Effect of methyl testosterone administration on plasma viscosity in postmenopausal women A double-blind, randomized, placebo-controlled trial of the effect of testosterone cream on the sexual motivation of menopausal hysterectomized women with hypoactive sexual desire disorder EFFECT OF OESTROGEN AND TESTOSTERONE IMPLANTS ON PSYCHOLOGICAL DISORDERS IN THE CLIMACTERIC Efficacy of vaginally applied estrogen, testosterone, or polyacrylic acid on sexual function in postmenopausal women: a randomized controlled trial. Androgen enhances sexual motivation in females: a prospective, crossover study of sex steroid administration in the surgical menopause. Testosterone patch increases sexual activity and desire in surgically menopausal women with hypoactive sexual desire disorder. Testosterone patch for low sexual desire in surgically menopausal women: a randomized trial. Efficacy and safety of a testosterone patch for the treatment of hypoactive sexual desire disorder in surgically menopausal women: a randomized, placebo-controlled trial The effect of transdermal testosterone on mammographic density in postmenopausal women not receiving systemic estrogen therapy. Testosterone therapy increases sexual desire in ageing men with low–normal testosterone levels and symptoms of androgen deficiency Testosterone treatment of HSDD in naturally menopausal women: the ADORE study Testosterone patch for the treatment of hypoactive sexual desire disorder in naturally menopausal women: results from the INTIMATE NM1 Study Effect of androgens combined with hormone therapy on quality of life in post-menopausal women with sexual dysfunction Safety and efficacy of a testosterone patch for the treatment of hypoactive sexual desire disorder in surgically menopausal women: a randomized, placebo-controlled trial. PERCEIVED EFFECTS OF TESTOSTERONE REPLACEMENT THERAPY IN PERIMENOPAUSAL AND POSTMENOPAUSAL WOMEN: AN INTERNET PILOT STUDY Differential symptom response to parenteral estrogen and/or androgen administration in the surgical menopause. Clinically relevant changes in sexual desire, satisfying sexual activity and personal distress as measured by the profile of female sexual function, sexual activity log, and personal distress scale in postmenopausal women with hypoactive sexual desire disorder. Effect of high-dose isoflavones on cognition, quality of life, androgens, and lipoprotein in post-menopausal women Comparative effects of oral esterified estrogens with and without methyltestosterone on endocrine profiles and dimensions of sexual function in postmenopausal women with hypoactive sexual desire. The endocrine transition around menopause ‐ a five years prospective study with profiles of gonadotropines, estrogens, androgens and SHBG among healthy women Effectiveness of a low dose testosterone undecanoate to improve sexual function in postmenopausal women The effect of hormone replacement therapy and route of administration on selected cardiovascular risk factors in post-menopausal women. Evaluation of the clinical relevance of benefits associated with transdermal testosterone treatment in postmenopausal women with hypoactive sexual desire disorder.
background Coronary heart disease ( CHD ) is the leading cause of mortality in women , with an incidence that increases after menopause , hence suggesting a cardioprotective role of oestrogen . Menopause also results in a decline in and rogen levels with result ing symptoms of decreased libido and sexual dysfunction . Recently , there has been a growing interest in the treatment of postmenopausal women with and rogens . However , no data are available on plasma viscosity and fibrinogen levels in postmenopausal women on combined oestrogen/ and rogen therapy Objectives To assess the safety and efficacy of 10 mg topical testosterone therapy daily ( 2 cm And ro-Feme ® cream ) as a treatment for low sexual desire in postmenopausal hysterectomized women who were already on transdermal estrogen . Methods A double-blind , r and omized , placebo-controlled , cross-over study ( each period being of 3 months ' duration ) was performed in the research center of a tertiary referral women 's hospital . Thirty-six menopausal healthy women were recruited who had undergone a hysterectomy , who were not depressed , were in a stable relationship and who fulfilled diagnostic criteria for low sexual desire , as measured by the Brief Index of Sexual Function for Women ( BISF-W ) . Main outcome measures The primary outcome measure was improvement in the sexuality score as measured by a vali date d tool ( BISF-W ) ; secondary measures were sub-scores of the BISF-W , effect on mood and energy , lipids and testosterone levels .  