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The long-term effects of tibolone on libido in surgically postmenopausal women
Tuesday, October 19, 2004 2:45 P.M.
demonstrate improved sexual function with testosterone treatment in naturally menopausal women. These findings are consistent with results from Phase III studies in surgically menopausal women. O-194
Hypoactive sexual desire disorder in menopausal women in the US. S. R. Leiblum, P. E. Koochaki, C. A. Rodenberg. UMDNJ-Robert Wood Johnson Medical School, Piscataway, NJ; Procter and Gamble Pharmaceuticals, Mason, OH.
Tuesday, October 19, 2004 2:30 P.M. O-193 The long-term effects of tibolone on libido in surgically postmenopausal women. L. Tutuncu, A. R. Ergur, E. Mungen, M. Muhcu, Y. Z. Yergok. GMMA, Haydarpasa Training Hospital, Istanbul, Turkey. OBJECTIVE: Many surgically postmenopausal women have decreased libido, sexual activity and pleasure. The effect of hormone therapy on sexual function is controversial. We conducted a study to determine the long-term efficacy of tibolone on sexual function in surgically postmenopausal women. DESIGN: Prospective, observational, open, clinical study. MATERIALS AND METHODS: We studied 116 healthy women, 41 to 55 years old (48.40 ⫾ 3.84) who received tibolone 2.5 mg/day (Livial™ Organon, Turkey) orally for 4 years (Treatment group). Another 94 women, 40 to 57 years old (49.06 ⫾ 4.52) who didn’t want to start any kind of hormone therapy received calcium 1000 mg/day (Control group). All study participants had been in a monogamous, heterosexual relationship for at least 5 years and undergone hysterectomy and bilateral salpingo-oophorectomy not more than 1 year ago. At baseline and after each year of treatment, patients were asked to complete a questionnaire consisting of the first 7 questions of McCoy’s Sex Scale Questionnaire. In this questionnaire each answer was given a value from 1 to 7. The scoring for each of the 7 questions was analyzed separately and then all the scores were added together to give a total score. Groups were compared to each other with this questionnaire at baseline and after 1, 2, 3 and 4 years. Statistical analyses were performed with using Wilcoxon test, Mann-Witney’s U test and student’s t-test. A P value of ⬍0.05 was considered statistically significant. RESULTS: Eighty five patients on treatment group and sixty patients on control group completed the study. Treatment and control group were comparable with regard to demographic characteristics and baseline sexual function parameters. Statistically significant improvement was seen after 1 year compared to baseline in each score obtained from seven questions assessing sexual function and total score of the questionnaire in the tibolone receiving group (p⬍0.05). This improvement was maintained until the end of 4 years. On the other hand none of the 7 parameters in control group had improved after 1 year and conversely bothersome sexual problems were persisted after 2, 3 and 4 years. When treatment group was compared to control group higher scores were found regarding all questions in favor of tibolone treatment at first year and these differences were still statistically significant after 4 years. Significant weight gain was observed after 1 year in the tibolone group compared with the control group and this significance persisted until the end of 4 years. The incidences of other adverse events were similar in both groups. CONCLUSION: The results suggest that tibolone 2.5 mg/day has beneficial long-term effects on libido and sexual life in women who have undergone hysterectomy and bilateral salpingo-oophorectomy. Tibolone can be a good long-term alternative for sexual problems in surgically postmenopausal women. Supported by: None.
