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Improved bleeding profile and tolerability of tibolone versus transdermal E2/NETA treatment in postmenopausal women with female sexual dysfunction.
Climacteric. 2009 Apr; 12(2):114-21.C

Abstract

OBJECTIVES

To compare the incidence of vaginal spotting/bleeding events and breast pain between therapy with tibolone 2.5 mg and continuous combined transdermal estradiol (E(2))/norethisterone acetate (NETA) 50 microg/140 microg after 24 weeks of treatment.

METHODS

A double-blind, double-dummy, randomized, controlled trial was performed and assessments were performed at baseline, week 12 and week 24. Bleeding/spotting events were recorded in a daily diary. Breast signs and symptoms were collected as adverse events.

RESULTS

A total of 403 women (mean age 56 years) were randomized. Bleeding/spotting events during weeks 1-12 with tibolone and E(2)/NETA were experienced by 16% and 56% of women, respectively (p < 0.001). The corresponding percentages during weeks 13-24 were 12% and 51%, respectively (p < 0.001). E(2)/NETA was significantly more likely than tibolone to be associated with vaginal hemorrhage (11% vs. 0%; p < 0.001) and breast signs and symptoms (11% vs. 4%; p = 0.015). Early discontinuations resulting from adverse events were significantly more common in the E(2)/NETA group than in the tibolone group (20% vs. 12%), primarily related to withdrawal due to vaginal hemorrhage (8% vs. 0%).

CONCLUSIONS

Tibolone has a significantly better tolerability profile than transdermal E(2)/NETA as measured by vaginal bleeding, breast pain and treatment continuation.

Authors+Show Affiliations

Department of Obstetrics & Gynecology, Groningen University Medical Center, Groningen, The Netherlands.No 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 availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

19177255

Citation

Nijland, E A., et al. "Improved Bleeding Profile and Tolerability of Tibolone Versus Transdermal E2/NETA Treatment in Postmenopausal Women With Female Sexual Dysfunction." Climacteric : the Journal of the International Menopause Society, vol. 12, no. 2, 2009, pp. 114-21.
Nijland EA, Nathorst-Böös J, Palacios S, et al. Improved bleeding profile and tolerability of tibolone versus transdermal E2/NETA treatment in postmenopausal women with female sexual dysfunction. Climacteric. 2009;12(2):114-21.
Nijland, E. A., Nathorst-Böös, J., Palacios, S., van de Weijer, P. W., Davis, S., Stathopoulos, V. M., Birkhaeuser, M. H., von Mauw, E., Mulder, R. J., & Schultz, W. C. (2009). Improved bleeding profile and tolerability of tibolone versus transdermal E2/NETA treatment in postmenopausal women with female sexual dysfunction. Climacteric : the Journal of the International Menopause Society, 12(2), 114-21. https://doi.org/10.1080/13697130802576666
Nijland EA, et al. Improved Bleeding Profile and Tolerability of Tibolone Versus Transdermal E2/NETA Treatment in Postmenopausal Women With Female Sexual Dysfunction. Climacteric. 2009;12(2):114-21. PubMed PMID: 19177255.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Improved bleeding profile and tolerability of tibolone versus transdermal E2/NETA treatment in postmenopausal women with female sexual dysfunction. AU - Nijland,E A, AU - Nathorst-Böös,J, AU - Palacios,S, AU - van de Weijer,P W, AU - Davis,S, AU - Stathopoulos,V M, AU - Birkhaeuser,M H, AU - von Mauw,E, AU - Mulder,R J, AU - Schultz,W C M Weijmar, AU - ,, PY - 2009/1/30/entrez PY - 2009/1/30/pubmed PY - 2009/6/6/medline SP - 114 EP - 21 JF - Climacteric : the journal of the International Menopause Society JO - Climacteric VL - 12 IS - 2 N2 - OBJECTIVES: To compare the incidence of vaginal spotting/bleeding events and breast pain between therapy with tibolone 2.5 mg and continuous combined transdermal estradiol (E(2))/norethisterone acetate (NETA) 50 microg/140 microg after 24 weeks of treatment. METHODS: A double-blind, double-dummy, randomized, controlled trial was performed and assessments were performed at baseline, week 12 and week 24. Bleeding/spotting events were recorded in a daily diary. Breast signs and symptoms were collected as adverse events. RESULTS: A total of 403 women (mean age 56 years) were randomized. Bleeding/spotting events during weeks 1-12 with tibolone and E(2)/NETA were experienced by 16% and 56% of women, respectively (p < 0.001). The corresponding percentages during weeks 13-24 were 12% and 51%, respectively (p < 0.001). E(2)/NETA was significantly more likely than tibolone to be associated with vaginal hemorrhage (11% vs. 0%; p < 0.001) and breast signs and symptoms (11% vs. 4%; p = 0.015). Early discontinuations resulting from adverse events were significantly more common in the E(2)/NETA group than in the tibolone group (20% vs. 12%), primarily related to withdrawal due to vaginal hemorrhage (8% vs. 0%). CONCLUSIONS: Tibolone has a significantly better tolerability profile than transdermal E(2)/NETA as measured by vaginal bleeding, breast pain and treatment continuation. SN - 1473-0804 UR - https://www.unboundmedicine.com/medline/citation/19177255/Improved_bleeding_profile_and_tolerability_of_tibolone_versus_transdermal_E2/NETA_treatment_in_postmenopausal_women_with_female_sexual_dysfunction_ L2 - https://www.tandfonline.com/doi/full/10.1080/13697130802576666 DB - PRIME DP - Unbound Medicine ER -