Effectiveness of a low dose testosterone undecanoate to improve sexual function in postmenopausal women

Reuthairat Tungmunsakulchai, Sukanya Chaikittisilpa, Thiti Snabboon, Krasean Panyakhamlerd, Unnop Jaisamrarn, Nimit Taechakraichana, Reuthairat Tungmunsakulchai, Sukanya Chaikittisilpa, Thiti Snabboon, Krasean Panyakhamlerd, Unnop Jaisamrarn, Nimit Taechakraichana

Abstract

Background: Adding testosterone to hormonal therapy could improve sexual function and general well-being among women during climacteric. We evaluated the effectiveness of testosterone undecanoate on sexual function in postmenopausal women utilizing the standardized questionnaire FSFI score.

Methods: Postmenopausal women with sexual complaints and Female Sexual Function Index (FSFI) ≤ 26.5 were enrolled in to this randomized, double-blinded, placebo-controlled trial. Participants were randomly assigned to 8-week treatment with either oral testosterone undecanoate 40 mg or placebo twice weekly with daily oral estrogen. The FSFI scores before and after treatment were compared to assess any improvement of sexual function.

Results: Seventy women were recruited of which each group had 35 participants. The baseline characteristics and baseline FSFI scores were comparable between both groups. After 8 weeks of treatment, the FSFI scores significantly improved in both groups when compared to the baseline but the FSFI scores from the testosterone group were significantly higher than in the placebo group post-treatment (28.6 ± 3.6, 25.3 ± 6.7, respectively, p = 0.04). There was no difference in adverse effect between the two groups

Conclusions: The twice weekly addition of testosterone undecanoate to daily oral estrogen was associated with a significant improvement in sexual function among postmenopausal women than the use of the estrogen alone.

Trial registration: ClinicalTrials.gov Identifier NCT01724658 (February 17, 2012).

Figures

Fig. 1
Fig. 1
Flow diagram of study, based on CONSORT guidelines 2010

References

    1. Peeyananjarassri K, Liabsuetrakul T, Soonthornpun K, Choobun T, Manopsilp P. Sexual functioning in postmenopausal women not taking hormone therapy in the Gynecological and Menopause Clinic, Songklanagarind Hospital measured by female sexual function index questionaire. J Med Assoc Thai. 2008;91:625–32.
    1. Schwenkhagen A, Studd J. Role of testosterone in the treatment of hypoactive sexual desire disorder. Maturitas. 2009;63:152–9. doi: 10.1016/j.maturitas.2009.02.011.
    1. Anita HC. The pathophysiology of hypoactive sexual desire disorder in women. Inter J Gynecol Obstet. 2010;110:7–11. doi: 10.1016/j.ijgo.2010.02.014.
    1. Shifren JL, Glenn DB, James AS, Peter RC, John EB, Geoffrey PR, et al. Transdermal testosterone treatment in women with impaired sexual function after oophorectomy. N Engl J Med. 2000;343:682–8. doi: 10.1056/NEJM200009073431002.
    1. The North American Menopause Society . The Role of Testosterone Therapy in Postmenopausal Women: Position Statement of The North American Menopause Society. USA: The North American Menopause Society; 2005.
    1. Shifren JL, Davis SR, Moreau M, Waldbaum A, Bouchard C, DeRogatis L, et al. Testosterone patch for the treatment of hypoactive sexual desire disorder in naturally menopausal women: results from the INTIMATE NM1 Study. Menopause. 2006;13:770–8. doi: 10.1097/01.gme.0000227400.60816.52.
    1. Somboonporn W, Bell RJ, Davis SR. Androgen and menopause. Curr Opin Obstet Gynecol. 2006;18:427–32. doi: 10.1097/01.gco.0000233938.36554.37.
    1. Kingsberg S, Shifren JL, Wekselman K, Rodenberg C, Koochaki P, DeRogatis L. Evaluation of the clinical relevance of benefits associated with transdermal testosterone in postmenopausal women with hypoactive sexual desire disorder. J Sex Med. 2007;4:1001–8. doi: 10.1111/j.1743-6109.2007.00526.x.
    1. Somboonporn W, Bell JR, Davis RS, Seif MW, Bell R. Testosterone for peri and postmenopausal women. Cochrane Database Syst Rev. 2005;19(4):CD004509.
    1. Alvaro M, Brenda J, Jeremy PW, Mark L. Testosterone supplementation for hypogonadal impotence: Assessment of biochemical measures and therapeutic outcomes. J Urol. 1997;157:849–854. doi: 10.1016/S0022-5347(01)65062-6.
    1. Köhn FM, Schill WB. A new oral testosterone undecanoate formulation. World J Urol. 2003;21:311–5. doi: 10.1007/s00345-003-0372-x.
    1. Flöter A, Carlström K, Schoultz B, Nathorst-Böös J. Administration of testosterone undecanoate in postmenopausal women: effects on androgens, estradiol, and gonadotrophins. Menopause. 2000;7:251–6. doi: 10.1097/00042192-200007040-00007.
    1. Flöter A, Nathorst-Böös J, Carlström K, Schoultz B. Addition of testosterone to estrogen replacement therapy in oophorectomized women: effects on sexuality and well-being. Climacteric. 2002;5:357–65. doi: 10.1080/cmt.5.4.357.365.
    1. Miller K, Biller K, Beauregard C, Lipman G, Jones J, Schoenfeld D, et al. Effects of testosterone replacement in androgen deficient women with hypopituitarism: a randomized, double-blind, placebo-controlled study. J Clin Endocrino Metab. 2006;5:1683–90. doi: 10.1210/jc.2005-2596.
    1. Rosen R, Brown C, Heiman J, Leiblum S, Meston C, Shabsigh R, et al. The female sexual function index (FSFI): a multidimensional self-report instrument for the assessment of female sexual function. J Sex Marital Ther. 2000;26:191–208. doi: 10.1080/009262300278597.
    1. Meston CM. Validation of the female sexual function index (FSFI) in women with female orgasmic disorder and in women with hypoactive sexual desire disorder. J Sex Marital Ther. 2003;29:39–46. doi: 10.1080/713847100.
    1. Meston CM, Derogatis LR. Validated instruments for assessing female sexual function. J Sex Marital Ther. 2002;28:155–64. doi: 10.1080/00926230252851276.
    1. Wiegel M, Meston CM, Rosen R. The female sexual function index (FSFI): cross-validation and development of clinical cutoff scores. J Sex Marital Ther. 2005;31:1–20. doi: 10.1080/00926230590475206.
    1. Hong Z, Lena S, Britt M, Elina E, Angelica L. Effects of testosterone treatment on endometrial proliferation in postmenopausal women. J Clin Endocrino Metab. 2006;9:3697–710.

Source: PubMed

Sponsoren und Mitarbeiter

Krankheiten

Drogeninterventionen

3
Abonnieren