[Show abstract][Hide abstract] ABSTRACT: The aetiology of bacterial vaginosis (BV) is still unclear but it is currently considered to be a synergistic polymicrobial syndrome. BV can often arise as a chronic or recurrent disease. The reason for such recurrences is not well elucidated. Previous studies have suggested that vaginal vitamin C may be a useful treatment in reducing recurrence rate, by increasing vaginal acidification and thereby making up for the decrease in hydrogen peroxide that results from a reduction in the number of lactobacilli present. Based on the above-mentioned consideration, a study was performed that aimed to evaluate the effect of vitamin C in the prophylaxis of BV relapses.
This was a randomised, double-blind, placebo-controlled, parallel-group clinical trial. One hundred and forty-two women, after having been cured from a recent episode of BV by either metronidazole or clindamycin, were randomised to receive vitamin C (74 patients) or placebo (68 patients) as prophylaxis for six monthly cycles, starting within 24 hours of the determination of 'BV cure'. The patients applied one vaginal tablet once a day for 6 consecutive days per month after menses.
The rate of BV recurrence during the first 3 months was considerably lower in the vitamin C group (6.8%) than in the placebo (14.7%) group. Considering a 6-month treatment period, the recurrence rate in the vitamin C group (16.2%) was significantly lower (P = 0.024) than in the placebo group (32.4%). Moreover, at the same time point, the survival analysis of Kaplan Meyer was significant in favour of the vitamin C group compared with the placebo group (P = 0.029).
The study showed that regular use of 250 mg ascorbic acid vaginal tablets on 6 days per month for 6 months after successful treatment of bacterial vaginosis halves the risk of recurrence from 32.4% to 16.2% (P = 0.024).
Journal of Clinical Medicine Research 08/2013; 5(4):309-15.
[Show abstract][Hide abstract] ABSTRACT: Primary headaches are common in women and impact on their quality of life and psychosocial functioning. Few data are available on sexuality in female headache sufferers.
An observational pilot study was conducted to assess sexual function and distress in women treated for primary headaches in a tertiary university center.
From a total of 194 women consecutively observed over a 3-month period, 100 patients were recruited. Migraine with and without aura, and tension-type headache, both episodic and chronic (CTTH), were diagnosed according to the International Classification of Headache Disorders. A detailed pharmacological history was collected, and anxiety and depression were assessed using validated scales. The Female Sexual Function Index (FSFI) and Female Sexual Distress Scale-Revised were administered.
The main outcome measures are sexual symptoms and distress in women treated for primary headaches.
More than 90% of the women had a median FSFI full-scale score under the validated cutoff, while 29% reported sexual distress. Hypoactive sexual desire disorder (HSDD) was diagnosed in 20% of the women and the pain domain score (median 2, score range 0-6) was highly affected by the head pain condition. However, the FSFI domain and full-scale scores did not significantly differ by headache diagnosis. The women with CTTH displayed a high rate of sexual distress (45.5%) and a strong negative correlation between desire, arousal, and full-scale FSFI score and number analgesics/month (r: -0.77, P=0.006; r: -0.76, P=0.006; and r: -0.68, P=0.02, respectively). Depression was positively correlated with sexual distress (r: 0.63, P=0.001) only in the women with CTTH.
Women treated for primary headaches were found to display a high rate of sexual symptoms and distress. Both migraine and tension-type headache were associated with sexual pain and HSDD, but women with CTTH seem to be more prone to develop sexual distress.
Journal of Sexual Medicine 03/2012; 9(3):761-9. · 3.51 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: As bacterial vaginosis (BV) is a potential cause of obstetric complications and gynecological disorders, there is substantial interest in establishing the most effective treatment. Standard treatment - metronidazole or clindamycin, by either vaginal or oral route � is followed by relapses in about 30% of cases, within a month from treatment completion. This inability to prevent recurrences reflects our lack of knowledge on the origins of BV. Atopobium vaginae has been recently reported to be associated with BV in around 80% of the cases and might be involved in the therapeutic failures. This review looks at the potential benefits of nifuratel against A. vaginae compared to the standard treatments with metronidazole and clindamycin. In vitro, nifuratel is able to inhibit the growth of A. vaginae, with a MIC range of 0.125-1 μg/mL; it is active against G. vaginalis and does not affect lactobacilli. Metronidazole is active against A. vaginae only at very high concentrations (8-256 μg/mL); it is partially active against G. vaginalis and also has no effect on lactobacilli. Clindamycin acts against A. vaginae with an MIC lower than 0.125 μg/mL and is active on G. vaginalis but it also affects lactobacilli, altering the vaginal environment. These observations suggest that nifuratel is probably the most valid therapeutic agent for BV treatment.
