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Female sexual function improved with ospemifene in postmenopausal women with vulvar and vaginal atrophy: results of a randomized, placebo-controlled trial.

Constantine G, Graham S, Portman DJ, Rosen RC, Kingsberg SA - Climacteric (2014)

Bottom Line: Ospemifene 60 mg/day demonstrated a significantly greater FSFI total score improvement vs. placebo at Week 4 (p < 0.001).At Week 4, the FSFI domains of Sexual Pain, Arousal, and Desire were significantly improved with ospemifene vs. placebo; at Week 12, improvements in all domains were significant (p < 0.05).Changes in serum hormones were minor and uncorrelated with changes in sexual functioning.

View Article: PubMed Central - PubMed

Affiliation: EndoRheum Consultants , Media, PA.

ABSTRACT

Background: Ospemifene is a non-estrogen, tissue selective estrogen receptor agonist/antagonist, or selective estrogen receptor modulator, recently approved for the treatment of dyspareunia, a symptom of vulvar and vaginal atrophy (VVA), due to menopause. Postmenopausal dyspareunia is often associated with female sexual dysfunction (FSD). In this report, we present data that demonstrate the effect of ospemifene 60 mg/day on FSD assessed by the Female Sexual Function Index (FSFI), a widely used tool with six domains (Arousal, Desire, Orgasm, Lubrication, Satisfaction, and Pain).

Methods: A phase-3, randomized, double-blind, 12-week trial (n = 919) compared the efficacy and safety of oral ospemifene 60 mg/day vs. placebo in postmenopausal women with VVA in two strata based on self-reported, most bothersome symptom of either dyspareunia or dryness. Primary data were published previously. We report herein pre-specified secondary efficacy endpoints analyses, including changes from baseline to Weeks 4 and 12 for FSFI total and domain scores as well as serum hormone levels.

Results: Ospemifene 60 mg/day demonstrated a significantly greater FSFI total score improvement vs. placebo at Week 4 (p < 0.001). Improvement in FSFI scores continued to Week 12 (p < 0.001). At Week 4, the FSFI domains of Sexual Pain, Arousal, and Desire were significantly improved with ospemifene vs. placebo; at Week 12, improvements in all domains were significant (p < 0.05). Changes in serum hormones were minor and uncorrelated with changes in sexual functioning.

Conclusion: In a large, randomized, double-blind, placebo-controlled trial, ospemifene 60 mg/day significantly improved FSD in women with VVA. Consistent effects across FSFI domains were observed.

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Related in: MedlinePlus

Change from baseline to Weeks 4 and 12 (last observation caried forward) in the Female Sexual Function Index (FSFI) domain scores in the intent-to-treat (ITT) population. ∗, p < 0.05 compared with placebo; ∗∗, p < 0.001 compared with placebo. p Values were computed using ANCOVA where change from baseline was the response variable, baseline assessment was the covariate, and treatment and stratum were fixed effects. ANCOVA, analysis of covariance; LS, least squares; W4, Week 4; W12, Week 12
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Figure 3: Change from baseline to Weeks 4 and 12 (last observation caried forward) in the Female Sexual Function Index (FSFI) domain scores in the intent-to-treat (ITT) population. ∗, p < 0.05 compared with placebo; ∗∗, p < 0.001 compared with placebo. p Values were computed using ANCOVA where change from baseline was the response variable, baseline assessment was the covariate, and treatment and stratum were fixed effects. ANCOVA, analysis of covariance; LS, least squares; W4, Week 4; W12, Week 12

Mentions: In the ITT population, greater improvements were observed in all six FSFI domains in women treated with ospemifene 60 mg/day compared with placebo (Figure 3). At Week 4, statistically significant improvements were noted for the FSFI domains of Desire, Arousal, and Pain (all p < 0.05) and Lubrication (p < 0.001). The domain improvements noted in women treated with ospemifene continued to increase in magnitude and reached statistical significance in all domains compared with placebo by Week 12 (LOCF).


