Stefano Lello

Istituto Dermopatico dell'Immacolata, Roma, Latium, Italy

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Publications (42)91.12 Total impact

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    ABSTRACT: Abstract There is great interest in new treatments of osteoporosis owing to general ageing of population and increased risk for fragility fractures in the elderly. Current therapies show a good efficacy in improving bone quality and bone density, but, in spite of a certain reduction in fracture rate, according to each treatment, the problem of osteoporotic fractures is yet far from to be solved. Moreover, some treatments may produce different side effects. Denosumab (Dmab), a receptor activator of nuclear factor kappa-B ligand (RANKL)-inhibitor, is an agent recently introduced in clinical practice for treatment of osteoporosis of postmenopausal women. Dmab has improved bone mineral density and prevented new vertebral and non-vertebral fractures with a similar efficacy in comparison with alendronate. Many clinical studies showed Dmab produces also significant improvement versus placebo in bone quality as indicated by decreasing markers of bone turnover. Patients using Dmab reported less risk of AFF (Atypical Femoral Fractures) and ONJ (Osteonecrosis of the Jaw) with an increased number of cellulitis. Here, we review articles using Dmab for female post-menopausal osteoporosis.
    Gynecological Endocrinology 03/2014; · 1.30 Impact Factor
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    ABSTRACT: Abstract The Pill has undergone many changes since its first appearance some 50 years ago. Key developments included the reduction of ethinylestradiol doses and the synthesis of new progestins in order to increase safety, compliance and efficiency. Low-dose combined oral contraceptives (COCs) are currently the preferred option for millions of women. Due to this widespread use, it has been argued that the safety of COCs should be even better, raising the threshold for excellence. Yet in spite of major improvements, there is still an associated risk of venous thromboembolism (VTE). The next step in COCs' evolution should take total estrogenicity and hepatic estro-androgenic balance into account. The focus on the estrogen component - which has not changed in 50 years - has yielded a new class of natural estrogen pills. Following the introduction of a first quadriphasic pill, a monophasic estradiol pill based on the concept of "natural balance" was subsequently made available. These recent achievements could represent a step forward in the evolution of COCs and pave the way for better safety.
    Gynecological Endocrinology 08/2013; · 1.30 Impact Factor
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    ABSTRACT: Abstract We investigated whether a formulation containing vitamins and minerals (vit&min) could improve the worsening of mood changes occurring after delivery ("a.d."). The study was performed in 552 healthy non-anaemic puerperal women ("p.w") without risk factors for puerperal depression ("p.d"). They were at their first full-term pregnancy, and spontaneously delivered healthy newborns. The Edinburgh Depression Postnatal scale (EPDS) evaluates the psychological status of "p.w". EPDS was administered the 3rd (visit 1), 15th (visit 2) and 30th (visit 3) day "a.d.". An EPDS >12 indicates a major susceptibility to "p.d". At the same time intervals, haemoglobin, iron and ferritin (haematological parameters) levels were evaluated. After visit 1, the subjects were randomized to vit&min treatment (group A; N.274) or to calcium/vitamin D3 treatment (group B; N.278). In both groups haematological parameters significantly increased without differences between the groups. EPDS score improved in both groups, but in the group A, the EPDS decrease was significantly larger (p < 0.05) in comparison to the group B. This effect is mainly evident in subjects with a basal EPDS ≥12. An early examination of psychological condition could select "p.w." with a high susceptibility to neuronal changes occurring postpartum. Vit&min favourably modulates brain functions antagonizing the evolution to "p.d".
    Gynecological Endocrinology 06/2013; · 1.30 Impact Factor
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    ABSTRACT: Introduction: Bazedoxifene is a third-generation Selective Estrogen Receptor Modulator, developed on raloxifene's model, and investigated as treatment for postmenopausal osteoporosis and menopause management. Clinical trial have shown that bazedoxifene is effective as raloxifene in preventing bone loss in women at risk of osteoporosis and that in patients with osteoporosis it is effective in reducing the incidence of new vertebral fracture with a protection maintained for up 7 years. Areas covered: This drug evaluation presents the antifracture efficacy of bazedoxifine and evidence that it, unlike raloxifene, can reduce the rate of non-vertebral fractures in high-risk patients. The authors also review the effects of bazedoxifine has on reproduction tissues as well as the on lipid pattern. Additionally, the authors present the safety profile of bazedoxifine and discuss its prospects, specifically in relation to conjugated estrogen. Expert opinion: Despite its peculiar profile, bazedoxifene could be considered as a second-line therapy for women < 65 - 70 years of age, where bisphopshonates are contraindicated or not well tolerated. Furthermore, the authors believe that bazedoxifene could also have its place as a first-line therapy for younger postmenopausal patients in the management of menopause and prevention of osteoporosis; this could be prescribed either by itself or in combination with conjugated estrogen. The authors also highlight the fact that the association of bazedoxifene and conjugated estrogen could also be beneficial in the treatment of climacteric syndrome in patients with menopausal symptoms.