Results Testosterone cream significantly improved sexual desire , frequency of sex , receptivity and initiation as measured by the BISF-W score . It did not change mood , energy , lipids , blood pressure or weight over the study period . Conclusions Testosterone cream significantly improved sexual scores in menopausal women with low sexual desire . It was effective , easy to use and had no side-effects over the 3-month period of active treatment . It offers a novel and acceptable method of administering testosterone to menopausal women In a double-blind trial oestradiol , oestradiol/testosterone , or placebo implants were assessed for their effects on psychological symptoms in women attending a menopause clinic . After two months , women receiving active treatment scored better than the placebo group on a self-rating scale of distress , on anxiety , and on depression ( p less than 0.05 ) . Postmenopausal but not perimenopausal women improved after placebo , and at 4 months the scores in the three groups no longer differed significantly INTRODUCTION Female libido is multifactorial and complex . Declining estrogen levels in postmenopausal women affects vaginal function . AIM The aim of this study was to evaluate female sexual function after using topical estrogen , testosterone , or polyacrylic acid as vaginal lubricants with K-Y jelly as a placebo lubricant . METHODS This was a r and omized controlled clinical trial on 80 postmenopausal women between 40 and 70 years of age with follow-up at the Menopause Clinic of the CAISM Unicamp . The women were r and omized to treatment with topical vaginal estrogen , testosterone , polyacrylic acid , or oil lubricant alone , three times a week for a period of 12 weeks from November 2011 to January 2013 . MAIN OUTCOME MEASURE We used the Female Sexual Function Index ( FSFI ) to assess changes in sexual response at baseline , and after 6 and 12 weeks . RESULTS After 12 weeks of treatment , polyacrylic acid and topical testosterone produced improvements in the FSFI domains of sexual desire , lubrication , satisfaction , reduced pain during intercourse , and total score compared with lubricant alone . Treatment with topical estrogen in comparison with lubricant alone showed an improvement in the FSFI field of desire . The intragroup analysis over the time of the treatment showed improvements in the fields of desire , lubrication , and reduced pain for polyacrylic acid , testosterone , and estrogen . Furthermore , women who used testosterone showed improvements over time in the fields of arousal , orgasm , and satisfaction . CONCLUSIONS Treatment of postmenopausal women with symptoms of vaginal atrophy with polyacrylic acid , testosterone , and estrogen for 12 weeks produced improvements in self-reported female sexual function when compared with a placebo lubricant & NA ; Various parameters of sexual functioning were assessed in a prospect i ve , crossover investigation of 53 surgically menopausal women . Patients r and omly received either an estrogen‐ and rogen combined preparation , an estrogen‐alone drug , an and rogen‐alone drug , or a placebo .  Also included were a group of women who had undergone hysterectomy and whose ovaries had been left intact . Two treatment phases , each of 3 months ' duration , were separated by an intervening placebo month . Additionally , plasma levels of total estrogens and testosterone were assayed four times during the study concurrent with monitoring of sexual behaviors . It was clear that exogenous and rogen enhanced the intensity of sexual desire and arousal and the frequency of sexual fantasies in hysterectomized and oophorectomized women . However , there was no evidence that testosterone affected physiologic response or interpersonal aspects of sexual behavior . These findings suggest that the major impact of and rogen in women is on sexual motivation and not on sexual activity per se CONTEXT Hypoactive sexual desire disorder ( HSDD ) is one of the most common sexual problems reported by women , but few studies have been conducted to evaluate treatments for this condition . OBJECTIVE The objective of this study was to evaluate the efficacy and safety of a testosterone patch in surgically menopausal women with HSDD . DESIGN The design was a r and omized , double-blind , parallel-group , placebo-controlled , 24-wk study ( the Intimate SM 1 study ) . SETTING The study was performed at private or institutional practice s. PATIENTS The subjects studied were women , aged 26 - 70 yr , with HSDD after bilateral salpingo-oophorectomy who were receiving concomitant estrogen therapy . Placebo ( n = 279 ) or testosterone 300 microg/d ( n = 283 ) was administered . There were 19 patients who withdrew due to adverse events in the placebo group and 24 in the 300 mug/d testosterone group . INTERVENTION Testosterone ( 300 microg/d ) or placebo patches were applied twice weekly . MAIN OUTCOME MEASURE(S ) The primary end point was the change in the frequency of total satisfying sexual activity at 24 wk . Secondary end points included other sexual functioning end points and safety assessment s. RESULTS At 24 wk , there was an increase from baseline in the frequency of total satisfying sexual activity of 2.10 episodes/4 wk in the testosterone group , which was significantly greater than the change of 0.98 episodes/4 wk in the placebo group ( P = 0.0003 ) . The testosterone group also experienced statistically significant improvements in sexual desire and a decrease in distress . The overall safety profile was similar in both treatment groups . CONCLUSION In the Intimate SM 1 