FAQs

There are an estimated 13 MILLION women in the post-menopausal age group in the UK.¹ With life expectancy increasing,² and the age of menopause not seeming to change much^30, the number and proportion of post-menopausal women in the general population is increasing.

As many as 60% of post-menopausal women suffer from the symptoms of VVA, such as vaginal dryness and dyspareunia.⁴ And yet the majority of those (63%) do not know that vaginal discomfort is a chronic condition,⁵ the underlying cause of which can usually be treated. 

Symptoms of VVA can impair a woman’s everyday life, including her sleep and temperament.^5,6 The sexual relationships and physical intimacy of some post-menopausal women and their partners can also be significantly affected by symptoms of VVA, which can contribute towards a woman’s reduced self-esteem and emotional wellbeing.^6,7

Senshio is indicated for post-menopausal women with moderate to severe symptomatic vulvovaginal atrophy (VVA).⁸

The recommended method of administration is one tablet swallowed whole once daily with food and it should be taken at the same time each day.⁸

Ingesting the tablet with food enables the active ingredient to be better absorbed

If a dose is missed it should be taken with food as soon as the patient remembers. A double dose should not be taken in the same day.⁸

VVA is a chronic condition, characterised by a progressive decline in oestrogen levels, secondary to the menopause.¹⁰

As with many other chronic conditions, to maintain efficacy, Senshio treatment should be taken on a continuous basis and under the supervision of a physician.⁸

The effects on vaginal epithelium upon cessation of Senshio therapy have not been formally studied. However, if a patient stops using Senshio, the symptoms of VVA may return.

Senshio does not contain hormones, therefore unlike hormonal treatments, Senshio can be prescribed to women with a personal history of oestrogen dependent breast cancer, but it should only be used to treat VVA after the treatment for breast cancer has been completed, including any adjuvant treatment.⁸

Senshio has not been formally studied in women with a prior history of breast cancer. No data are available on its concomitant use with medicinal products used in the treatment of early or advanced breast cancer.⁸

Senshio can be combined, if desired, with non-hormonal vaginal moisturisers or lubricants.

In the Senshio pivotal trials, women were provided with a non-hormonal lubricant to be used as desired. Fewer women used the lubricant towards the end of treatment in the Senshio 60mg group vs the other groups,¹¹ suggesting that there was less need for the lubricant in this group.^11,27,28

As the restorative effects of Senshio on the vaginal epithelium are gradual, it may be useful for a woman to continue to use non-hormonal moisturisers or lubricants for symptom relief at the start of Senshio treatment.¹¹

Senshio acts by imitating some of the beneficial effects of oestrogen in the vagina, addressing the underlying causes of vulvovaginal atrophy, and improving symptoms such as dryness and dyspareunia vs. placebo.^8,11,12

Senshio is a SERM (selective [o]estrogen receptor modulator) whose biological activities are mediated by competitively binding with oestrogen receptors. In some tissues, this causes the blocking of the effects of oestrogen (antagonism) and in other tissues, this causes the activation of the effects of oestrogen (agonism). In the vagina, Senshio stimulates the natural growth of the vaginal epithelium, increasing the cellular maturation and mucification of the vaginal epithelium.^8,12

By 12 weeks, over 75% of patients saw an improvement in symptoms of vaginal dryness and dyspareunia from baseline.¹⁴

Senshio’s effects are tissue-selective: It has a neutral effect on the endometrium, an agonist effect on the bone and antagonist effect on the breast.¹²

The most distinguishing effect of Senshio is its significant oestrogenic effect on vaginal epithelium. Pre-clinical data have shown that Senshio also has a neutral effect on the endometrium, an agonist effect on the bone and antagonist effect on the breast. There are no clinical data assessing whether this pre-clinical data would translate into Senshio having a protective effect against breast cancer.^12,13

Senshio has not been formally studied in women with a prior history of breast cancer. No data are available on its concomitant use with medicinal products used in the treatment of early or advanced breast cancer. Therefore Senshio should be used for the treatment of VVA only after the treatment of breast cancer, including adjuvant therapy, has been completed.⁸

Systemic HRT

Indications for which systemic HRT (hormone replacement therapy) is most commonly used:¹⁵

• To relieve vasomotor symptoms
• To improve urogenital symptoms
• To prevent osteoporosis

Systemic HRT is not recommended in women who only have vaginal symptoms.¹⁶

Local vaginal oestrogen

Local oestrogens are the generally accepted current treatment for moderate-to-severe post-menopausal VVA.¹⁵However, there are many women who are not candidates for local oestrogens, and these women need another effective option.⁹

Some women who use both over-the-counter and prescription oestrogen products:^7,9,16

• May not achieve relief from the symptoms of VVA
• May be dissatisfied with currently available treatments
• Or may suffer from adverse events

Studies show that issues such as safety concerns, or dissatisfaction with, their treatment, may affect women’s adherence to prescribed, recommended, or self-initiated therapies and increase the burden of VVA.⁷

Senshio is indicated for post-menopausal women with moderate to severe symptomatic vulvovaginal atrophy (VVA).⁸ Senshio therefore provides a choice for women with VVA.¹⁵

There are no direct comparative studies between Senshio and HRT in either form (systemic or local vaginal therapy).