Current clinical pharmacology. 11/2011; 7(1):36-40.
[Show abstract][Hide abstract] ABSTRACT: Among primary headaches, migraine is the form more sensitive to the ovarian hormonal milieu. Migraine without aura (MO) benefits from the hyperestrogenic state of pregnancy and the lack of hormonal fluctuations, while migraine with aura (MA) presents distinctive features. Indeed, a very strong improvement of MO has been documented across gestation, and only a minority of pregnant women still suffers during the third trimester. On the other hand, fewer women with MA report improvement or remission, and new onset of aura may be observed during pregnancy. After delivery, breastfeeding exerts a protective action on migraine recurrence. The persistence of migraine during gestation seems to affect neonatal outcomes, and several studies indicate a link between migraine and an increased risk of developing gestational hypertension/preeclampsia and other vascular complications.
Current Pain and Headache Reports 04/2011; 15(4):289-94. · 1.67 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Migraine with aura (MA) is a contraindication to the use of combined oral contraceptives (COCs) because of the increased risk of ischemic stroke. Progestogen-only contraceptive pill (POP) is a safe alternative to COCs and it is preferable in women with cerebrovascular diseases or risk factors for stroke.
Prospective diary-based pilot study. Thirty women with MA (n = 15 who have never used COCs and n = 15 who had previously used COCs were diagnosed according to the International Headache Society criteria. The observational period lasted 9 months during which women filled in a diary with the clinical characteristics of headache attacks. After a 3-month run-in period, each subject received an estrogen-free desogestrel (DSG) (75 mcg/day)-containing OC (Cerazette(®); Schering-Plough, formerly NV Organon, Oss, The Netherlands). Follow-up evaluations were planned at the end of the third and sixth month of treatment.
The number (mean±S.D.) of migraine attacks was significantly reduced both in previous COCs users (from 3.9±1.0 to 2.9±0.8; p<.001) and nonusers (from 3.2±0.9 to 2.6±1.3; p<.02) following 6 months of POP use in comparison with the run-in period. Duration of headache pain did not differ significantly in both groups throughout the study. Interestingly enough, a beneficial POP effect on the duration (mean±S.D.) of visual aura (from 16.3±9.5 to 11.4±5.6 min) and on the total duration (mean±S.D.) of neurological symptoms (from 33.6±23.3 to 18.6±18.0 min) was only significantly reported by previous COCs users (p<.001, for both) by the end of the study period. The POP was well tolerated by each woman and the bleeding pattern was variable with a tendency towards infrequent bleeding.
The present study supports the use of the POP containing desogestrel in a population of women with MA and underlines a positive effect on symptoms of aura, especially in MA sensitive to previous use of COCs.
[Show abstract][Hide abstract] ABSTRACT: The present short review underlines the role of testosterone (T) in the motivational and satisfaction components of women's sexuality and critically discusses the strategies to treat hypoactive sexual desire disorder (HSDD), a condition of low desire associated with personal and/or interpersonal difficulties, which is more common in surgical menopausal women. There are multiple ways androgens target the brain regions (hypothalamic, limbic and cortical) involved in sexual function and behaviour. Even though circulating available androgens have been implicated in several domains of sexual response, they seem to be related weakly to symptoms, such as low sexual desire, poor sexual arousal, orgasm and diminished well-being in postmenopausal women. The possibilities of treating low sexual desire/HSDD are multifaceted and should include the combination of pharmacological treatments able to maximize biological signals driving the sexual response, and individualized psychosocial therapies in order to overcome personal and relational difficulties. Transdermal T has been shown to be effective at a dose of 300 µg/day both in surgically and naturally menopausal women replaced with estrogen or not, without any relevant side-effects. However, the decision to treat postmenopausal women with HSDD with T is mainly based on clinical judgement, after informed consent regarding the unknown long-term risks.
[Show abstract][Hide abstract] ABSTRACT: The aim of the present observational, cross-sectional study was to examine the effects of hormonal and psycho-relational variables on sexual function during menopausal transition and at early postmenopause in women with hot flushes.