study , the testosterone patch improved sexual function and decreased distress in surgically menopausal women with HSDD and was well tolerated in this trial OBJECTIVE To assess the efficacy and safety of a 300 mug/d testosterone patch for the treatment of hypoactive sexual desire disorder in surgically menopausal women on concomitant estrogen therapy . METHODS Five hundred thirty-three women with hypoactive sexual desire disorder who had undergone previous hysterectomy and bilateral oophorectomy were enrolled in a 24-week , multicenter , double-blind , placebo-controlled trial . Patients were r and omly assigned to receive placebo or the testosterone patch twice weekly . The primary efficacy endpoint was change from baseline at week 24 in the frequency of total satisfying sexual activity , measured by the Sexual Activity Log . Secondary measures included sexual desire using the Profile of Female Sexual Function and personal distress as measured by the Personal Distress Scale . Hormone levels , adverse events , and clinical laboratory measures were review ed . RESULTS Total satisfying sexual activity significantly improved in the testosterone patch group compared with placebo after 24 weeks ( mean change from baseline , 1.56 compared with 0.73 episodes per 4 weeks , P = .001 ) . Treatment with the testosterone patch also significantly improved sexual desire ( mean change , 10.57 compared with 4.29 , P < .001 ) and decreased personal distress ( P = .009 ) . Serum free , total , and bioavailable testosterone concentrations increased from baseline . Overall , adverse events were similar in both groups ( P > .05 ) . The incidence of and rogenic adverse events was higher in the testosterone group ; most and rogenic adverse events were mild . CONCLUSION In surgically menopausal women with hypoactive sexual desire disorder , a 300 mug/d testosterone patch significantly increased satisfying sexual activity and sexual desire , while decreasing personal distress , and was well tolerated through up to 24 weeks of use Objective : Evaluation of the use of testosterone therapy for hypoactive sexual desire disorder ( HSDD ) after oophorectomy has mostly involved women treated with oral estrogen preparations . We investigated the efficacy and safety of a testosterone patch in surgically menopausal women receiving concurrent transdermal estrogen . Design : Women with HSDD after oophorectomy , for whom this was a concern , who were using transdermal estrogen , were recruited to a 24-week , r and omized , double-blind , placebo-controlled  trial in Europe and Australia . Patients were r and omly allocated to placebo ( n = 40 ) or testosterone 300 & mgr;g/day ( n = 37 ) treatment . Primary endpoints were changes in sexual desire measured by the sexual desire domain of the Profile of Female Sexual Function and the frequency of satisfying sexual activity at 24 weeks . Results : Sixty-one women ( 79 % ) completed the trial . All subjects who received at least one application of study medication were included in analysis . The testosterone-treated group experienced a significantly greater change from baseline in the domain sexual desire score compared with placebo ( change from baseline , 16.43 versus 5.98 ; P = 0.02 ) . The domain scores for arousal , orgasm , decreased sexual concerns , responsiveness , and self-image as well as decreased distress were also significantly greater with testosterone therapy than placebo . The frequency of satisfactory sexual events increased but was not statistically different between treatment groups ( P = 0.06 ) Adverse events occurred with similar frequency in both groups , and no serious risks of therapy were observed Conclusions : In this study , transdermal testosterone therapy via a skin patch improved sexual desire and other sexual function domains . It was well tolerated in these oophorectomized women with HSDD receiving concomitant transdermal estrogen CONTEXT Greater mammographic density is associated with increased breast cancer risk and reduced diagnostic mammographic sensitivity and may be seen with estrogen/progestin therapy ( EPT ) . The effects of testosterone therapy on mammographic density in postmenopausal women not on EPT are not known . OBJECTIVE Our objective was to compare effects of two doses of the testosterone transdermal patch ( TTP ) with placebo in postmenopausal women without concomitant EPT on mammographic density  over 52 wk . DESIGN We conducted a r and omized , double-blind , placebo-controlled , parallel-group , multinational trial . PATIENTS Patients included 279 postmenopausal women participating in a testosterone and sexual function study with paired mammograms for baseline and 52 wk/exit . INTERVENTIONS Patients were r and omized to placebo , TTP 150 microg/d , or TTP 300 microg/d , stratified by menopause type ( natural or surgical ) . MAIN OUTCOME MEASURES Change from baseline to wk 52 in the percentage of dense tissue ( PD ) on digital mammograms . RESULTS A total of 250 women with paired mammograms for study baseline and wk 52 were included in the primary analysis . Mean age was 54.6 yr , baseline body mass index was 27.5 kg/m(2 ) , and 78 % were naturally menopausal . There were no baseline differences between groups . Mean changes from baseline ( + /-SEM ) in PD for placebo , TTP 150 microg/d and TTP 300 microg/d were small ( 0.05 + /- 0.16 , 0.06 + /- 0.19 , and 0.21 + /- 0.17 % ) and not significantly different . There were no statistically significant differences from placebo for total dense or nondense area and no significant relationships between hormone levels and PD after adjustment for body mass index . CONCLUSION TTP therapy over 52 wk appears to have no significant effect on digitally quantified absolute or percent dense mammographic area in postmenopausal women not using EPT Although decline in sexual function is a common reason for ageing men to seek advice regarding testosterone therapy , placebo-controlled trial data have been unable to show a consistent , beneficial role for testosterone . The objective of this study was to determine the effect of testosterone therapy on sexual function in non-obese ageing men with symptoms of and rogen deficiency and low – normal serum testosterone levels . A total of 60 men aged 55 years or older in good general health with total testosterone ( TT ) levels < 15 nM , and with symptoms suggestive of and rogen deficiency , were r and omized in a double-blinded protocol to transdermal testosterone patches or placebo for 12 months  . Sexual function was assessed using the International Index of Erectile Function at weeks 0 , 26 and 52 . In men receiving testosterone TT levels increased by 30 % ( P=0.01 ) and luteinizing hormone decreased by 50 % ( P<0.001 ) . Relative to placebo , testosterone therapy improved sexual desire ( P=0.04 ) ; however other parameters of sexual function including erectile function were unaffected by the treatment . Ageing men in good general health and with symptoms of and rogen deficiency and low – normal serum testosterone levels receiving 12 months of transdermal testosterone therapy experienced , relative to placebo , improved sexual desire but no effect on other parameters of sexual function Objective To evaluate the efficacy and safety of a transdermal testosterone patch ( TTP , 300 μg/day ) in naturally menopausal women with hypoactive sexual desire disorder ( HSDD ) . Methods A total of 272 naturally menopausal women , predominantly not using hormone therapy , were r and omized in this 6-month , placebo-controlled , double-blind , multicenter study to receive twice weekly either TTP or an identical placebo . Efficacy endpoints measured were the 4-week frequency of satisfying sexual episodes ( SSE ) using the Sexual Activity Log , the sexual desire domain of the Profile of Female Sexual Function and distress by the Personal Distress Scale . Safety was assessed by adverse events , laboratory parameters and hormone levels . Results The TTP group demonstrated significant improvements in SSE ( p = 0.0089 ) as well as in sexual desire ( p = 0.0007 ) and reduced personal distress ( p = 0.0024 ) versus placebo at 6 months ( intent-to-treat analysis , n = 247 ) . The results were significant for all three endpoints in the subgroup ( n = 199 ) not using hormone therapy . Similar numbers of women treated with placebo and TTP discontinued ( n = 39 , 27.5 % vs. n = 26 , 20 % ) , reported adverse events ( including application site reactions ) ( n = 101 , 71.1 % vs. n = 81 , 62.3 % ) and withdrew due to adverse events ( n = 20 , 14.1 % vs. n = 9 , 6.9 % ) . No clinical ly relevant changes were noted in laboratory parameters . Serum free and total testosterone levels increased from baseline in the TTP group ( geometric means 5.65 pg/ml and 67.8 ng/dl , respectively , at week 24 ) within the physiological range ; no changes were seen in estradiol and sex hormone binding globulin levels . Conclusions TTP was effective in treating HSDD and improving sexual function in this study of naturally menopausal women with and without concurrent hormone therapy Objective : To evaluate the efficacy and safety of a testosterone patch for the treatment of women with hypoactive sexual desire disorder after natural menopause . Design : A multicenter , r and omized , double-blind , placebo-controlled , parallel-group trial was conducted in naturally menopausal women with hypoactive sexual desire disorder receiving a stable dose of oral estrogen with or without progestin ( N = 549 ) . Women were r and omized to receive testosterone 300 & mgr;g/day or placebo patches twice weekly for 24 weeks . The primary efficacy measure was change from baseline in frequency of total satisfying sexual activity over a 4-week period ( weeks 21 - 24 ) . Results : A total of 483 women ( 88 % ) were included in the primary analysis population ( those with baseline sex hormone binding globulin levels ≤160 nmol/L ) . The change from baseline in number of total satisfying sexual episodes was significantly greater for testosterone compared with placebo ( participants with baseline sex hormone binding globulin levels ≤160 nmol/L , mean change of 2.1 ± 0.28 versus 0.5 ± 0.23 episodes/4 weeks ; P < 0.0001 ; intent-to-treat population , mean change from baseline of 1.9 ± 0.26 versus 0.5 ± 0.21 episodes/4 weeks , P <  0.0001  ) . Testosterone also produced statistically significant improvements  compared with placebo in all secondary efficacy measures , including sexual desire and personal distress . The testosterone patch was well tolerated . Conclusions : Testosterone patch treatment increased the frequency of satisfying sexual activity and sexual desire , decreased personal distress , and was well tolerated in naturally menopausal women with hypoactive sexual desire disorder Aim . To evaluate with vali date d instruments changes in quality of life and sexuality in women receiving hormonal replacement therapy ( AHT ) .  