    Expert Opinion on Drug Metabolism &amp Toxicology 04/2013; · 2.94 Impact Factor
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    ABSTRACT: Decreasing levels of estrogens during menopause are associated with reduced bone density and an increased risk of osteoporosis. Many women also experience bothersome vasomotor and vaginal symptoms during the menopausal transition. Results of systematic reviews and meta-analyses of randomized controlled trials have shown that both systemic estrogen therapy or hormone therapy (estrogen combined with a progestin) are useful to prevent bone loss, and they are the most effective treatment for such climacteric symptoms as hot flushes, sweating, vaginal dryness, and dyspareunia. Unfortunately, estrogen therapy and hormone therapy increase the risk of endometrial and breast cancer, respectively. The selective estrogen receptor modulators (SERMs) result in positive estrogenic effects on bone, with no negative effects on the endometrium and breast but do not provide relief from postmenopausal symptoms. The combination of a SERM with estrogen as a tissue selective estrogen complex (TSEC) is a new strategy for the prevention of bone loss and the treatment of climacteric symptoms. This combination is particularly interesting from a clinical point of view, taking into account that estrogen alone did not increase breast cancer risk by the Women's Health Initiative. TSEC is hypothesized to provide the benefits of estrogen-alone therapy, with an improved tolerability profile because the SERM component can make possible the elimination of progestin. The objective of this review was to critically evaluate the evidence from the reports published to date on the use of bazedoxifene (a third-generation SERM) in combination with conjugated estrogens in postmenopausal women. The conclusion is that effectively, the combination of bazedoxifene and conjugated estrogens may be a promising alternative to hormone therapy for the prevention of osteoporosis and the treatment of postmenopausal symptoms in non-hysterectomized postmenopausal women.
    Drug Design, Development and Therapy 01/2013; 7:601-10. · 3.49 Impact Factor
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    ABSTRACT: INTRODUCTION: Progesterone (P), and its receptors (PRs), play a key role in uterine leiomyoma growth. Selective progesterone receptor modulators exert mixed antagonist and agonist effects on the PRs. Mifepristone, a PR-antagonist, reduces leiomyoma volume and related symptoms. Ulipristal acetate (UPA) exerts a potent antiprogestin activity, with less antiglucocorticoid activity compared to mifepristone. This property provides potential advantages for long-term use. AREAS COVERED: This paper focuses on the effect of UPA on leiomyoma's growth and related symptoms in women. The authors also evaluate UPA's efficacy in reducing leiomyoma's size and menorrhagia in Phase II/III trials. EXPERT OPINION: In the authors' opinion, UPA (5 mg/day) over 3 months can be used to plan the surgery in women with symptomatic leiomyomas. The tolerability and the safety of treatment over a period longer than 3 months have to be evaluated. The results of the follow-up treatment suggest that further studies could successfully evaluate the efficacy and the tolerability of intermittent 3-month courses of treatment.
