Lucia Di Mari

The function of sildenafil on female sexual pathways: a double-blind, cross-over, placebo-controlled study

OBJECTIVES To determine the changes, if any, on female sexual pathways using sildenafil (primary outcome), and to verify the safety of this drug (second outcome). STUDY DESIGN Following previous research on symptomatic women, we wanted to study the effects of sildenafil on asymptomatic women. We would like to make it clear from the outset that this study is part of an ongoing line of research and this drug, and others of its type, should be used under strict medical supervision only on symptomatic patients. A randomized double-blind cross-over, placebo-controlled study was conducted at the Family Planning Centre of the Group for Sexological Research, Department of Microbiological and Gynecological Science, School of Medicine, University of Catania, Italy. Sixty-eight healthy volunteer women aged 19-38 years, asymptomatic for sexual disorders, were enrolled. The study consisted of 4 weeks sildenafil, 2 weeks washout, and 4 weeks placebo, by two possible sequences: sildenafil 50 mg, washout, placebo; or placebo, washout, sildenafil 50 mg. Efficacy of sildenafil was assessed by the Personal Experiences Questionnaire (PEQ) based on the 5-point Likert scale. The questionnaire quantified subjective sexual aspects at baseline, during washout, after treatments, and at the follow-ups. Statistical analysis was done with the Wilcoxons rank-sum test and Students t-test. RESULTS 50/68 women completed the study at the first follow-up, and 38 women reached the second follow-up. Six women withdrew because of adverse events. Sildenafil improved arousal (P<0.001), orgasm (P<0.05), and enjoyment (P<0.001) with respect to placebo. Significant differences were noted during sildenafil usage with respect to the baseline for arousal (P<0.01), orgasm (P<0.001), and sexual enjoyment (P<0.001). The adverse events were transient and mild or moderate. CONCLUSIONS Our study suggests that sildenafil acts on the different sexual pathways in healthy women, improving their sexual experience. This study could help to understand the physiologic and pathophysiologic aspects of female sexuality. In comparison with current psychosexual therapies, which are long-term, compliance would be improved with use of this drug. Additional studies are required to define the use of sildenafil in a clinical setting.

Effects of patch or gel estrogen therapies on auditory brainstem response in surgically postmenopausal women: a prospective, randomized study

OBJECTIVE To study the effects of gonadal steroids on the nongenital audiological target in surgically postmenopausal women treated with patch or gel transdermal estrogen therapy (ET). DESIGN Prospective randomized study. SETTING Research Group for Sexology, University of Catania, Italy. PATIENT(S) One hundred twenty-two surgically postmenopausal women. INTERVENTION(S) Transdermal E(2) by patch or gel, and evaluation of auditory brainstem response by auditory-evoked potentials for waves I, III, and V latencies, and for interpeak I-III, I-V, and III-V intervals. MAIN OUTCOME MEASURE(S) Changes in auditory wave latencies and in interpeak intervals during treatment with ET with respect to baseline levels. RESULT(S) One hundred two women completed the study. Forty-eight subjects used E(2) patches and 54 E(2) gel. No significant difference was observed in plasma E(2) improvement and in auditory brainstem response values with the two estrogen (E) formulations. The wave latencies and the interpeak intervals showed lower values during the E treatment than at baseline. CONCLUSION(S) Auditory brainstem response seems to depend on the type of E given. Our data suggest that fluctuating E levels act on waves, even if the exact mechanism of the gonadal steroids is not clear. However, we believe that E could influence neuronal plasticity, the metabolic levels of neurotransmitters, and thus, the neuronal conduction time into the audiological system.

Cytologic aspects of the nasal respiratory epithelium in postmenopausal women treated with hormone therapy

OBJECTIVE To investigate the effects of hormone therapy (HT) on nasal respiratory epithelium in postmenopausal women. DESIGN Prospective open clinical trial. SETTING Outpatient menopausal clinic. PATIENT(S) One hundred three healthy postmenopausal women, of whom 55 treated with HT, and 48 untreated women (controls). INTERVENTION(S) Different regimens of HT by patch, gel, or oral administration. MAIN OUTCOME MEASURE(S) Cytologic changes of nasal, middle and inferior turbinate cells compared with vaginal cytologic findings by using the maturation index. RESULT(S) Hematoxylin-eosin staining for the maturation index confirmed similar trophic cytologic aspects between the nasal respiratory epithelium and vaginal smears in HT-treated women and controls. Women treated with sequential HT or estrogen therapy (ET) showed better trophic characteristics in the nasal cytological samples compared with women treated with continuous combined HT. CONCLUSION(S) Along with vaginal cells the nasal respiratory epithelium is an estrogen target. The activity of HT in the nasal respiratory epithelium may depend on the type of hormone regimen used.

Prospective study on the cytological aspects of the nasal respiratory epithelium in premenopausal women taking 30 mcg ethinylestradiol and 3 mg drospirenone oral contraceptive

BACKGROUND This study was conducted to determine the effects of the monophasic oral contraceptive (OC) containing 30 mcg ethinylestradiol (EE) and 3 mg drospirenone (DRSP) on the nasal respiratory epithelium in premenopausal women. STUDY DESIGN Fifty premenopausal women participated in the prospective study. Baseline endovaginal ultrasound examination and blood test to measure serum progesterone to confirm an ovulatory cycle were performed. The cytologic changes on the nasal respiratory epithelium were evaluated with the maturation index, performed during the follicular, periovular and luteal phases of the menstrual cycle, and on the sixth cycle of pill intake. RESULTS The maturation indexes of the nasal smears were higher during both the follicular and periovular phases than during the luteal phase of the menstrual cycle (p<.05). Women on the OC pill had similar changes in the nasal epithelium as those seen during the follicular phase (p NS), and less than the periovular phase (p<.05) and higher than the luteal phase (p<.05). The maturation index of the nasal respiratory epithelium seems to depend on the variation of the ovarian steroids during the menstrual cycle and on the iatrogenic effects of oral contraception. CONCLUSIONS DRSP+EE seems to provoke cytological changes that are different from previously shown gestodene plus EE.