Design . R and omised , double-blind , double-dummy study with two parallel treatment arms . Patients and methods . Forty-seven healthy post-menopausal women , aged 45–64 years , were evaluated using the Female Sexual Function Index ( FSFI ) and the menopause-specific quality of life question naire ( MENQOL ) . Of them , 40 diagnosed with sexual dysfunction were r and omised ( 1:1 ) to receive daily 0.625 mg of conjugated estrogens plus 1.25 mg of methyl-testosterone and 100 mg of micronised progesterone or placebo . After 3 months follow-up , FSFI and MENQOL question naires were administered for a second time . Results . Quality of life was unchanged in the placebo group whereas AHT significantly improved scores of vasomotor , psychological , physical and sexual symptoms . As expected , FSFI was not modified in the placebo group while in AHT group the FSFI score improved significantly . In addition , at the end of the study , 68.7 % of subjects of the AHT group did not fit did not fit the criteria for sexual dysfunction as per the FSFI ( p < 0.0001 ) . Conclusions . Adding methyl-testosterone to hormone therapy  improves quality of life and sexuality in post-menopausal women with sexual dysfunction BACKGROUND Oophorectomy reduces serum testosterone levels . We studied the efficacy and safety of transdermal testosterone in treating hypoactive sexual desire disorder in surgically menopausal women . METHODS A 24-week , r and omized , double-blind , placebo-controlled , parallel-group , multicenter trial was conducted in women ( aged 24 - 70 years ) who developed distressful low sexual desire after bilateral salpingo-oophorectomy and hysterectomy and who were receiving oral estrogen therapy .  Women were r and omized to receive placebo ( n = 119 ) or testosterone patches in dosages of 150 microg/d ( n = 107 ) , 300 microg/d ( n = 110 ) , or 450 microg/d ( n = 111 ) twice weekly for 24 weeks . Sexual desire and frequency of satisfying sexual activity were primary efficacy outcome measures . RESULTS Of the 447 women r and omized , 318 ( 71 % ) completed the trial . Compared with placebo , women receiving the 300-microg/d testosterone patch had significantly greater increases from baseline in sexual desire ( 67 % vs 48 % ; P = .05 ) and in frequency of satisfying sexual activity ( 79 % vs 43 % ; P = .049 ) . The 150-microg/d group showed no evidence of a treatment effect . The 450-microg/d group also was not statistically different from the 300-microg/d or placebo groups . Marginally significant linear dose-response trends were observed for total satisfying sexual activity and sexual desire at 24 weeks ( P = .06 and .06 , respectively ) . Adverse events occurred with similar frequency in both groups ; no serious safety concerns were observed . CONCLUSIONS The 300-microg/d testosterone patch increased sexual desire and frequency of satisfying sexual activity and was well tolerated in women who developed hypoactive sexual desire disorder after surgical menopause Women experience somatic , mood , energy , and libido changes during menopause .  Testosterone replacement therapy is being prescribed in conjunction with estrogen replacement therapy ( ERT ) for these symptoms . Little is known about women ’s perceptions of the benefits and risks of testosterone , so an Internet survey was conducted to elicit women ’s perceptions of the effects on mood , energy , sexuality , and somatic symptoms .  A sample of 61 women primarily from the United States and Canada participated in the survey ; one woman from Germany and one from Sweden also took part in the survey . Participants reported significantly improved sexuality and improved mood and vigor , with a decline in fatigue . Of the 7 somatic complaints assessed , improvements were noted in 5 ( sleep disturbances , hot flashes , night sweats , vaginal dryness , and appetite ) . A prospect i ve clinical trial is needed to confirm these results The investigation of estrogen and /or and rogen administration on physical and psychological symptoms in the surgical menopause was carried out in a prospect i ve , double-blind , crossover design . When patients who received either a combined estrogen- and rogen drug or and rogen alone  were compared with those who received estrogen alone or placebo , energy level , well-being , and appetite were increased ( p less than 0.01 ) . The and rogen-containing preparations also induced lower somatic , psychological , and total scores on the menopausal index . Superior