    Expert Opinion on Drug Metabolism &amp Toxicology 06/2012; 8(7):901-8. · 2.94 Impact Factor
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    ABSTRACT: The risk for fragility fracture represents a problem of enormous magnitude. It is estimated that only a small fraction of women with this risk take the benefit of preventive measures. The relationship between estrogen and bone mass is well known as they are the other factors related to the risk for fracture. There are precise diagnostic methods, including a tool to diagnose the risk for fracture. Yet there continues to be an under-diagnosis, with the unrecoverable delay in instituting preventive measures. Women under the age of 70 years, being much more numerous than those older, and having risk factors, are a group in which it is essential to avoid that first fragility fracture. Today it is usual not to differentiate between the treatment and the prevention of osteoporosis since the common aim is to prevent fragility fractures. Included in this are women with osteoporosis or with low bone mass and increased risk for fracture, for whom risk factors play a primary role. There is clearly controversy over the type of treatment and its duration, especially given the possible adverse effects of long-term use. This justifies the concept of sequential treatment, even more so in women under the age of 70, since they presumably will need treatment for many years. Bone metabolism is age-dependent. In postmenopausal women under 70 years of age, the increase in bone resorption is clearly predominant, related to a sharp drop in estrogens. Thus a logical treatment is the prevention of fragility fractures by hormone replacement therapy (HRT) and, in asymptomatic women, selective estradiol receptor modulators (SERMs). Afterwards, there is a period of greater resorption, albeit less intense but continuous, when one could utilise anti-resorptive treatments such as bisphosphonates or denosumab or a dual agent like strontium ranelate. Bone formation treatment, such as parathyroid hormone (PTH), in women under 70 years will be uncommon. That is because it should be used in cases where the formation is greatly diminished and there is a high risk for fracture, something found in much older women.
    Gynecological Endocrinology 05/2012; 28(10):770-86. · 1.30 Impact Factor
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    ABSTRACT: Background  Despite it is accepted that acne is mostly caused by an hyper-responsiveness of the pilo-sebaceous unit to normal circulating androgen hormones, in a few patients, especially women, acneic lesions can be associated with increased serum androgen levels (hyperandrogenism), of which polycystic ovary syndrome (PCOS) is the most common cause. In women with acne and proven PCOS therapy with estroprogestins (EPs) can be an excellent option. Objective  The aim of the study was to assess the effects of two estroprogestins (EPs), ethinyl-estradiol (EE) 30 mcg/drospirenone (DRSP) 3 mg, and ethinyl-estradiol (EE) 30 mcg/chlormadinone acetate (CMA) 2 mg, both on increased serum androgen levels and on several skin parameters in women affected by mild to severe acne and polycystic ovary syndrome (PCOS). Methods  Fifty-nine women were randomized to receive EE/DRSP (n = 32) or EE/CMA (n = 27) for six months. Evaluation of serum androgen levels, grading of acne and hirsutism (respectively with Pillsbury and Ferriman-Gallwey score) and non-invasive assessment of skin hydration, transepidermal water loss (TEWL) and skin homogeneity were performed at baseline, at 3 and 6 months (end of treatment). Results  Both treatments were well tolerated and showed a significant improvement of skin and hormonal parameters, although EE/DRSP showed a more potent effect on acne and seborrhea. Conclusions  Estroprogestins represent an effective and safe treatment in women with acne and polycystic ovary syndrome (PCOS). Nevertheless, the combination EE 30 mcg/DRSP 3 mg appears to be a more potent therapeutic option.
    Journal of the European Academy of Dermatology and Venereology 10/2011; 26(11):1364-71. · 2.69 Impact Factor
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    ABSTRACT: A Multidisciplinary National Panel of Experts in the management of Menopause and Postmenopausal Osteoporosis was created to determine the specific positioning of Bazedoxifene acetate (BZA), a third-generation selective estrogen receptor modulator (SERM), in the field of available therapeutic options in prevention and treatment of postmenopausal osteoporosis.There are various therapeutic options in prevention and treatment for postmenopausal osteoporosis, but nevertheless the problem of osteoporosis and osteoporosis-related fractures is not yet resolved today.In view of this unmet medical need, to have new treatments with efficacy and safety profile so good to therapeutically manage even larger groups of population is the conceptual basis to reduce the devastating impact of this disease on individual's morbidity and mortality, and on public health expense.The Panel has, moreover, pointed up the need to increase the awareness about the issue "osteopenia" as a risk factor for fracture to consider in daily clinical practice and the opportunity to evaluate fracture risk using an adequate algorithm (for example, FRAX®, deFRA®), which integrates the result obtained by densitometry (Bone Mineral Density, BMD) (1, 2) and clinical risk factors, in order to consider threshold values for pharmacological intervention.As for prevention and treatment and different groups of age in women's life, it is evident as in the group ranging in age 50 to 65 years the reference Specialist may be the Gynecologist, as the Woman's doctor, even if other Specialists could be interested (Endocrinologist, Rheumatologist, Internist, General Practitioner, or other Specialist who is seeing a patient with osteopenia/osteoporosis). The involved Specialist, necessarily, has to make preventative and/or therapeutic strategies for osteopenia/osteoporosis.After the publication of the study Women's Health Initiative (WHI) in 2002 (3), there was a decrease in applying Hormonal Replacement Therapy (HRT) or Hormone Therapy (HT), that even if is prescribed for climacteric symptoms (hot flushes, night sweats, etc.) can prevent bone loss and reduce osteoporosis-related fracture risk. The lower use of HRT (HT) has increased and still increases the risk of developing, in postmenopausal women, osteopenia and osteoporosis, with increased fracture risk, as it is demonstrated by N.O.R.A. Study (National Osteoporosis Risk Assessment) published in 2004 (4).On the other hand, the different treatments available for osteoporosis therapy, significantly decrease the relative risk of osteoporosis, but the percentage of non-treated or under-treated patients remains high. Thus, it is still fundamental to have at disposal further treatments with proven efficacy in preventing and treating osteopenia and osteoporosis in everyday clinical practice.
