group A than in group B and controls, and significantly lower in group B than in controls. Median serum insulin-like growth factor I levels were significantly lower in group A than in group B and controls. Binary segmentation analysis of groups A and B showed that LH was the most relevant variable in differentiating the two groups, followed by leptin. CONCLUSION(S): A threshold of leptin levels exist above which, even in the presence of low body mass indexes, the menstrual function is preserved.

Adult↗

Effects of bilateral ovariectomy and postoperative hormonal replacement therapy with 17beta-estradiol or raloxifene on serum leptin levels.

OBJECTIVE: To verify the effects of hypoestrogenism and replacement therapy on body mass index (BMI) and leptin in ovariectomized women. DESIGN: We conducted a longitudinal study on 56 women undergoing abdominal bilateral ovariectomy divided into three groups: 19 untreated controls, 18 scheduled to receive 17beta-estradiol, and 19 on raloxifene starting 15 days after surgery. Height, weight, and BMI were recorded on the day of surgery, 5 and 15 days later, and then after 6 months. Leptin and estradiol concentrations were determined by radioimmunoassay on the day of surgery, days 1, 5, and 15, and 6 months after. RESULTS: Leptin levels rose significantly on the day after surgery [median (range): 18.2 (9.8-25.0), 12.5 (9.1-20.9), and 20.5 (12.9-24.5); P< 0.01 v basal] and returned to values similar to baseline on day 5 in all groups. Six months later, controls showed significantly higher leptin levels in comparison with both treated women and basal values [median (range): 19.7 (10.4-22.8), 11.0 (7.6-16.9), and 13.5 (9.1-14.8) ng/ml; P< 0.01). Estradiol levels decreased in all groups, reaching statistical significance 5 days after surgery ( P< 0.01 v basal). A significant rise was observed 6 months after surgery in women treated with estrogens ( P< 0.01). Six months after surgery, BMI increased in untreated controls in comparison with treated women and baseline, although not significantly. CONCLUSIONS: The absence of modifications in leptin on days 5 and 15 after ovariectomy suggests that, in humans, estrogens may not exert an important effect on leptin secretion. After 6 months, replacement therapy maintained leptin levels and BMI was unmodified, whereas untreated controls showed a significant increase in leptin and a trend toward higher BMI, suggesting that replacement therapy may prevent changes in fat distribution and in leptin levels.

Administration, Cutaneous↗

Effects of hormone replacement therapy on ocular function in postmenopause.

OBJECTIVE: To evaluate the effect of hormone replacement therapy on climacteric ocular complaints, lacrimal secretion, intraocular pressure (IOP), and corneal thickness. DESIGN: A prospective, controlled, randomized study on 50 healthy women (mean age 53.4 +/- 3.8 years) at least 1 year after spontaneous menopause. Twenty-five women (group A) were treated with transdermal 17beta-estradiol (50 microg/day) and medroxyprogesterone acetate (10 mg/day) for 12 days per cycle. Twenty-five untreated women (group B) were used as a control group. All participants underwent eye examination at the beginning of the study and after 3 and 6 months of therapy to detect ocular diseases and to measure lachrymal secretion, IOP, and corneal thickness. RESULTS: No significant differences were observed between the two groups at the beginning of the study. After 3 and 6 months of treatment, we observed a significant reduction in the percentage of women in group A affected by ocular symptoms and in the severity of symptomatology in comparison with baseline and with group B (P < 0.01). A significant increase of both basal and stimulated lachrymal secretion was observed after 3 months of therapy in group A in comparison with baseline (P < 0.01). There was a significant decrease of IOP (P < 0.01) after 3 months of therapy in group A (P < 0.01), and a slight, nonsignificant increase of corneal thickness was observed in group A at 3 and 6 months in comparison with basal values. CONCLUSION: Our data suggest that hormone replacement therapy may exert a beneficial effect on ocular symptomatology, increase lachrymal secretion, reduce IOP, and increase corneal thickness.

Administration, Cutaneous↗

Serum leptin levels and body composition in postmenopausal women: effects of hormone therapy.

OBJECTIVE: To confirm the effect of postmenopausal hypoestrogenism and hormone therapy (HT) on body composition and serum leptin levels. DESIGN: Prospective, longitudinal study evaluating body composition (body mass index, and total and percent fat mass and lean mass measured at the arms, legs and trunk) with dual-energy x-ray absorptiometry and serum leptin levels by radioimmunoassay in 44 healthy postmenopausal women randomized to receive either no treatment (n = 22) or transdermal 17beta-estradiol (50 microg/day) in continuous regimen and nomegestrol (5 mg/day for 12 days/month) in a sequential regimen (n = 22). RESULTS: One year after the beginning of the study, in untreated women, total and trunk fat mass and percent fat were significantly increased, whereas trunk lean mass was significantly decreased. On the contrary, women treated with HT did not show any significant difference in body composition parameters. In untreated women, serum leptin levels were significantly increased at the end of the study in comparison with baseline values. Serum leptin levels at the other times evaluated were not significantly different from baseline values. In women treated with HT, serum leptin levels did not show significant changes throughout the study. CONCLUSIONS: Untreated postmenopausal women show an increase in total and percent fat mass and a centralization of fat distribution. Serum leptin levels parallel this increase, resulting in significantly higher levels 1 year after the study. Women treated with HT are protected against these changes. This may represent a protective mechanism against cardiovascular diseases.

Body Composition↗