Female sexual function improved with ospemifene in postmenopausal women with vulvar and vaginal atrophy: results of a randomized, placebo-controlled trial.

Constantine G, Graham S, Portman DJ, Rosen RC, Kingsberg SA - Climacteric (2014)

Change from baseline to Weeks 4 and 12 (last observation caried forward) in the Female Sexual Function Index (FSFI) domain scores in the intent-to-treat (ITT) population. ∗, p < 0.05 compared with placebo; ∗∗, p < 0.001 compared with placebo. p Values were computed using ANCOVA where change from baseline was the response variable, baseline assessment was the covariate, and treatment and stratum were fixed effects. ANCOVA, analysis of covariance; LS, least squares; W4, Week 4; W12, Week 12
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4389697&req=5

Figure 3: Change from baseline to Weeks 4 and 12 (last observation caried forward) in the Female Sexual Function Index (FSFI) domain scores in the intent-to-treat (ITT) population. ∗, p < 0.05 compared with placebo; ∗∗, p < 0.001 compared with placebo. p Values were computed using ANCOVA where change from baseline was the response variable, baseline assessment was the covariate, and treatment and stratum were fixed effects. ANCOVA, analysis of covariance; LS, least squares; W4, Week 4; W12, Week 12
Mentions: In the ITT population, greater improvements were observed in all six FSFI domains in women treated with ospemifene 60 mg/day compared with placebo (Figure 3). At Week 4, statistically significant improvements were noted for the FSFI domains of Desire, Arousal, and Pain (all p < 0.05) and Lubrication (p < 0.001). The domain improvements noted in women treated with ospemifene continued to increase in magnitude and reached statistical significance in all domains compared with placebo by Week 12 (LOCF).

Bottom Line: Ospemifene 60 mg/day demonstrated a significantly greater FSFI total score improvement vs. placebo at Week 4 (p < 0.001).At Week 4, the FSFI domains of Sexual Pain, Arousal, and Desire were significantly improved with ospemifene vs. placebo; at Week 12, improvements in all domains were significant (p < 0.05).Changes in serum hormones were minor and uncorrelated with changes in sexual functioning.

View Article: PubMed Central - PubMed

Affiliation: EndoRheum Consultants , Media, PA.

ABSTRACT

Background: Ospemifene is a non-estrogen, tissue selective estrogen receptor agonist/antagonist, or selective estrogen receptor modulator, recently approved for the treatment of dyspareunia, a symptom of vulvar and vaginal atrophy (VVA), due to menopause. Postmenopausal dyspareunia is often associated with female sexual dysfunction (FSD). In this report, we present data that demonstrate the effect of ospemifene 60 mg/day on FSD assessed by the Female Sexual Function Index (FSFI), a widely used tool with six domains (Arousal, Desire, Orgasm, Lubrication, Satisfaction, and Pain).

Methods: A phase-3, randomized, double-blind, 12-week trial (n = 919) compared the efficacy and safety of oral ospemifene 60 mg/day vs. placebo in postmenopausal women with VVA in two strata based on self-reported, most bothersome symptom of either dyspareunia or dryness. Primary data were published previously. We report herein pre-specified secondary efficacy endpoints analyses, including changes from baseline to Weeks 4 and 12 for FSFI total and domain scores as well as serum hormone levels.

Results: Ospemifene 60 mg/day demonstrated a significantly greater FSFI total score improvement vs. placebo at Week 4 (p < 0.001). Improvement in FSFI scores continued to Week 12 (p < 0.001). At Week 4, the FSFI domains of Sexual Pain, Arousal, and Desire were significantly improved with ospemifene vs. placebo; at Week 12, improvements in all domains were significant (p < 0.05). Changes in serum hormones were minor and uncorrelated with changes in sexual functioning.

Conclusion: In a large, randomized, double-blind, placebo-controlled trial, ospemifene 60 mg/day significantly improved FSD in women with VVA. Consistent effects across FSFI domains were observed.

Show MeSH
Related in: MedlinePlus