    Clinical cases in mineral and bone metabolism : the official journal of the Italian Society of Osteoporosis, Mineral Metabolism, and Skeletal Diseases. 09/2011; 8(3):29-32.
  • S Lello
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    ABSTRACT: Prevention of osteopenia/osteoporosis in postmenopausal patients can reduce fracture risk. In this view, the use of Selective Estrogen Receptor Modulators (SERMs) appear to be important in managing this condition. Bazedoxifene Acetate (BZA) is a third-generation SERM that showed to protect bone mass in postmenopausal women with osteopenia, and to reduce vertebral fracture risk in osteoporotic postmenopausal women; moreover, BZA decreased the non-vertebral fracture risk in a subgroup of patients at high-risk for fracture in comparison to placebo. BZA showed no stimulating effects on endometrium and breast. BZA can be a valid option in management of osteopenia/osteoporosis in postmenopause.
    Minerva ginecologica 06/2011; 63(3):305-14.
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    ABSTRACT: The effects of tibolone on cardiovascular risk is not yet fully understood today. We designed this study to assess the effect of the menopausal status and tibolone treatment (2.5 mg/day for 3 months) on different biomarkers of cardiovascular risk in healthy women. Blood arterial pressure were measured, and blood samples collected for glucose, lipid profile (total cholesterol, high density lipoproteins, HDL, low density lipoproteins, and triglycerides), inflammatory (C-reactive protein, Interleukin-6, IL-6, tumor necrosis factor alpha, TNF alpha) and oxidative stress (hydroperoxides and antioxidant capacity) evaluation in 15 premenopausal (mean age: 30 +/- 4 years) and 15 postmenopausal (mean age: 52 +/- 3, mean time from menopause 1.4 +/- 0.4 years) women before and after tibolone treatment. The menopausal status is associated with increased systolic and diastolic pressure (p<0.05), higher IL-6 (p<0.05) and TNF alpha (p<0.01), and lower antioxidants (p<0.01). However, blood pressure (p<0.05), glucose (p<0.05), TNF alpha (p<0.05) and HDL (p<0.05) fell after tibolone, which did not significantly affect levels of the other biochemical parameters. As menopause is associated with increased blood pressure, inflammation and oxidative stress, tibolone restores blood pressure and has beneficial effect on inflammation and glycemia without worsening oxidative stress, although it also reduces HDL levels. Such modifications should be taken into account when tailoring menopausal therapies to specific requirements of each woman.
    Gynecological Endocrinology 03/2011; 27(3):163-9. · 1.30 Impact Factor
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    ABSTRACT: evaluate the efficacy of an estroprogestin EP containing 20 mcg ethinilestradiol (EE) and 3 mg drospirenone (DRSP) in the treatment of hyperandrogenism. In this study, twenty hyperandrogenic patients were treated with an EP containing EE 20 mcg and DRSP 3 mg in 24+4 regimen for three months. Skin evaluation was performed both quantitatively and qualitatively. This EP combination showed, after a short-term treatment (three months) to decrease significantly seborrhea, acne, and circulating androgens (testosterone, deidroepiandrosterone sulphate, and androstenedione), while increased sex hormone binding globulin levels. Moreover, this EE 20 mcg/DRSP 3mg EP combination changed some parameters of skin quality, increasing corneometry (a parameter related to skin hydration), and reduced trans epidermal water loss (TEWL, a parameter related to skin evaporation), and erythema (a parameter related to skin inflammation). These results could be taken into account in individualizing the treatment of hyperandrogenic patients.
