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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

Mean ± standard deviation serum hormone concentrations at baseline and Week 12 in the intent-to-treat population. BL, baseline; FSH, follicle stimulating hormone; LH, luteinizing hormone; SHBG, sex hormone binding globulin; W12, Week 12
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Figure 5: Mean ± standard deviation serum hormone concentrations at baseline and Week 12 in the intent-to-treat population. BL, baseline; FSH, follicle stimulating hormone; LH, luteinizing hormone; SHBG, sex hormone binding globulin; W12, Week 12

Mentions: For the women in the ospemifene group, both mean FSH and LH levels decreased slightly from baseline to Week 12 while remaining well within the normal range for postmenopausal women. There were no clinically relevant changes in mean estradiol levels after treatment with ospemifene. The mean SHBG level increased, but remained within the normal range at Week 12 (20–130 nmol/l). One ospemifene participant in the dryness stratum and 25 participants (24 ospemifene, one placebo) in the dyspareunia stratum shifted from normal SHBG levels at baseline to higher than normal levels at Week 12. Total testosterone levels increased slightly in women in the ospemifene group; however, mean free testosterone levels remained unchanged (Figure 5).


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)

Mean ± standard deviation serum hormone concentrations at baseline and Week 12 in the intent-to-treat population. BL, baseline; FSH, follicle stimulating hormone; LH, luteinizing hormone; SHBG, sex hormone binding globulin; W12, Week 12
© Copyright Policy - open-access
Related In: Results  -  Collection

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

Figure 5: Mean ± standard deviation serum hormone concentrations at baseline and Week 12 in the intent-to-treat population. BL, baseline; FSH, follicle stimulating hormone; LH, luteinizing hormone; SHBG, sex hormone binding globulin; W12, Week 12
Mentions: For the women in the ospemifene group, both mean FSH and LH levels decreased slightly from baseline to Week 12 while remaining well within the normal range for postmenopausal women. There were no clinically relevant changes in mean estradiol levels after treatment with ospemifene. The mean SHBG level increased, but remained within the normal range at Week 12 (20–130 nmol/l). One ospemifene participant in the dryness stratum and 25 participants (24 ospemifene, one placebo) in the dyspareunia stratum shifted from normal SHBG levels at baseline to higher than normal levels at Week 12. Total testosterone levels increased slightly in women in the ospemifene group; however, mean free testosterone levels remained unchanged (Figure 5).

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