Tibolone In Women Research Articles

PNM-35 Effects of Tribulus Terrestris and Tibolone on Sexuality in Post-Menopausal Women

Assessment of the effects of Tribulus terrestris and Tibolone in women with hypoactive sexual desire dysfunction after menopause.

Assessment of the effects of Tribulus terrestris and Tibolone on sexuality in post-menopausal women

Objective: Assessment of the effects of Tribulus terrestris and Tibolone in women with hypoactive sexual desire dysfunction after menopause.

Effects of tibolone on climacteric symptoms and quality of life in breast cancer patients—Data from LIBERATE trial

BackgroundClimacteric symptoms such as hot flushes and vaginal dryness are very common in breast cancer patients, resulting either from age or adjuvant therapy. Tibolone, a synthetic steroid, is effective in reducing these symptoms in healthy post-menopausal women, but this has never been studied in a large breast cancer population. ObjectivesThe primary objective of LIBERATE trial was to study safety of tibolone 2.5mg daily versus placebo as primary, in symptomatic breast cancer survivors. The aim of this present paper was to report effects of tibolone on climacteric symptoms, vaginal dryness and health-related quality of life in the study population. This trial is registered with ClinicalTrials.gov, n. NCT00408863. MethodsThe trial was conducted between June 2002 and July 2007. Concerning quality of life variables, a daily Diary Cards during the first three months and the Climacteric Symptoms Form and at each visit were used to register frequency and intensity of hot flushes. Mean vaginal dryness scores were calculated on the basis of individual ratings at baseline and at week 104. A subset of patients assessed their quality of life filling in the Women's Health Questionnaire (WHQ). ResultsOf the 3148 women recruited, 3133 received trial medication (1575 in the tibolone group and 1558 in the placebo group). The median duration of treatment was 2.75 years. In total 3098 women (1556 on tibolone, 1542 on placebo) were included in the intention-to-treat (ITT) population for efficacy analysis. Data on vaginal dryness are available for 2144 patients and 883 women (438 on tibolone, 445 on placebo) answered to WHQ. The mean change in number of hot flushes per day was 2.74 (43.1%) in the tibolone group and −1.77 (−27.5%) in the placebo group (p<0.0001) at week 12 and −4.62 (−65.6%) on tibolone as compared to −3.73 (−52.5%) on placebo (p<0.0001) at week 104. For the composite score the mean changes at week 12 were −0.19 (−10.6%) and −0.14 (−7.7%), respectively (p=0.0006). Vaginal dryness score improved at week 104 in the tibolone group as compared to placebo (−0.46 versus −0.29, respectively; p<0.0001). Across the assessments up to two years with WHQ, tibolone was more effective than placebo in improving sexual health, sleep quality and mood domains. Women using tamoxifen showed less improvement in climacteric symptoms with tibolone, than women only receiving tibolone without any adjuvant therapy. ConclusionThe results of the LIBERATE trial show that tibolone is effective in symptomatic breast cancer patients and improves their quality of life. However, this finding should be judged within the context of the main outcome of the trial, showing that tibolone increases the risk of recurrence. The use of tibolone in women with breast cancer will remain contraindicated and any off-label use incurs a now proven risk.

Leuprolide acetate treatment with and without coadministration of tibolone in premenopausal women with menstrual cycle–related irritable bowel syndrome

To evaluate the effectiveness of gonadotropin-releasing hormone agonists (GnRH-a) with or without coadministration of tibolone in women with menstrual cycle-related irritable bowel syndrome (IBS). Prospective, randomized, placebo-controlled clinical trial. Universities of Catanzaro and Naples. One hundred twenty young premenopausal women with menstrual cycle-related IBS (Rome II criteria). Administration of leuprolide acetate depot (LAD, 11.25 mg IM/3 months) plus tibolone (group A), LAD plus placebo tablets (group B), and injection of a placebo solution plus placebo tablets (group C). Severity of bowel symptoms or signs of IBS and quality of life (QoL), at baseline and after 6 months of treatment. In all groups, the mean scores for each symptom or sign of IBS and for QoL were significantly improved after treatment. A significant difference was observed between group C and groups A and B. No difference between these last groups was detected in symptoms or signs of IBS. The QoL scores were significantly higher in group A than in group B. Gondotropin-releasing hormone agonist administration is effective in women with menstrual cycle-related IBS. The addition of tibolone does not reduce effectiveness compared with agonist alone and increases QoL.