The sample comprised 138 women referred to a clinic for the treatment of hot flushes. They were categorised according to their stage of menopausal transition using the STRAW criteria: early menopausal transition (EMT) if their menstrual cycle was 7 or more days different from normal; late perimenopause (LMT) if they had experienced 60 days or more of amenorrhoea; and early postmenopause (EPM) if their amenorrhoea had lasted for at least 12 months but less than 4 years.
Sexual function was measured by using the Female Sexual Function Index (FSFI), while anxiety (state and trait), depression, eating disorder and marital adjustment were evaluated by validated self-report questionnaires. Levels of free testosterone (FT), dehydroepiandrosterone sulfate (DHEAS) and estradiol (E2) were also measured.
Overall sexual function varied significantly with stage of menopause, with total FSFI score less in EPM than in EMT (p=.009). A similar pattern was evident on FSFI sub-scales for sexual desire (p=.02), arousal (p=.01) orgasm (p=.01) and also pain (p=.02), but not for lubrication and satisfaction. Ratings for anxiety, depression and eating disorder did not differ across the menopausal sub-groups, and neither did ratings of marital adjustment. Both FT (p=.01) and DHEAS (p=.03) levels were slightly reduced at EPM in comparison with EMT, as were E2 levels (p=.001 EMT versus LMT; p=.0001 LMT versus EPM). In multiple regression analyses, plasma FT level was the only factor to predict FSFI full score (beta=.48; p=0.004) in women at EMT, while in women at LMT the depression score was the only factor to do so (beta=-.62; p=0.0001). The best model predicting FSFI full score at EPM included levels of DHEAS and E2 levels and state anxiety score.
Hormonal and some psychological variables are relevant to sexual function in symptomatic women during menopausal transition and at early menopause but their role differs with the specific stage of reproductive ageing.
[Show abstract][Hide abstract] ABSTRACT: Hypoactive sexual desire disorder (HSDD) is a common multidimensional condition which is characterized by a decrease in sexual desire that causes marked personal distress and/or interpersonal difficulty. There are a number of potential causes and contributing factors to HSDD and a balanced approach comprising both biological and psycho-relational factors is mandatory for accurate diagnosis and tailored management in clinical practice. It is clearly evident that sex hormones play a crucial role in modulating sexual response during the entire reproductive life span of women. On the other hand, a better understanding of the neurobiological basis of sexual desire supports the idea that selective psychoactive agents may be proposed as non-hormonal treatments to restore the balance between excitatory and inhibitory stimuli leading to a normal sexual response cycle. However, there are currently no approved pharmacological treatments for premenopausal women with HSDD, while transdermal testosterone is approved in Europe for post-menopausal women who experience HSDD as a result of a bilateral oophorectomy. That being so, the ideal clinical approach remains to be established in term of efficacy and safety and further research is needed to develop specific pharmacotherapies for individualized care of women with sexual dysfunction of any age.
Sexual and Relationship Therapy 01/2010; 25(3):264-274. · 0.51 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Hypoactive sexual desire disorder (HSDD) is a common multifactorial condition which is characterized by a decrease in sexual desire that causes marked personal distress and/or interpersonal difficulty. The general idea that HSDD is a sexual dysfunction difficult to treat is due to the large number of potential causes and contributing factors. Indeed, a balanced approach comprising both biological and psycho-relational factors is mandatory for accurate diagnosis and tailored management in clinical practice. There are currently no approved pharmacological treatments for premenopausal women with HSDD, while transdermal testosterone is approved in Europe for postmenopausal women who experience HSDD as a result of a bilateral oophorectomy. Even though the role of sex hormones in modulating the sexual response during the entire reproductive life span of women is crucial, a better understanding of the neurobiological basis of sexual desire supports the idea that selective psychoactive agents may be proposed as nonhormonal treatments to restore the balance between excitatory and inhibitory stimuli leading to a normal sexual response cycle. We conclude that the ideal clinical approach to HSDD remains to be established in term of efficacy and safety, and further research is needed to develop specific hormonal and nonhormonal pharmacotherapies for individualized care in women.
International Journal of Women's Health 01/2010; 2:167-75.
[Show abstract][Hide abstract] 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.
[Show abstract][Hide abstract] ABSTRACT: In this review, we underline the importance of linking migraine to reproductive stages for optimal management of such a common disease across the lifespan of women. Menopause has a variable effect on migraine depending on individual vulnerability to neuroendocrine changes induced by estrogen fluctuations and on the length of menopausal transition. Indeed, an association between estrogen 'milieu' and attacks of migraine is strongly supported by several lines of evidence. During the perimenopause, it is likely to observe a worsening of migraine, and a tailored hormonal replacement therapy (HRT) to minimize estrogen/progesterone imbalance may be effective. In the natural menopause, women experience a more favourable course of migraine in comparison with those who have surgical menopause. When severe climacteric symptoms are present, postmenopausal women may be treated with continuous HRT. Even tibolone may be useful when analgesic overuse is documented. However, the transdermal route of oestradiol administration in the lowest effective dose should be preferred to avoid potential vascular risk.