S78
Abstracts
OBJECTIVE: (1) Determine the proportion of menopausal women with Hypoactive Sexual Desire Disorder (HSDD); (2) Assess the degree and nature of the distress associated with HSDD; (3) Determine the relationship between desire, arousal, and orgasm; (4) Assess the relationship between sexual desire and sexual activity, and; (5) Study the relationship between sexual desire and overall relationship and sexual satisfaction. DESIGN: The Women’s International Study of Health and Sexuality (WISHeS) was conducted by mail among US women, aged 20 –70 yrs. 85% of women who agreed to participate in the study completed and returned the survey. The survey included: (1) questions on women’s sexual activity and behavior, sexual and marital or relationship satisfaction, (2) the Profile of Female Sexual Function (PFSF), a validated instrument designed to assess sexual desire in women, and, (3) the Personal Distress Scale (PDS), a validated scale used to assess distress associated with low sexual desire in women. MATERIALS AND METHODS: The following populations of women (n⫽1235) were compared: (1) premenopausal (PreM) women (20 – 49 yrs) were compared to surgically menopausal (SM) women (20 – 49 yrs), and (2) surgically menopausal women (50 –70 yrs) were compared with naturally menopausal (NM) women (50 –70 yrs). Cut-off scores on the Desire Domain of the PFSF and the PDS were used, respectively, to classify women with low sexual desire and women with low desire who were distressed by it. RESULTS: About 1 in 4 PreM women and 1 in 3 SM or NM women were classified as having low sexual desire. Younger SM women were significantly more likely to be distressed about their low sexual desire and to be classified as having HSDD than PreM, older SM, or NM women. About 1 in 4 younger SM women, 1 in 6 PreM and older SM, and 1 in 10 NM women were classified as having HSDD. Women in all populations with low sexual desire were found to have co-morbid low sexual arousal. These women also initiated sexual activity, had intercourse, experienced orgasm and sexual pleasure significantly less often than women without low sexual desire. Low sexual desire was significantly correlated with decreased feelings of being sexually desirable (r⫽0.58) and lower satisfaction with sex life (r⫽0.49). Low satisfaction with sex life was significantly correlated with lower overall relationship satisfaction (r⫽0.56). CONCLUSION: HSDD is prevalent and distressing to many menopausal women. It is associated with reduced sexual and overall relationship satisfaction. The sexual experience and behavior of women with low sexual desire is different than women without low desire, i.e., they initiate sex less frequently, experience fewer orgasms and report diminished sexual pleasure. These results demonstrate that HSDD is a clinically relevant condition that warrants clinical attention. Supported by: Procter and Gamble Pharmaceuticals
Tuesday, October 19, 2004 3:00 P.M. O-195 Pilot study assessing the impact of hormonal contraceptives on serum testosterone levels and sexual function in pre-menopausal women. S. Sarajari, D. S. Wickman, C. M. Marin, J. R. Berman. UCLA Medical Center, Los Angeles, CA. OBJECTIVE: Approximately 15% of women receiving hormonal contraception (HC) experience sexual dysfunction (low libido and vaginal dryness). The goal of this study was to examine the relationship between changes in serum androgen profiles and specific sexual function complaints. DESIGN: This was a prospective questionnaire-based study. MATERIALS AND METHODS: Pre-menopausal women receiving HC (oral, vaginal or transdermal delivery) for at least 6 months discontinued medication at the end of their cycle and the date of last menstrual period was
Vol. 82, Suppl. 2, September 2004
demonstrate improved sexual function with testosterone treatment in naturally menopausal women. These findings are consistent with results from Phase III studies in surgically menopausal women. O-194
Hypoactive sexual desire disorder in menopausal women in the US. S. R. Leiblum, P. E. Koochaki, C. A. Rodenberg. UMDNJ-Robert Wood Johnson Medical School, Piscataway, NJ; Procter and Gamble Pharmaceuticals, Mason, OH.
Tuesday, October 19, 2004 2:30 P.M. O-193 The long-term effects of tibolone on libido in surgically postmenopausal women. L. Tutuncu, A. R. Ergur, E. Mungen, M. Muhcu, Y. Z. Yergok. GMMA, Haydarpasa Training Hospital, Istanbul, Turkey. OBJECTIVE: Many surgically postmenopausal women have decreased libido, sexual activity and pleasure. The effect of hormone therapy on sexual function is controversial. We conducted a study to determine the long-term efficacy of tibolone on sexual function in surgically postmenopausal women. DESIGN: Prospective, observational, open, clinical study. MATERIALS AND METHODS: We studied 116 healthy women, 41 to 55 years old (48.40 ⫾ 3.84) who received tibolone 2.5 mg/day (Livial™ Organon, Turkey) orally for 4 years (Treatment group). Another 94 women, 40 to 57 years old (49.06 ⫾ 4.52) who didn’t want to start any kind of hormone therapy received calcium 1000 mg/day (Control group). All study participants had been in a monogamous, heterosexual relationship for at least 5 years and undergone hysterectomy and bilateral salpingo-oophorectomy not more than 1 year ago. At baseline and after each year of treatment, patients were asked to complete a questionnaire consisting of the first 7 questions of McCoy’s Sex Scale Questionnaire. In this questionnaire each answer was given a value from 1 to 7. The scoring for each of the 7 questions was analyzed separately and then all the scores were added together to give a total score. Groups were compared to each other with this questionnaire at baseline and after 1, 2, 3 and 4 years. Statistical analyses were performed with using Wilcoxon test, Mann-Witney’s U test and student’s t-test. A P value of ⬍0.05 was considered statistically significant. RESULTS: Eighty five patients on treatment group and sixty patients on control group completed the study. Treatment and control group were comparable with regard to demographic characteristics and baseline sexual function parameters. Statistically significant improvement was seen after 1 year compared to baseline in each score obtained from seven questions assessing sexual function and total score of the questionnaire in the tibolone receiving group (p⬍0.05). This improvement was maintained until the end of 4 years. On the other hand none of the 7 parameters in control group had improved after 1 year and conversely bothersome sexual problems were persisted after 2, 3 and 4 years. When treatment group was compared to control group higher scores were found regarding all questions in favor of tibolone treatment at first year and these differences were still statistically significant after 4 years. Significant weight gain was observed after 1 year in the tibolone group compared with the control group and this significance persisted until the end of 4 years. The incidences of other adverse events were similar in both groups. CONCLUSION: The results suggest that tibolone 2.5 mg/day has beneficial long-term effects on libido and sexual life in women who have undergone hysterectomy and bilateral salpingo-oophorectomy. Tibolone can be a good long-term alternative for sexual problems in surgically postmenopausal women. Supported by: None.
