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Tibolone and transdermal E2/NETA for the treatment of female sexual dysfunction in naturally menopausal women: results of a randomized active-controlled trial.
J Sex Med. 2008 Mar; 5(3):646-56.JS

Abstract

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.

Authors+Show Affiliations

University Medical Center Groningen, Department of Psychosomatic Obstetrics and Gynaecology, Groningen, The Netherlands. e.nijland2@kpnplanet.nlNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Controlled Clinical Trial
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

18304284

Citation

Nijland, Esme A., et al. "Tibolone and Transdermal E2/NETA for the Treatment of Female Sexual Dysfunction in Naturally Menopausal Women: Results of a Randomized Active-controlled Trial." The Journal of Sexual Medicine, vol. 5, no. 3, 2008, pp. 646-56.
Nijland EA, Weijmar Schultz WC, Nathorst-Boös J, et al. Tibolone and transdermal E2/NETA for the treatment of female sexual dysfunction in naturally menopausal women: results of a randomized active-controlled trial. J Sex Med. 2008;5(3):646-56.
Nijland, E. A., Weijmar Schultz, W. C., Nathorst-Boös, J., Helmond, F. A., Van Lunsen, R. H., Palacios, S., Norman, R. J., Mulder, R. J., & Davis, S. R. (2008). Tibolone and transdermal E2/NETA for the treatment of female sexual dysfunction in naturally menopausal women: results of a randomized active-controlled trial. The Journal of Sexual Medicine, 5(3), 646-56. https://doi.org/10.1111/j.1743-6109.2007.00726.x
Nijland EA, et al. Tibolone and Transdermal E2/NETA for the Treatment of Female Sexual Dysfunction in Naturally Menopausal Women: Results of a Randomized Active-controlled Trial. J Sex Med. 2008;5(3):646-56. PubMed PMID: 18304284.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Tibolone and transdermal E2/NETA for the treatment of female sexual dysfunction in naturally menopausal women: results of a randomized active-controlled trial. AU - Nijland,Esme A, AU - Weijmar Schultz,Willibrord C M, AU - Nathorst-Boös,Jörgen, AU - Helmond,Frans A, AU - Van Lunsen,Rik H W, AU - Palacios,Santiago, AU - Norman,Robert J, AU - Mulder,Roel J, AU - Davis,Susan R, AU - ,, PY - 2008/2/29/pubmed PY - 2008/4/11/medline PY - 2008/2/29/entrez SP - 646 EP - 56 JF - The journal of sexual medicine JO - J Sex Med VL - 5 IS - 3 N2 - 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. SN - 1743-6109 UR - https://www.unboundmedicine.com/medline/citation/18304284/Tibolone_and_transdermal_E2/NETA_for_the_treatment_of_female_sexual_dysfunction_in_naturally_menopausal_women:_results_of_a_randomized_active_controlled_trial_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1743-6095(15)31954-8 DB - PRIME DP - Unbound Medicine ER -