functioning in the and rogen-treated groups occurred in association with higher plasma testosterone levels during the treatment phases ( p less than 0.01 ) . These data suggest that reduced levels of circulating testosterone subsequent to bilateral oophorectomy may play an important role in the development of physical and psychological symptoms that are frequent sequelae of this surgical procedure INTRODUCTION Transdermal testosterone patch ( TTP ) treatment produced statistically significant improvements in a satisfying sexual activity ( SSA ) , sexual desire , and personal distress in postmenopausal women suffering from hypoactive sexual desire disorder ( HSDD ) , but clinical significance of these changes was not determined . AIM To quantify the magnitude of change in three principal outcomes measures determined by HSDD patients as associated with the perception of meaningful benefit with TTP therapy . METHODS The criteria for defining responders were determined using anchoring methodology and receiver operating characteristics analysis to establish minimum important differences ( MIDs ) in a representative sub sample of 132 patients in two r and omized , controlled trials in surgically menopausal women with HSDD ( N = 1,094 ) . Perceived benefit was established based upon the question " Overall , would you say that you experienced a meaningful benefit from the study patches ? " . These data defined responders and established MIDs for changes in sexual desire , SSA , and personal distress . The MIDs were applied to the two trials to establish responder rates in each treatment group . MAIN OUTCOME MEASURES Changes in score that correspond to the MID for sexual desire , SSA , and personal distress , and responder rates in each treatment group based upon these values . RESULTS Increases in frequency of SSA of greater than 1 activity/4 weeks , increases in sexual desire score of > or = 8.9 , and decreases in the personal distress score of > or = 20.0 were identified as threshold improvements best able to differentiate responders and nonresponders . The responder rate was significantly higher ( P < 0.001 ) in the testosterone group vs. placebo for all three outcomes measures ( sexual desire , 50 % vs. 34 % ; SSA , 44 % vs. 30 % ; personal distress , 51 % vs. 39 % ) . CONCLUSIONS Changes in sexual desire , SSA , and personal distress observed with TTP treatment in surgically menopausal women with HSDD were clinical ly significant and were associated with a meaningful treatment benefit Context : Recent interventional studies indicate that post-menopausal hormone replacement therapy is associated with an increased risk of cardiovascular mortality and breast cancer .  Isoflavones , a class of plant estrogens , have structural similarities to estradiol . Hence , isoflavones may exert beneficial estrogenic health effects in postmenopausal women with fewer adverse effects . Objective : To evaluate the effect of high-dose isoflavones on self-reported quality of life ( QOL ) , cognition , lipoproteins and and rogen status in post-menopausal women . Design and subjects : Double-blind , r and omized , placebo-controlled , 12-week trial of 93 healthy , ambulatory , post-menopausal women ( mean age 56 yr ) . The study was conducted at a tertiary care center in the United States . Intervention : Participants were r and omly assigned to receive 20 g of soy protein containing 160 mg of total isoflavones vs taste-matched placebo ( 20 g whole milk protein ) . Both soy and the placebo were provided in the form of a powder to be mixed with beverages . Main outcome measures : QOL was judged by the Menopause-specific Quality of Life ( MENQOL ) question naire while cognitive function was assessed with st and ard instruments . Total , free , and bioavailable testosterone , gonadotropins , SHBG , and fasting lipids were measured . Results : Eighty-four women ( 90 % ) completed the study ( active=38 , placebo=46 ) . There was a significant improvement in all 4 QOL subscales ( vasomotor , psychosexual , physical , and sexual ) among the women taking isoflavones , while no changes were seen in the placebo group . No significant changes in cognition , serum and rogens or plasma lipids were seen within any of the groups . However , at the end of the study , a group-by-time interaction was observed such that total testosterone and HDL levels were significantly lower in the isoflavones compared to placebo groups . Conclusion : High-dose isoflavones is associated with improved QOL among women who have become menopausal recently . Hence , the timing of isoflavone supplementation with regards to the onset of menopause appears to be important . The use of isoflavones , as an alternative to estrogen therapy , may be potentially useful and seemingly safe in this group of women who are looking for relief from menopausal symptoms OBJECTIVE In some women , a decline in sexual interest accompanies a relative and rogen insufficiency after menopause . We sought to characterize the hormonal effects of the combination of oral esterified estrogens and methyltestosterone and to investigate whether this regimen improves hypoactive