Study design : Three 12-week, randomized, double-blind, placebo-controlled, parallel group studies in post meopausal women. 1,2
Statistically significant results seen with Osphena®:1
- Increase in the proportion of superficial cells (p<0.0001)
- Decrease in the proportion of parabasal cells (p<0.0001)
- Reduction in vaginal pH (p<0.0001)
Graphic representation of study results at Week 12*
*For illustration purposes only. Individual results may vary.
LS mean change from baseline to Week 12 in percentage of superficial and parabasal cells in vaginal smears (mITT populations; MMRM analysis)2
| % Superficial cells | % Parabasal cells | |||
|---|---|---|---|---|
| Study 12 | Placebo | N=90 | 1.6 | -2.3 |
| Ospemifene 60 mg | N=109 | 11.6 | -27.4 | |
| Study 22 | Placebo | N=146 | 3.6 | -4.2 |
| Ospemifene 60 mg | N=148 | 13.3 | -34.6 | |
| Study 32 | Placebo | N=241 | 1.8 | -3.4 |
| Ospemifene 60 mg | N=247 | 9.5 | -27.4 |
LS: least squares; mITT: modified intent-to-treat; MMRM: Mixed-effects Model Repeated Measure
Studies 2 and 3: dryness strata data (comparable changes observed with dyspareunia strata)
Osphena® significantly improved vaginal pH in 12 weeks or less1,2,3
Osphena® significantly decreased vaginal pH by Week 12 in three clinical trials.*,†,1,2
LS mean change from baseline to Week 12 in vaginal pH (mITT populations; MMRM analysis)2
LS: least squares; mITT: modified intent-to-treat; MMRM: Mixed-effects Model Repeated Measure
Women in both treatment groups were instructed to use vaginal lubricant as needed.
*Inclusion criteria: Vaginal pH more than 5.0 at baseline.1
†p<0.0001 in all studies
Patients reported statistically significant* improvements in moderate to severe vaginal dryness with Osphena®3
Osphena® relieved vaginal dryness symptoms by Week 12.1,3
In a multicenter, double-blind, Phase 3 clinical trial in 631 women† with moderate to severe vaginal dryness due to menopause, Osphena® significantly improved symptoms of vaginal dryness at Week 12 (-1.29 vs. -0.91 placebo; p<0.0001).1,3
From Weeks 4 (secondary endpoints) to 12 (primary endpoints), an increasing number of patients reported feeling improvements in the MBS vaginal dryness severity score versus placebo.
At baseline, women rated their most bothersome symptom of vaginal dryness on a 4-point scale: 0=none; 1=mild; 2=moderate; 3=severe.3
- A 3-point improvement means a change from severe dryness to no dryness. Only patients who had severe dryness at baseline could report a 3-point change.
- A 2-point improvement could be a change from severe to mild dryness, or from moderate to no dryness.
Changes in vaginal dryness severity scores (ITT population)**3
ITT: intent to treat
*p<0.0001
†Women who reported moderate or severe vaginal dryness as their most bothersome symptom, who had 5% or lesser superficial cells on their vaginal wall smear and a vaginal pH of more than 5.0 were eligible to participate.
‡Assessed on a 4-point scale (0, none; 1, mild; 2, moderate; 3, severe) using a validated, patient self-assessment of VVA questionnaire.
§Secondary endpoints.
¶Responders defined as those with improvements from baseline in the maturation value of 10 points, in vaginal pH of 0.5, and in the most bothersome symptom of vaginal dryness of 1 point.
**Similar results are seen in the mITT population.
Common side effects may include:1
- Hot flashes
- Vaginal discharge
- Muscle spasms
- Hyperhidrosis
- Night sweats
- Headaches
- Vaginal hemorrhage
By Week 12:3
twice as many women taking Osphena® saw improvements in vaginal dryness† vs. those taking placebo (odds ratio 2.23, 95% CI: 1.62–3.06) with Osphena®; and
five times as many Osphena® patients responded to therapy¶ vs. those taking placebo (31.5% vs. 6.0%; p<0.0001).
Patients reported statistically significant* improvements in moderate to severe dyspareunia after treatment with Osphena®1
Osphena® relieved dyspareunia symptoms by Week 12.1
In two randomized, double-blind, placebo-controlled, parallel-group, Phase 3 studies in women† with moderate to severe dyspareunia due to menopause, Osphena® significantly improved patients’ most bothersome symptom of moderate to severe dyspareunia.1
Change in dyspareunia severity score from baseline to Week 12 (LOCF; mITT population)1
mITT: modified intent to treat; LOCF: last observation carried forward; LS: least squares; SE: standard error
*p=0.0012, p<0.0001
†Women who reported moderate or severe dyspareunia as their most bothersome symptom, who had 5% or lesser superficial cells on their vaginal wall smear and a vaginal pH of more than 5.0 were eligible to participate.
Osphena® is contraindicated in patients with:1
- Undiagnosed abnormal genital bleeding
- Known or suspected estrogen-dependent neoplasia
- Active deep vein thrombosis (DVT), pulmonary embolism (PE), or a history of these conditions
- Active arterial thromboembolic disease (for example, stroke and myocardial infarction [MI]), or a history of these conditions
- Hypersensitivity (for example, angioedema, urticaria, rash, pruritus) to Osphena® or any of its ingredients
- Known or suspected pregnancy
- Osphena Prescribing Information. January 2019.
- Data on file. Duchesnay USA Inc.
- Archer DF, Goldstein SR, Simon JA, et al. Efficacy and safety of ospemifene in postmenopausal women with moderate-to-severe vaginal dryness: a phase 3, randomized, double-blind, placebo-controlled, multicenter trial. Menopause. 2019;26(6):611–621.
- Bachmann GA, Komi JO; Ospemifene Study Group. Ospemifene effectively treats vulvovaginal atrophy in postmenopausal women: results from a pivotal phase 3 study. Menopause. 2010;17(3):480–486.