A pilot study of hormone replacement therapy with tibolone in women with mastopathic breasts

Objective: Our purpose was to investigate the effect of tibolone in a prospective randomized, double-blind pilot study in postmenopausal women with clinically palpable mastopathic changes. Methods: Twenty postmenopausal non-users of hormone replacement therapy undergoing mammography were randomly allocated to receive either 2.5 mg tibolone (Livial®, Organon) or placebo (2 mg lactose). Mammographic density according to the Wolfe classification, severity of breast discomfort, parity, smoking habits, body weight and follicle-stimulating hormone (FSH) and estradiol (E 2) levels were documented at baseline and after 6 months of treatment. Results: There were no statistically significant differences between the two treatment groups in terms of parity, smoking, body weight and FSH and E 2 levels. At 6 months, four patients in the tibolone group showed reduced breast density, compared with one patient in the placebo group. Whereas no significant differences were found between the two treatment groups when the categories ‘minimal reduction’ and ‘reduction’ in mammographic density were combined, combination of the categories ‘no change’ and ‘minimal reduction’ showed a significant difference ( P<0.036). Also, women in the tibolone group showed a statistically significant improvement in breast discomfort ( P<0.019). Conclusion: This pilot study showed decreases in breast density as well as an attendant significant alleviation of breast discomfort in women with baseline mastopathic changes treated with tibolone for 6 months, which may be due to the inhibitory effect of tibolone on the enzymes involved in the biosynthesis of estradiol demonstrated in previous trials and should be further evaluated in long-term studies.

The Use of Add-Back Tibolone in Women Treated with Goserelin for Severe PMS

The Use of Add-Back Tibolone in Women Treated with Goserelin for Severe PMS

Effectiveness and long-term safety of prolonged gosereline and tibolone in women with endometriosis

Gonadotropin-releasing hormone (GnRH) agonists are widely administered to treat endometriosis, but generally are not prescribed for more than 6 months since they are associated with vasomotor symptoms and bone loss. A GnRH agonist and steroid add-back therapy can be given for longer times without flare-up or significant hypoestrogenic symptoms. We examined the efficacy and safety of a weak estrogenic steroid, OD14, with prolonged goserelin treatment in seven regularly menstruating women (age 26-33 yrs) with laparoscopically diagnosed, symptomatic endometriosis. The women received goserelin 3.65 mg subcutaneously/month and 2.5 mg OD14 2.5 mg/day beginning in the fourth cycle for 18 to 20 months. The frequency and severity of hot flushes, sweating, irritability, loss of libido, nervousness, and sleeplessness were scored by the women on a scale of 0 to 6 and compared. Samples of blood and urine were obtained to measure serum estradiol (E2) levels, lipids, and urinary calcium:creatinine (Ca:Cr) ratios at the start of treatment and monthly thereafter. The vasomotor scores, serum E2 levels, and urine Ca:Cr ratios were consistent with the hypoestrogenism induced by goserelin (24.2 &plusmn; 3.1, 18.5 &plusmn; 7.2 pg/ml, and 0.063 &plusmn; 0.008, respectively). The decreases in vasomotor scoring with regard to hot flushing, sweating, and urinary Ca:Cr ratios were significant after adding OD14 (14.8 &plusmn; 2.2, 0.031 &plusmn; 0.005, p <0.05), whereas E2 levels remained below 40 pg/ml (23.1 &plusmn; 8.2 pg/ml, p >0.05) throughout therapy. The increased low-density:high-density lipoprotein ratio with goserelin improved with OD14, remaining at the lower limit of normal. Thus, OD14 add-back to GnRH agonist therapy enabled us to extend medical therapy of endometriosis longer than 6 months, preventing hypoestrogenic side effects, and with adequate suppression endometriosis symptoms.