sexual desire . DESIGN Double-blind r and omized trial . SETTING Healthy volunteers in a multicenter research environment . PATIENT(S ) Postmenopausal women taking estrogen therapy who were experiencing hypoactive sexual desire . INTERVENTION(S ) 4 months of treatment with 0.625 mg of esterified estrogens ( n = 111 ) or the combination of 0.625 mg of esterified estrogens and 1.25 mg of methyltestosterone ( n = 107 ) . MAIN OUTCOME MEASURES Baseline and end-of- study measurements of total and bioavailable testosterone and sex hormone-binding globulin ( SHBG ) , and mean change in level of sexual interest or desire as rated on the Sexual Interest Question naire . RESULT ( S ) Treatment with the combination of esterified estrogens and methyltestosterone significantly increased the concentration of bioavailable testosterone and suppressed SHBG . Scores measuring sexual interest or desire and frequency of desire increased from baseline with combination treatment and were significantly greater than those achieved with esterified estrogens alone . Treatment with the combination was well tolerated . CONCLUSION ( S ) Increased circulating levels of unbound testosterone and suppression of SHBG provide a plausible hormonal explanation for the significantly improved sexual functioning in women receiving the combination of esterified estrogen and methyltestosterone OBJECTIVE The purpose of this study was to investigate the hormonal changes during the menopausal transition in a non- clinical population . METHODS Fifty-nine healthy Norwegian women participated in a five year prospect i ve longitudinal study during the transition from pre- to post-menopause , starting one to four years before menopause , and ending one to four years postmenopausal . None of these women were given hormone replacement therapy ( HRT ) . Blood sample s were collected every 12 months and luteinizing hormone ( LH ) , follicle stimulating hormone ( FSH ) , steroid hormone binding globuline ( SHBG ) , prolactin ( PRL ) , estradiol ( E2 ) , estrone ( E1 ) , testosterone , and rostendione , dehydroepi and rostendione-sulphate ( DHEA-S ) , and thyroid stimulating hormone ( TSH ) were analyzed . RESULTS The serum levels of FSH and LH , E2 and E1 profile essentially confirmed previous data obtained in cross-sectional studies . A continuous increase in serum FSH and LH and a concomitant fall in E2 and E1 were observed in all women before menopause and in the two postmenopausal years . Both and rostendione and testosterone showed a decline three years before menopause . After the menopause , however , there were fluctuations in the testosterone levels . And rostendione correlated positively with both E2 and E1 and testosterone postmenopausally . Body mass index ( BMI ) did correlate with testosterone , but not with and rostendione . BMI correlated negatively with SHBG . No correlation was found between BMI and E2 , E1 , FSH and LH . CONCLUSION This longitudinal prospect i ve study of hormonal changes during the transition from pre- to postmenopause indicates that not only estrogen hormonal changes , but and rogen hormonal changes as well , precedes the menopause by several years Background Adding testosterone to hormonal therapy could improve sexual function and general well-being among women during climacteric . We evaluated the effectiveness of testosterone undecanoate on sexual function in postmenopausal women utilizing the st and ardized question naire FSFI score . Methods Postmenopausal women with sexual complaints and Female Sexual Function Index ( FSFI ) ≤ 26.5 were enrolled in to this r and omized , double-blinded , placebo-controlled trial . Participants were r and omly assigned to 8-week treatment with either oral testosterone undecanoate 40 mg or placebo twice weekly with daily oral estrogen .  The FSFI scores before and after treatment were compared to assess any improvement of sexual function . Results Seventy women were recruited of which each group had 35 participants . The baseline characteristics and baseline FSFI scores were comparable between both groups . After 8 weeks of treatment , the FSFI scores significantly improved in both groups when compared to the baseline but the FSFI scores from the testosterone group were significantly higher than in the placebo group post-treatment ( 28.6 ± 3.6 , 25.3 ± 6.7 , respectively , p = 0.04 ) . There was no difference in adverse effect between the two groups Conclusions The twice weekly addition of testosterone undecanoate to daily oral estrogen was associated with a significant improvement in sexual function  among postmenopausal women than the use of the estrogen alone . Trial registration Clinical Trials.gov Identifier NCT01724658 ( February 17 , 2012 ) BACKGROUND There is increasing use of hormone replacement therapy ( HRT ) by post-menopausal women . Observational epidemiological studies have shown reductions in cardiovascular risk factors in  HRT users in the USA , but no r and omized controlled trials of HRT have been carried out in the primary practice setting . Previous studies of cardiovascular risk factors have shown a variety of responses according