An indirect historical comparison of Senshio vs. local vaginal oestrogen in moderate/severe VVA has shown that Senshio has an efficacy, safety, and tolerability profile comparable to, or better than, local vaginal oestrogens on the treatment of VVA.¹⁷

Senshio is indicated for the treatment of moderate to severe symptomatic vulvovaginal atrophy (VVA) in post-menopausal women.⁸

In clinical practice, the most important parameter for assessing efficacy of a treatment for VVA is patient-reported improvement in symptoms. This requires assessment of symptoms at baseline, and re-evaluation of symptoms at follow-up.^8,10,18,19

Other measures could include:

• Improvement in signs on visual examination (pallor, redness, petechiae, dryness, friability)
• Improvement in vaginal pH
• Improvement in vaginal health index (VHI)

Analysis of primary efficacy included change from baseline to week 12 in the following four co-primary endpoints:^{11, 27, 28}

• percentage of superficial cells on the vaginal smear
• percentage of parabasal cells on the vaginal smear
• vaginal pH
• self-assessed most bothersome moderate to severe symptom (MBS) of vaginal dryness or dyspareunia (more specifically, vaginal pain associated with sexual activity).

Additional secondary efficacy endpoints at week 12 included:²⁰

• change from baseline in total score of the FSFI (Female Sexual Function Index)
• change from baseline in the domains of the FSFI (Arousal, Desire, Orgasm, Lubrication, Satisfaction, and Pain)

Secondary efficacy assessments at weeks 12, 26 and 52 included:¹⁸

• changes from baseline for visual evaluation of the vagina (petechiae, pallor, friability and dryness or redness in vaginal mucosa)
• percentages of superficial cells and parabasal cells in the maturation index and in vaginal pH

Primary efficacy endpoints:

• Senshio significantly improves vaginal physiology by 12 weeks vs. placebo (p<0.001)^8,11,27,28
  • Significantly increased percentage of superficial cells vs. placebo
  • Significantly decreased percentage of parabasal cells vs. placebo
  • Significantly decreased vaginal pH vs. placebo
• Senshio significantly decreases vaginal dryness and dyspareunia by 12 weeks vs. placebo (p<0.05)¹¹
• Greater improvements observed in all six domains of the Female Sexual Function Index for Senshio vs. placebo– Arousal, Desire, Orgasm, Lubrication, Satisfaction, and Pain (p<0.05)²⁰

After 1 year with Senshio:

• Improvements in vaginal physiology maintained – increased superficial cells, decreased parabasal cells, decreased vaginal pH vs. placebo (p<0.0001)^8,18
• Visual evaluation of the vagina demonstrated statistically significant improvements in each of the five parameters – petechiae, pallor, friability, vaginal dryness in the mucosa and vaginal redness in the mucosa (p<0.0001)¹⁸
• Almost 80% of Senshio patients had no signs of VVA on visual examination after 1 year of treatment vs. approx. 30% on placebo (n=±290/363 Senshio; n=±19/63 placebo)¹⁸

Various assessment tools have been used to measure factors associated with female sexual dysfunction (FSD). The Female Sexual Function Index (FSFI) was developed as a brief, easy-to-administer, self-report tool for assessing key dimensions or domains of sexual function and quality of life (Arousal, Desire, Orgasm, Lubrication, Satisfaction, and Pain) in various populations of women.²⁰

In the Senshio phase-3, randomized, double-blind, 12-week trial (n=919), the secondary endpoint of Senshio’s effect on Sexual Function was assessed. Study participants completed the FSFI questionnaire at baseline, Week 4, and Week 12. The questionnaire consisted of 19 questions, each rated on a scale ranging from 0 to 5 or 1 to 5, with 0 indicating no sexual activity in the past month.²⁰

The FSFI questionnaire is available at http://fsfi-questionnaire.com [accessed June 2024]

Senshio’s effects are gradual, with physiological effects generally appearing first and improvements in symptoms following.^11,21

Senshio’s effect on vaginal physiology (maturation index, pH) was statistically significant at 4 weeks vs. placebo, but continued to improve up to 12 weeks.¹¹

By 12 weeks Senshio showed a significant improvement in the vaginal physiology vs. placebo, and also showed significant improvements in vaginal dryness and dyspareunia vs placebo.¹¹

It is recommended to take Senshio on a daily basis to maintain benefits and relief of symptoms. The benefits (improvement in vaginal physiology, vaginal dryness & dyspareunia) were seen within 12 weeks of taking Senshio vs placebo.^8,11,18

This has not been studied, but if Senshio treatment is stopped, it might be that the vagina will develop signs of atrophy again, as it would have done without Senshio treatment.