[Show abstract][Hide abstract] ABSTRACT: Background
Premenstrual Syndrome (PMS) comprises a wide variety of cyclical and recurrent symptoms, including physical, emotional, behavioral and cognitive symptoms that occur during the luteal phase of the menstrual cycle and rapidly resolve with the onset of menstrual bleeding. The lack of a clear diagnostic framework has brought to different epidemiological, etiopathogenetic and clinical conclusions over the years. Premenstrual Dysphoric Disorder (PMDD) is the most severe and disabling form of premenstrual disorder and occurs in 3–8% of cases, including always at least a dysphoric symptom. In some cases, it represents the premenstrual exacerbation of depression/anxiety symptomatology.Discussion and conclusionsPMS/PMDD represent a model of the cyclical psychoneuroendocrine compromise deriving from women's adaptive responses which fluctuate monthly in response to periodic sexual hormone variations throughout the menstrual cycle. The complexity of the syndrome is likely to be related to the peculiar threshold of vulnerability of each woman which is modulated during the reproductive life span by several biological and even psychosocial factors. That being so, symptoms are extremely diverse, no biochemical markers are evident and therapeutic management is not always easy. Estro-progestin preparations for hormonal contraception may represent a suitable treatment strategy.
Quaderni Italiani di Psichiatria. 01/2009; 28(1):27-33.
[Show abstract][Hide abstract] ABSTRACT: Urogenital aging and female sexual dysfunction (FSD) are significant problems following menopause. Estrogen decline is one of the key factors contributing to sexual functioning because of its crucial role for genital arousal (vasocongestion and lubrication) and other domains of the sexual response. Several common medical conditions, including cardiovascular disease (CVD), may interfere with women's sexual response across the aging process. FSD is one of the most common CVD-related quality-of-life complications with a major impact on patients' and their sexual partners' life. There is no evidence that FSD may represent an early indication of cardiovascular risk in postmenopausal women. In spite of the high prevalence, FSD remains largely under-recognized and sexual counseling is an important consideration for the proper management of postmenopausal women with CVD. Many local estrogen products are available (creams, tablets, suppositories, pessaries and rings) and are equally effective for treatment of vaginal atrophy. When a history of CVD is present, local estrogens may be safely used to treat urogenital atrophy with a significant improvement of sexual health and quality of life.
[Show abstract][Hide abstract] ABSTRACT: To investigate domains of sexual function in healthy women attending a gynecological office for routine annual check-up using the Italian translation of the Female Sexual Function Index (FSFI) according to age, reproductive status and hormonal treatments; and to confirm the usefulness of the FSFI in detecting relevant clinical entities.
Of 720 women (age range 18-65 years), 564 (78%) filled in a short anamnestic questionnaire and the FSFI assessing desire, arousal, lubrication, orgasm, satisfaction and pain. A semi-structured DSM-IV-TR clinical interview was administered to a convenience sample of women selected according to the quartile distribution of the median full scale FSFI score. Analysis of data was performed by frequency tables and non-parametric statistics.
The median full scale score of FSFI in our study population was 27.6 (lower quartile: 18.7, upper quartile: 30.9) and the percentage of women under the lower quartile of the distribution was 24.4%. Sexual function decreased progressively with age, being significantly lower after 30 years and after 60 years (chi(2) = 52.6; p = 0.0001). Menopausal women had significantly lower median FSFI full scale score compared with fertile women and women who used oral contraception (OC) (p < 0.0001 for both), while users of hormone replacement therapy (HRT) displayed better overall sexual function than untreated postmenopausal women (p < 0.005). A positive diagnosis of female sexual dysfunction (FSD) was evident only in young women scoring under the lower quartile of the distribution (cut-off score: 23.4 for women not taking OC and 20.8 for OC users), while older women were dysfunctional also above the lower quartile of the distribution (cut-off score: 14.1 for menopause, 18.5 for HRT) of the FSFI full scale score.
The FSFI is a powerful screening tool for FSD, especially in young fertile women, and may be used effectively in routine gynecological practice.