to type of progestagen and oral or topical administration . None has examined the effect of route using an identical progestagen . OBJECTIVES Our aim was to establish differences , if any , in alteration in cardiovascular risk factors with HRT in post-menopausal women according to route of administration of HRT , oral , transdermal and implant , using first oestrogen alone then oestrogen plus norethisterone , or testosterone for implant . METHODS Subjects were recruited by letter of invitation to women aged 50 - 65 years from lists in general practice s local to the Charing Cross Hospital Lipid Clinic in West London . Their menopausal status was confirmed and they were r and omized to one of three treatment groups or acted as controls . They attended for three visits ; at baseline , HRT was initiated as oestrogen alone , oral or transdermal . At the 3-month visit , HRT with the progestagen , norethisterone , was given cyclically , continuously or transdermally until the final visit at 6 months . A separate group of women from the menopause clinic at Chelsea and Westminster Hospital were studied on oestrogen implant then on implanted oestrogen and testosterone . The outcome measures studied were the separate effects of the four regimes as compared with controls on lipoproteins , glucose , insulin , fibrinogen , factor VII and E-selectin , together with weight , waist : hip ratio and blood pressure . RESULTS The continuous combined oestrogen-progestagen therapy had similar effects on cardiovascular risk factors as oestrogen with cyclical progestagen . All regimes lowered low-density lipoprotein cholesterol , the oral route being more potent than the parenteral ; the effect of transdermal HRT was similar to the implant . Lp(a ) was reduced only with the oral route . Reductions in factor VII and E-selectin were observed in both the oral and transdermal routes . There was no increase in body mass index , waist : hip ratio , blood pressure or glucose and insulin levels with any of the HRT regimes used . Systolic blood pressure was reduced with the transdermal route . CONCLUSIONS This study supports the evidence that oestrogen-progestagen HRT , both oral and transdermal , although attenuating some of the benefit of oestrogen alone on fibrinogen and high-density lipoprotein , significantly reduces cardiovascular risk factors , which should diminish post-menopausal risk of coronary disease INTRODUCTION Postmenopausal women with hypoactive sexual desire disorder ( HSDD ) experienced statistically significant improvements in the frequency of satisfying sexual activity , sexual desire , and distress with testosterone treatment in phase III trials , but it was not known whether the magnitude of these effects was clinical ly meaningful . The clinical relevance study was design ed to answer this question . AIM To evaluate the clinical relevance of the treatment benefits . METHODS This study involved a representative sample of 132 surgically postmenopausal women with HSDD who were enrolled in two r and omized , placebo-controlled trials ( N = 1094 ) assessing the efficacy and safety of transdermal testosterone treatment ( 300 mcg/day ) for 6 months . At the end of the studies , prior to unblinding , a sample of women ( 12 % ) was interviewed concerning their experiences with the treatment . MAIN OUTCOME MEASURES Women were asked " Overall , would you say that you experienced a meaningful benefit from the study patches ? " Changes in the efficacy end points in the double-blind studies were compared for the women who did and did not experience an overall meaningful benefit . RESULTS Overall , 33 of 64 women ( 52 % ) who received testosterone reported experiencing a meaningful treatment benefit , compared with 21 of 68 women ( 31 % ) who received placebo ( P = 0.025 ) . Among the women who identified themselves as experiencing a meaningful benefit , the mean ( SE ) change from baseline in 4-week frequency of satisfying sexual activity was 4.4 ( 0.76 ) , in desire score was 21.0 ( 2.78 ) , moving from " seldom " to " sometimes " feeling sexual desire , and in distress score was -36.5 ( 3.96 ) , moving from " often " to " seldom " being distressed . Among the women who identified themselves as not experiencing a meaningful benefit , the mean ( SE ) change from baseline in 4-week frequency of satisfying sexual activity was 0.5 ( 0.31 ) , in desire score was 2.9 ( 1.42 ) , and in distress score was -8.8 ( 2.23 ) . CONCLUSIONS Surgically menopausal women with HSDD in these studies received clinical ly meaningful benefits , including improvements in satisfying sexual activity , sexual desire , and personal distress
Some studies suggest that testosterone therapy has additional effects , which include increased bone mineral density and decreased serum high-density lipoprotein ( HDL ) cholesterol .
The clinical sequelae of oestrogen deficiency during menopause are undoubted .
However , the pathophysiological role of testosterone during the menopause is less clear .
Several r and omized , placebo-controlled clinical trials suggest that testosterone therapy improves sexual function in postmenopausal women .