    Minerva ginecologica 12/2010; 62(6):509-13.
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    ABSTRACT: To critically discuss the use of tibolone (T), in light of a series of very recent double-blind placebo (PL) controlled trials (LISA, LIFT, OPAL, THEBES, LIBERATE) conducted worldwide in a large number of postmenopausal women (PMW). The most relevant publications on T therapy in PMW were considered with emphasis on menopausal symptoms, quality of life, sexuality, bone, cardiovascular system (CVS) and oncologic risk. T significantly relieves climacteric symptoms and improves mood and sexual well-being (LISA). T is as effective as estrogen-progestin therapy in preventing bone loss and reducing the relative risk of vertebral and non-vertebral fractures (LIFT). By using surrogate endpoints of the individual risks for the CVS, studies show mixed results, but a favourable effect on acute miocardial infarction and thromboembolism has been documented (THEBES, LIFT, OPAL). Although findings about endometrial and colon cancer are reassuring, conclusive data on breast cancer risk with T are not available and an increased risk of recurrence in women with previous breast cancer emerged (LIBERATE). T is effective in treating menopausal syndrome with a good tolerability profile. In spite of some unsolved issues in term of safety, T is still a good treatment option for early PMW.
    Gynecological Endocrinology 11/2010; 26(11):804-14. · 1.30 Impact Factor
  • S Lello, L Colonna
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    ABSTRACT: Progestins are a group of different compounds sharing the ability to induce secretory changes on a endometrium pretreated with estrogen, while they are different in some abilities, for example the interaction with receptors other than progestin receptor, as androgenic or mineralocorticoid receptor. Some progestins have antiandrogenic properties and are used in treating hyperandrogenic manifestations (seborrhea, acne, hirsutism). The different clinical pharmacology of the various progestins is the basis for an individualized treatment in different clinical conditions. Key words.
    Minerva ginecologica 10/2010; 62(5):483-95.
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    ABSTRACT: Chlormadinone acetate (CMA) is a progestin compound similar to progesterone, with antiandrogenic properties. In healthy eumenorrheic women, it was demonstrated that the monophasic estroprogestin formulation containing CMA (2 mg) plus ethinyl estradiol (EE) (30 mcg) (EE30+CMA) is efficacious both in reducing hyperandrogenic symptoms, fat mass and in improving lipoprotein panel, without changes in insulin-glucose metabolism. These metabolic properties are important for women affected by polycystic ovary syndrome (PCOS) in whom there is a predisposition to insulin resistance. We studied whether in young nonobese women with PCOS (15 subjects, EE30+CMA-PCOS group) a six-cycle treatment with EE30+CMA can reduce androgen levels, androgen bioavailability and the score of hirsutism and acne, and modify glucose-insulin metabolism evaluated by the oral glucose tolerance test and the body composition evaluated by bio-impedenziometry. These parameters were evaluated before (first visit) and during the sixth cycle of EE30+CMA (second visit). All the results were compared with those of a matched-age-group of nonobese PCOS women (15 subjects, no OC-PCOS group) evaluated before (first visit) and after six menstrual cycles in which they did not use any drug or oral contraceptive (second visit). In the EE30+CMA-PCOS group women, androgen levels and bioavailability, hirsutism and acne score were significantly lower at the second than at the first visit, whereas they did not change in no OC-PCOS group. At the second visit, in both groups, glucose-insulin metabolism and body composition parameters were not affected. A six-cycle treatment with EE30+CMA is efficacious in nonobese PCOS women to improve hyperandrogenic symptoms, without negative interferences both on body composition and on insulin-glucose metabolism.
