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

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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.

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

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 ...

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Discussion​

We found that the 8 weeks of testosterone undecanoate 40 mg given twice weekly with daily estrogen was associated with a significant improvement in the women’s overall sexual function when compared with estrogen alone, especially for the arousal domain. The recorded adverse effects of low dose testosterone undecanoate administered for 8 weeks was comparable to the placebo group for acne and hirsutism. We did not observe any vaginal bleeding. There were no changes in hematocrit, liver enzymes or lipid profile after 8-weeks of treatment. However, it is possible that the sample size used in this study may not have been powered enough to detect differences between the two groups with respect to the safety variables.
Among couples, sexual intercourse is one of the most important factors that can significantly affect the status and health of the relationship. Female sexual dysfunction is the result of interplay of biological, psychological, physiological, status/health of the relationship and sociocultural factors. However, in postmenopausal women, hormonal factor is deemed to be an important factor influencing female sexual dysfunction. Estrogen has been shown to be associated with the woman’s sexual drive/desire and used widely to relieve menopausal symptoms, vaginal dryness, dyspareunia and to improve libido. On the contrary, the role of testosterone in postmenopausal hormone therapy is less clear. It is not as commonly prescribed as estrogen which may partly be due to the concern over side effect and long-term safety.
Previous studies have shown that low levels of testosterone were significantly associated with reduced sexual desire, arousal and responsiveness in women [2, 3]. Other studies showed that by adding testosterone to hormonal therapy it can improve sexual function in postmenopausal women [2–10]. These data indicate that supplemental testosterone may help increase sexual function in postmenopausal women but its short- and long-term safety remains to be of concern [19]. Our study was aimed to look into the short-term effects of adding testosterone undecanoate to estrogen for the improvement of female sexual dysfunction among postmenopausal women as well as its possible androgenic side effects when administered a low dose of 40 mg twice weekly.
Sexual function is difficult to assess because it is composed of a combination of biological and psychological factors/variables. Protocols to assess quality of sexual life varied from study to study and make it difficult to compare outcomes. In the present study, we used the FSFI questionnaire which has been validated for various aspects of sexual function and performance in pre and postmenopausal women on estrogen and testosterone. FSFI is a well-standardized questionnaire which objectively assesses the subjective outcome. We used the FSFI total score of 26.5 to be the optimal cutoff score because it has been demonstrated to differentiate women with and without sexual dysfunction [18].
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Conclusions​

This study appears to support the addition of the lower dose and twice weekly administration of testosterone undecanoate to daily estrogen for postmenopausal women with female sexual dysfunction, however, a larger study with a longer duration is needed to confirm the long-term efficacy and safety profiles. Besides the monitoring of vaginal bleeding, endometrial assessment should be properly evaluated to confirm the testosterone effect on endometrial safety. Partner’s influence should also be taken into account because it is known to have high influence over female’s sexuality.

 

[Nelson Vergel]

Interesting study from India. We do not have 40 mg capsules in the US.

I found these products in India:

List of substitutes for Testosterone Undecanoate 40 mg Capsule
Androfil 40 mg Capsule
Cipla Ltd.

Androsure 40 mg Capsule
Zydus Cadila

Testofil 40 mg Capsule
Zydus Cadila

 

[Dr.V.P.C.]

Nowadays there is a novel trend to use androgens in women this way (low frequency, oral route).
Works very well.