Tibolone and transdermal E2/NETA for the treatment of female sexual dysfunction in naturally menopausal women: results of a randomized active-controlled trial.

INTRODUCTION: There are some data to suggest that tibolone improves sexual function in postmenopausal women. However, evidence about the effects of tibolone on female sexual dysfunction is lacking. AIM: To compare the efficacy on sexual function of tibolone 2.5 mg to continuous combined transdermal estradiol (E2)/norethisterone acetate (NETA) (50 microg/140 microg) in naturally postmenopausal women with sexual dysfunction. MAIN OUTCOME MEASURE: Differences between treatment groups in the change from baseline for the composite subscore of the arousal, desire, and satisfaction domains of the self-reported Female Sexual Function Index (FSFI). METHODS: A multicenter, double-blind, randomized, clinical trial was performed. Sexual function was assessed with the FSFI at baseline, week 12, and week 24. The outcomes of the Female Sexual Distress Scale (FSDS) and the frequency of satisfying sexual events (daily diaries) were secondary end points. RESULTS: Four hundred three women, mean age 56, were included. Both therapies improved sexual function assessed by the FSFI. In the per protocol analysis, but not in the intent-to-treat analysis, the increase in FSFI scores was significantly larger in the tibolone group when compared with the E2/NETA patch group at week 24 (P = 0.036 and P = 0.025 for the composite subscore and total FSFI score, respectively). The satisfying sexual event rate increased from three to four times per 28 days at week 24 (P < 0.001 from baseline for both groups), with no difference between groups. The FSDS showed a significant decrease from baseline (P < 0.001), which was comparable for both treatment groups. CONCLUSIONS: Both treatments resulted to improved overall sexual function, as determined by scores on the FSFI, an increase in the frequency of sexual events, and a reduction in sexuality-related personal distress. The statistically significant higher FSFI scores in the tibolone group, when compared to the E2/NETA group, may be because of tibolone's combined estrogenic and androgenic properties.

Percutaneous administration of testosterone gel in postmenopausal women--a pharmacological study.

We wished to investigate if a testosterone gel administered percutaneously to postmenopausal women could result in stable serum levels of the hormone and which dose was required to produce levels within the normal premenopausal range. Fifteen postmenopausal women, mean age 55.3 years (range 45-70 years), volunteered to participate in the study and were divided into three groups. They received 10, 20 or 30 mg of testosterone as a 1% testosterone hydroalcoholic gel at 09.00 hours daily for 14 days. The gel was applied in a thin layer on the outside of the thigh each morning, over an area of approximately 15 cm(2). Blood samples were collected hourly between 09.00 and 17.00 hours on days 1 and 14, and also at 08.00 hours on days 3, 5, 11, 12, 13 and finally day 16, i.e. 2 days after termination of treatment. The mean basal serum level of testosterone was 1.1 +/- 0.9 nmol/l and for 5a-dihydrotestosterone 208 +/- 143 pmol/l. There was a clear increase from the 10 mg to the 20 mg treatment (mean testosterone level during treatment 3.2 and 7.2 nmol/l, respectively) while serum testosterone values after 30 mg showed very little further increase (mean 7.5 nmol/l). Values for days 3-5 were quite similar to those for days 13-14. The present study suggests that adequate and acceptable serum levels of testosterone can be achieved with 10 mg testosterone applied transdermally.

Risk factors for persistent trophoblastic activity after surgery for ectopic pregnancy.

BACKGROUND: The purpose of this study was to explore the value of preoperative ultrasound and human chorionic gonadotropin (hCG) monitoring to predict the occurrence of residual trophoblastic tissue after laparoscopic conservative surgery for tubal pregnancy. METHODS: During the period from January 1998 to December 1999 all 206 women undergoing treatment for ectopic pregnancy at the Karolinska hospital were included in the study. A vaginal ultrasound examination was performed and the ectopic size was measured. Serum-hCG levels were recorded preoperatively, and at days 1-2 and 14-21 after surgery. RESULTS: A diameter of 8 mm or less was observed in 13 of the 14 patients needing secondary treatment. The risk of second surgery if the finding at the preoperative ultrasound was larger than 8 mm was 1/73 resulting in a negative predictive value of 0.01. A considerable overlap in the hCG levels was found on days 1-2 after surgery between women with and without second surgery. CONCLUSIONS: Using a single cutoff point for hCG seems to be of little value as residual trophoblastic tissue can manifest itself at different times--early or late--during the postoperative period. Women with a small ectopic pregnancy as detected by preoperative vaginal ultrasound are at high risk of developing residual trophoblastic tissue. These patients should be considered by the surgeon and monitored with hCG levels until values decline and become undetectable. Management of patients with slowly but declining values can be conservative. If hCG levels are rising or do not decline, methotrexate (MTX) can be an alternative.