    Contraception 08/2010; 82(2):131-8. · 3.09 Impact Factor
  • Stefano Lello
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    ABSTRACT: This review summarizes the pharmacology, safety and clinical efficacy of nomegestrol acetate, based on the available published literature, and assesses the pharmacological characteristics that underlie a role in different gynaecological disorders and hormone replacement therapy (HRT), and a potential role in combination estrogen/progestogen oral contraception. Nomegestrol acetate is a potent, orally active progestogen with a favourable tolerability profile and neutral metabolic characteristics. Unlike the majority of older progestogens, which were 19-nortestosterone derivatives synthesized primarily for their antigonadotropic activity as a component of hormonal contraception in combination with an estrogen, nomegestrol acetate is a 19-norprogesterone derivative designed to bind specifically to the progesterone receptor, and is relatively lacking in affinity for other steroid receptors. Nomegestrol acetate exerts strong antiestrogenic effects at the level of the endometrium and has potent antigonadotropic activity, but without any residual androgenic or glucocorticoid properties. At a dosage of 1.25 mg/day, nomegestrol acetate inhibits ovulation while permitting follicle growth, whereas at dosages of 2.5 or 5 mg/day, both ovulation and follicle development are suppressed. The antigonadotropic action of nomegestrol acetate is mediated, like other progestins, at the hypothalamic and pituitary level. Moreover, nomegestrol acetate has partial antiandrogenic activity. Absorption of nomegestrol acetate is rapid after oral administration, reaching a peak serum concentration within 4 hours, with a terminal half-life of approximately 50 hours. Nomegestrol acetate has been used successfully for the treatment of some gynaecological disorders (menstrual disturbances, dysmenorrhoea, premenstrual syndrome) and as a component of HRT in combination with estradiol for the relief of menopausal symptoms; it has been approved in Europe as monotherapy for the treatment of the menopausal syndrome, uterine diseases and menorrhagia, and in combination with an estrogen for the treatment of menopausal symptoms. In vitro data suggest that nomegestrol acetate preserves the beneficial haemostatic effects of estrogen; furthermore, nomegestrol acetate has a neutral or beneficial effect on lipid profiles, and does not adversely affect glucose metabolism or bodyweight. Nomegestrol acetate has shown a lack of profilerative activity in normal and cancerous breast tissue, and does not have a deleterious effect on bone remodelling. These potent antigonadotropic properties, and other beneficial metabolic and pharmacological characteristics, suggest that nomegestrol acetate can be an effective progestogen for use in combination with an estrogen in oral estrogen/progestogen contraceptive treatment and in HRT, while it also provides some non-contraceptive benefits for women's health.
    Drugs 03/2010; 70(5):541-59. · 4.13 Impact Factor
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    ABSTRACT: To assess perception of sexuality and awareness of the impact of testosterone on sexual desire in a clinical sample of Italian women with surgical menopause. In the present cross-sectional study, a structured interview on sexuality-related menopausal symptoms, attitudes towards sexuality and menopausal profile was administered to 568 women (age range 35-69 years) with bilateral oophorectomy with and without hysterectomy for benign conditions. The majority of women (58% yes; 36% most of the time) reported they were satisfied with their sexual life before surgical menopause. After oophorectomy, 79.3% noted the appearance/worsening of vaginal dryness, whereas the reduction of sexual desire was reported by 78.7%. Women with low sexual desire (n = 436) were significantly distressed (59.7%) and reported an impairment (24.8% yes/yes, very much) in the relationship with their partner. Sexual reactions of the partner reported by women included reduced sexual desire (17.8%), sexual dysfunction (5.1%) and fears of giving pain/lack of pleasure (28.3%). A high number of women (88.2%) would be willing to discuss sexual matters with their doctors and would consider therapeutic options. Only 36.8% were aware that a lack of testosterone might impact on sexual desire but 71% would like to know more about the role of testosterone. Hormone replacement therapy was used by 38.4% of the women. These data suggest that women experience significant vaginal dryness and low sexual desire and report a significant distress in the relationship with their partner after surgical menopause. Sexual counseling is mandatory in order to discuss potential therapeutic strategies, including testosterone use.
    Climacteric 12/2009; 12(6):533-40. · 1.96 Impact Factor
  • S Lello
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    ABSTRACT: Progestogens are used in clinical practice in some conditions. Their effects depend on their chemical structure, pharmacokinetics, pharmacodynamics, with important differences among various progestogens. Generally, progestins are classified according to their parent molecule, of which often they keep some features. Derivatives of 19-nor-progesterone are characterized by high selectivity of action on progestin receptor. In particular, nomegestrol acetate (NomAc) shows an important progestational potency, neutral gluco-lipid profile, and antigonadotropic activity. It is used for treating menstrual cycle disorders and for hormone replacement therapy in menopause in association with an estrogen. In future, thanks to its antigonadotropic activity, NomAc will be used in estroprogestin combinations in fertile women, thus taking advantage of its tolerability profile and obtaining numerous non-contraceptive benefits as well.