[Show abstract][Hide abstract] ABSTRACT: A significant proportion of women reporting female sexual dysfunction (FSD) suffer from hypoactive sexual desire disorder (HSDD) which is characterized by a loss of sexual desire leading to distress. HSDD is highly prevalent in women of any age, but only in the recent years some research has been conducted to uncover the potential causes and to find therapeutic strategies. A complex interplay of biological, psychological and socio-relational factors is related to women's sexual health during the entire reproductive life span. Menopause is a time of vulnerability to sexual symptoms as a result of sex hormonal changes inducing climacteric syndrome. Vaginal dryness is a common feature significantly affecting genital arousal and, consequently, desire, orgasm and satisfaction. Recently, HSDD has been well described especially in surgical menopause, a clinical condition clearly characterized by the loss of both estrogens and androgens. Therefore, the major focus is on hormonal treatments, in particular the testosterone (T) patch which is able to restore T levels to premenopausal stage with a significant improvement of sexual activity, desire and satisfaction, reducing women’distress both in surgical and natural menopause.
However, there is a medical need to develop novel therapies that can be used even in younger women. A great hope comes from drugs acting on central nervous dopaminergic, serotoninergic and noradrenergic pathways involved in mental drive, arousal and satisfaction.
In any case, hormonal and non hormonal treatments and/or psychosexual strategies should be individualized and tailored on women's history and current needs to counteract the distress associated with HSDD.
[Show abstract][Hide abstract] ABSTRACT: A large number of biological, psycho-relational and socio-cultural factors are related to women's sexual health and they may negatively affect the entire sexual response cycle inducing significant changes in sexual desire, arousal, orgasm and satisfaction during the entire reproductive life span. In spite of the high prevalence of sexual problems with increasing age, sexual retirement is not an inevitable consequence of the passage of time and a high proportion of men and women remains sexually active well into later life, a result of changing attitudes toward sexuality and the availability of effective treatments for sexual dysfunction. Population-based studies reported an age-related decline of sexual functioning and an additional adverse effect of menopausal status. Ageing per se interferes with the level of sexual performance, but sexual behaviour of midlife and older women is highly dependent on several factors such as general physical and mental well-being, quality of relationship and life situation. Sex hormones, mainly low levels of estradiol, are relevant for the lack of sexual awareness and vaginal receptivity in naturally menopausal women. Even diminished levels of androgens, as it more frequently occurs in surgically menopausal women, has a negative impact on desire and sexual responsiveness. Several hormonal treatments have been used locally or systemically to alleviate sexual symptoms, especially by using estrogen plus androgen preparations and tibolone, with noticeable results on drive, enjoyment, lubrication, ability to reach orgasm and initiation of sex. However, sexual counseling and individualized management is mandatory to obtain meaningful and long-lasting results in clinical practice.
[Show abstract][Hide abstract] ABSTRACT: The aim of the present pilot, randomized, study was to assess hemodynamic status of clitoral erectile tissues in postmenopausal women reporting female sexual dysfunction (FSD), namely libido and arousal disorders, under hormone therapy (HT). Vaginal health and sexual function were also investigated.
Fifty patients presenting for clinical evaluation of menopausal status and suffering from FSD were randomly assigned to receive tibolone (2.5 mg) or 1 mg 17beta-estradiol .5 mg NETA (EPT) for 6 months. The observational period lasted 7 months during which women underwent to duplex Doppler ultrasonography to obtain clitoral hemodynamic data, were evaluated by using the vaginal health score index (VHIS) and filled in the two-factor Italian McCoy female sexuality questionnaire (MFSQ).
Tibolone significantly increased clitoral peak systolic and end diastolic velocity (p<.001 for both), while no significant difference was evident in clitoral circulation of women under EPT at the end of the study. Both tibolone and EPT significantly increased VHIS (p<.001), an effect already evident following 3 months of HT. The atrophic state was significantly improved at 6 months (p<.001) with no significant differences between the two HT regimens. After 3 months, both tibolone and EPT significantly increased the sexuality score (p<.001, for both), but such an effect was significantly more pronounced in FSD women treated with tibolone in comparison with those assuming EPT (p<.002). Between the 3rd and the 6th month, tibolone caused a further significant improvement of sexuality score (p<.001), while women under EPT did not show any significant further change displaying a lower score (p<.001) at the end of the study in comparison with women assuming tibolone.
Clitoral circulation in postmenopausal women reporting FSD is significantly increased under tibolone in comparison with EPT with a better improvement of sexual function, as measured by MFSQ, following 6 months of treatment.