The most common side effects reported with the use of Senshio in phase II/III clinical studies were as follows:^8,22

• Vulvovaginal candidiasis/mycotic infections
• Hot flushes
• Muscle spasms
• Vaginal discharge, genital discharge
• Headache
• Rash (includes rash erythematous, rash generalised)

The most frequently reported adverse reaction was hot flushes (7.5% compared with 2.6% with placebo), which led to discontinuation in 1% of women.^8,22

Senshio is absorbed systemically. It acts on the oestrogen receptors which are ubiquitously distributed in many tissues throughout the body. The ‘tissue selectivity’ arises from its different effects in different tissues, specifically its highly positive agonistic (oestrogenic) effect, which only occurs in the vagina.^8,12

However, when circulating in the blood, its effects can also appear in tissues and organs other than the vagina.

Senshio exerts:^12,23

• A minimal effect on the endometrium
• An antagonist effect on the breast
• An agonist effect on the bone, which is common in most SERMs

In preclinical studies Senshio is shown to exert an anti-oestrogenic, anti-proliferative effect in breast tissue.¹³

In clinical studies (results of mammograms and breast palpations of double-blind placebo-controlled studies):^8,22

• No abnormal breast-related findings identified for Senshio
• No clinically significant changes in mammography after 1 year of treatment
• There were two cases of breast cancer in the placebo group, but no cases of breast cancer in the group treated with Senshio 60 mg/day

Senshio has not been formally studied in women with a prior history of breast cancer. No data are available on its concomitant use with medicinal products used in the treatment of early or advanced breast cancer. Therefore Senshio should be used for the treatment of VVA only after the treatment of breast cancer, including adjuvant therapy, has been completed.⁸

Senshio’s safety on the endometrium has been assessed by biopsies in various clinical studies (randomised, double-blind and placebo-controlled) at weeks 12 and 52.

• No significant change in endometrial histology within 1 year^8,24,25
  
  • No statistically significant difference between Senshio and placebo in incidence of endometrial thickness ≥5mm at 1 year²⁴
  • There was <1mm difference in the mean change from baseline in endometrial thickness at 1 year between Senshio and placebo^8,24,25
• No difference in vaginal bleeding with Senshio compared with placebo^8,24
• In the group treated with 60 mg of Senshio for 12 months, only 1 case of simple hyperplasia without atypia was observed 3 months after the patient took the final dose of the drug^8,24
• No cases of endometrial cancer were observed^8,24

There was no difference in the incidence rate of VTE (venous thromboembolic events) and CV (cerebrovascular events) with Senshio vs. placebo across all placebo-controlled clinical trials of Senshio.^25,26

Incidence per 1000 women years (95% CI) on Senshio 60 mg

The relative risk is 1.0⁸

There are certain class effect risks associated with SERMs: The risk of VTE cannot be excluded with SERMs. Senshio should be discontinued at least 4-6 weeks prior to and during prolonged immobilisation. The risk of CV events is possibly increased with other SERMs. The risk of CV events associated with Senshio cannot be excluded. This should be considered when prescribing Senshio for post-menopausal women with a history of stroke or other significant stroke risk factors. If VTE develops after initiating therapy, the drug should be discontinued.⁸

Senshio 60mg once daily oral tablet has been approved for use in the United States since February 2013, and since January 2015 in Europe.²⁶

• 128,995 patient-years of cumulative post-marketing exposure in USA and EU²⁶
• Over 47 million tablets²⁶

Together with pharmacovigilance reporting, a Post-Authorisation Safety Study (PASS) was undertaken to asses the incidence and risk of various side effects associated with ospemifene use in a real world setting. ²⁹

Post-marketing surveillance up to 3.5 years and the 2 year results from the PASS confirm that there has not been an increase in the risk of thrombosis, stroke, vaginal bleeding or endometrial hyperplasia with Senshio to date (January 2019).²⁶

The PASS published in 2022 found no increase in risk of VTE or other adverse events with use of ospemifine in post menopausal women. ²⁹

• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. of the SmPC⁸
• Active or past history of venous thromboembolic events (VTEs), including deep vein thrombosis, pulmonary embolism and retinal vein thrombosis⁸
• Unexplained vaginal bleeding⁸
• Patients with suspected breast cancer or patients undergoing active treatment (including adjuvant therapy) for breast cancer⁸
• Suspected or active sex-hormone dependent malignancy (e.g. endometrial cancer) ⁸
• Patients with signs or symptoms of endometrial hyperplasia; safety in this patient group has not been studied. ⁸

Please consult the Senshio SmPC for further details.