    Minerva ginecologica 10/2009; 61(5):459-63.
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    ABSTRACT: We aimed to evaluate whether a six-cycle treatment with oral contraceptive containing 30 mcg of ethinylestradiol (EE2) plus 2 mg of chlormadinone acetate (CMA) (EE2+CMA) alters body weight (BW) and body composition of healthy young women with normal menstrual cycles. The results in treated subjects were compared to those obtained in nontreated women as control. Multifrequency bioelectrical impedance analysis (MF-BIA) was performed in 48 healthy young women during the follicular phase of their menstrual cycle. Of this group, 24 women were treated with EE2+CMA, and the MF-BIA was repeated at the third and sixth cycle of treatment. The remaining 24 women were submitted to the same examinations after three and six cycles without any treatment. Total body water (TBW), intracellular water (ICW), extracellular water (ECW), fat mass (FM) and fat-free mass (FFM) were calculated. Waist-to-hip ratio (WHR), BW, blood pressure, and the plasma concentrations of electrolytes were also measured at each visit. Mean FM significantly (p<.05) decreased in the EE2+CMA group from basal levels of 14.23+/-1.03 to 13.51+/-1.09 and 12.71+/-1.02 kg at the third and sixth cycle of treatment, respectively. Stable values were seen in the control group. During observation, other parameters (BW, WHR, TBW, ECW, ICW, FFM) remained unchanged in all subjects. EE2+CMA reduces FM without altering TBW, ICW, ECW. These preliminary results suggest that progestational activity of CMA could balance both fluid retention and weight gain elicited by EE2.
    Contraception 03/2009; 79(2):117-21. · 3.09 Impact Factor
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    ABSTRACT: Hyperandrogenic manifestation in women, such as seborrhea, acne and increased hair growth are common reasons of psychological distress. Skin appearance is very important for young women. This study evaluated the hormonal and skin effects of two estroprogestins (EPs) containing ethinyl-estradiol (EE) 30 microg associated with drospirenone (DRSP) 3 mg or chlormadinone acetate (CMA) 2 mg, respectively. Fifty-five women with signs and symptoms of hyperandrogenism (seborrhea, acne and increased hair growth) were enrolled in the study; randomly, 30 women were treated with EE 30 microg + DRSP 3 mg and 25 with EE 30 microg + CMA 2 mg. Follicle-stimulating hormone (FSH), luteinising hormone (LH), 17-hydroxyprogesterone (17OHP), androstenedione (A), testosterone (T), dehydroepiandrosterone sulfate (DHEAS), sex hormone binding globulin (SHBG) and free androgen index (T x 100/SHBG, FAI) were assessed at baseline, and after 3 and 6 months of treatment with EPs. Effects on seborrhea, acne and increased hair growth (as Ferriman-Gallwey score) were also evaluated at the same time points. Finally, skin hydration, transepidermal water loss (TEWL) and skin homogeneity were studied with non-invasive technique during the study. Treatment for 6 months with both EPs decreased significantly the circulating androgen levels (A, T, DHEAS) and FAI, and increased SHBG levels; also skin pattern was improved. EP containing EE and DRSP was better than EP containing EE and CMA as for skin changes, as seborrhea, acne, increased hair, hydration, homogeneity and overall quality of the skin; moreover, hormonal changes (as FAI) under therapy were more pronounced with EE/DRSP than EE/CMA. These effects may be considered in EP choice and could be important in improving patient's compliance and quality of life in hyperandrogenic women.
    Gynecological Endocrinology 01/2009; 24(12):718-23. · 1.30 Impact Factor

Publication Stats

242 Citations
91.12 Total Impact Points

Institutions

  • 2009–2014
    • Istituto Dermopatico dell'Immacolata
      Roma, Latium, Italy
  • 2013
    • University of Verona
      • Department of Medicine
      Verona, Veneto, Italy
  • 2003–2013
    • Università degli studi di Cagliari
      • Department of Surgical Science
      Cagliari, Sardinia, Italy
  • 2004
    • Istituto di Ricovero e Cura a Carattere Scientifico San Raffaele Pisana
      Roma, Latium, Italy
  • 1998–2001
    • University of Rome Tor Vergata
      • Dipartimento di Biologia
      Roma, Latium, Italy