S78
Abstracts
OBJECTIVE: (1) Determine the proportion of menopausal women with Hypoactive Sexual Desire Disorder (HSDD); (2) Assess the degree and nature of the distress associated with HSDD; (3) Determine the relationship between desire, arousal, and orgasm; (4) Assess the relationship between sexual desire and sexual activity, and; (5) Study the relationship between sexual desire and overall relationship and sexual satisfaction. DESIGN: The Women’s International Study of Health and Sexuality (WISHeS) was conducted by mail among US women, aged 20 –70 yrs. 85% of women who agreed to participate in the study completed and returned the survey. The survey included: (1) questions on women’s sexual activity and behavior, sexual and marital or relationship satisfaction, (2) the Profile of Female Sexual Function (PFSF), a validated instrument designed to assess sexual desire in women, and, (3) the Personal Distress Scale (PDS), a validated scale used to assess distress associated with low sexual desire in women. MATERIALS AND METHODS: The following populations of women (n⫽1235) were compared: (1) premenopausal (PreM) women (20 – 49 yrs) were compared to surgically menopausal (SM) women (20 – 49 yrs), and (2) surgically menopausal women (50 –70 yrs) were compared with naturally menopausal (NM) women (50 –70 yrs). Cut-off scores on the Desire Domain of the PFSF and the PDS were used, respectively, to classify women with low sexual desire and women with low desire who were distressed by it. RESULTS: About 1 in 4 PreM women and 1 in 3 SM or NM women were classified as having low sexual desire. Younger SM women were significantly more likely to be distressed about their low sexual desire and to be classified as having HSDD than PreM, older SM, or NM women. About 1 in 4 younger SM women, 1 in 6 PreM and older SM, and 1 in 10 NM women were classified as having HSDD. Women in all populations with low sexual desire were found to have co-morbid low sexual arousal. These women also initiated sexual activity, had intercourse, experienced orgasm and sexual pleasure significantly less often than women without low sexual desire. Low sexual desire was significantly correlated with decreased feelings of being sexually desirable (r⫽0.58) and lower satisfaction with sex life (r⫽0.49). Low satisfaction with sex life was significantly correlated with lower overall relationship satisfaction (r⫽0.56). CONCLUSION: HSDD is prevalent and distressing to many menopausal women. It is associated with reduced sexual and overall relationship satisfaction. The sexual experience and behavior of women with low sexual desire is different than women without low desire, i.e., they initiate sex less frequently, experience fewer orgasms and report diminished sexual pleasure. These results demonstrate that HSDD is a clinically relevant condition that warrants clinical attention. Supported by: Procter and Gamble Pharmaceuticals
Tuesday, October 19, 2004 3:00 P.M. O-195 Pilot study assessing the impact of hormonal contraceptives on serum testosterone levels and sexual function in pre-menopausal women. S. Sarajari, D. S. Wickman, C. M. Marin, J. R. Berman. UCLA Medical Center, Los Angeles, CA. OBJECTIVE: Approximately 15% of women receiving hormonal contraception (HC) experience sexual dysfunction (low libido and vaginal dryness). The goal of this study was to examine the relationship between changes in serum androgen profiles and specific sexual function complaints. DESIGN: This was a prospective questionnaire-based study. MATERIALS AND METHODS: Pre-menopausal women receiving HC (oral, vaginal or transdermal delivery) for at least 6 months discontinued medication at the end of their cycle and the date of last menstrual period was
Vol. 82, Suppl. 2, September 2004