[Show abstract][Hide abstract] ABSTRACT: The present randomized prospective study aimed to compare the effect of tibolone (T) with conventional low-dose estrogen-progestogen therapy (EPT) administered in a combined continuous regimen on the course of primary headaches in postmenopausal women requesting hormone therapy (HT) for climacteric complaints.
Forty women presenting for clinical evaluation of headache (migraine without aura and episodic tension-type headache) were enrolled. The observational period lasted 7 months during which women kept a diary of the clinical characteristics of headache attacks and analgesic use. Climacteric symptoms and both anxiety and depression were also measured. After a 1-month run-in period, women received two different HT regimens: 1 mg 17beta-estradiol + 0.5 mg norethisterone acetate (EPT) or 2.5 mg T. Follow-up evaluations were planned after 3 and 6 months of treatment.
Although T did not affect the number of days with migraine without aura, it significantly reduced the number of hours during which pain intensity prohibited daily activities (P < 0.001) and the number of analgesics (P < 0.001) after 3 months. Conventional low-dose EPT administered in a combined continuous regimen was confirmed to have a mild, but negative, effect on the course of migraine without aura by increasing the number of days with head pain (P < 0.001) and the number of analgesics (P < 0.001). Interestingly, both treatments were effective in the management of episodic tension-type headache, significantly reducing the number of days with head pain, severity, and analgesic consumption.
In postmenopausal headache sufferers, analgesics are more effective in alleviating severe head pain when women are treated with T in comparison with low-dose EPT for climacteric complaints.
[Show abstract][Hide abstract] ABSTRACT: The primary objective of this randomized, double-blind, controlled study was the assessment of the pH-lowering effect of three different formulations of a vaginal device each containing 250 mg vitamin C. Overall, 39 women with vaginal pH >or=5, without evidence of vaginal infections, were randomly assigned to receive one of the three formulations for 6 days. The primary parameter assessed was vaginal pH, performed by the physician at the baseline and final visits and by the subjects each day during the application period; secondary parameters included the acceptability and safety profile of the tested devices. A decrease in pH to the normal range in all groups was observed following the first application, with stable low values during the whole study period. No statistically significant differences were seen among the three groups, while statistically significant within-group differences were observed. Acceptability and tolerability were rated as very good/good in most cases. The study results confirm that the vaginal application of vitamin C has an effective and long-lasting vaginal pH-lowering effect.
[Show abstract][Hide abstract] ABSTRACT: Menopause is often associated with vaginal atrophy and related symptoms, such as vaginal dryness, burning, itching, and dyspareunia, decrease in libido and in general a decrease in the quality of life. The common treatment up to the 1990's has been the oral hormone replacement therapy (HRT), but this treatment has been consequently re-considered due to its adverse effects. Topical estrogenic products have been subsequently developed to minimize the systemic adverse effects of the oral HRT, but they are still considered at risk in case of prolonged use. As an alternative, two clinical trials were performed to investigate the effects of a medical device in the form of a gel, containing hyaluronic acid, liposomes, phytoestrogens from Humulus lupulus extract, and Vitamin E, with the aim of testing its safety and efficacy in post-menopausal women with urogenital atrophy. The first pilot study confirmed in 10 women the good safety profile, both locally and systemically, of the device applied on the external genitals at the dose of 1-2 g/day for 30 days. The second study was carried out, according to a multicenter, open, non-controlled design, in 100 post-menopausal women assigned to the vaginal application of 2.5 g of gel/day for 1 week followed by two applications/week for 11 weeks. The primary end-point was the evaluation of vaginal dryness assessed by a Visual Analogue Scale both by the investigator and the subject. Secondary endpoints were the evaluation of all other symptoms and signs associated with atrophic vaginitis (itching, burning, dyspareunia, vaginal inflammation/oedema and rash assessed by a 4-point scale and presence of vaginal abrasions and disepithelialisation), and the recording of adverse events during the study. At the end of the treatment, an overall judgment on the efficacy and safety of the device was made by the investigator and a judgment on the acceptability of the treatment was made by the subjects. The results showed a marked effect of the tested product on the vaginal dryness and on all other symptoms and signs with statistically significant reductions since the first week of treatment. No treatment-related adverse events were complained by the subjects and the treatment course showed a high level of acceptability by the subjects. This device could be considered an effective and safe alternative treatment of genital atrophy in post-menopausal women, especially when HRT is not recommended.