11 Facts About Osphena (ospemifene) | Sheena Gurai, PharmD | RxEconsult
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11 Facts About Osphena (ospemifene) Category: Women's Health by - February 13, 2014 | Views: 41250 | Likes: 3 | Comment: 0  

Facts about OsphenaThe body maintains itself through a delicate balance of communication signals between tissues. When signals change, the body’s functioning and structure can also change. A lack of estrogen signaling in women results in vaginal and vulva tissue breakdown, known as vulvovaginal atrophy (VVA). These low estrogen levels may be the result of:

  • Menopause: due to aging when ovaries stop producing estradiol and progesterone
  • Surgical menopause: such as bilateral oophorectomy—the removal of both ovaries
  • Gonadotropin releasing hormone (GnRH) agonists: used to manage conditions such as endometriosis and uterine leiomyomata
  • Hypothalamic amenorrhea: caused by excessive exercise, disordered eating, or the postpartum state
  • Cancer treatments which remove ovaries or render them inactive: such as surgery, pelvic radiation therapy, chemotherapy, or endocrine therapy.

A lack of estrogen in vaginal tissues leads to decreased vaginal blood flow, thin, pale, and dry vaginal and vulva tissue, a narrow and shortened vagina with less elasticity and lubrication, increased vaginal pH, and petechiae (small spots due to minor hemorrhage). Forty-five to 60% of postmenopausal women report experiencing VVA symptoms. Commonly reported symptoms include dryness, irritation of vulva, burning, dysuria (painful urination), dyspareunia (pain associated with sexual intercourse), and vaginal discharge.

Dyspareunia is the result of both thinning of the vaginal/vulva tissue as well as a lack of lubrication. The prevalence of painful intercourse ranged from 8 to 22% in a systematic review of 54 studies (35,973 women) on dyspareunia by the World Health Organization.

Osphena (ospemifene) is an estrogen-like molecule FDA approved for the treatment of moderate to severe dyspareunia (painful sex) due to menopause. Osphena acts like estrogen on vaginal tissues to make them thicker and less fragile, resulting in a reduction in the amount of pain women experience during sexual intercourse.

Here are 11 facts you should know about Osphena:

Osphena for women is not like Viagra for men

Osphena is used to treat pain associated with sexual activity by repairing vaginal tissues and improving dryness. Viagra is FDA approved for men with erectile dysfunction, a blood-flow condition resulting in the inability to develop or maintain an erection with sexual activity. Erectile dysfunction is not associated with physical pain like that found with vaginal tissue breakdown. Viagra in women may be used to treat a different condition unrelated to tissue breakdown known as female sexual arousal disorder.

Osphena does not directly increase libido

Libido, or sex drive, is determined by biological, psychological, and social factors. The regeneration of vaginal tissues leads to less painful sexual activity and may be linked to psychological improvement in sexual desire.

Osphena has similar effects to oral hormonal estrogen therapy

Estrogen is the most effective treatment for moderate to severe symptoms of vaginal atrophy by restoring the normal vaginal acidic pH and bacteria, thickening the skin layer, increasing vaginal secretions, and decreasing vaginal dryness. Oral hormonal estrogens also promote growth in breast tissue, bone mass, and the endometrium. Osphena is a selective estrogen receptor modulator (SERM) that promotes growth of some tissues such as in the vaginal canal, bone, and endometrium while having a neutral effect or blocking growth in others, such as the breast.

Osphena should be considered after lubricants and moisturizers

Treatment of choice for vulvovaginal atrophy is based on severity of symptoms. Nonhormonal lubricants and moisturizers are preferred, after which low-dose vaginal estrogen products are used. Vaginal estrogen products are applied directly to vaginal tissues limiting side effects and increasing efficacy compared to estrogens. If a patient prefers nonvaginal products and symptoms are moderate to severe, options include Osphena or estrogen pills or patch.

Osphena improves dyspareunia over placebo (no treatment) by week 12 of treatment

  • 38% of Osphena treated patients reported no vaginal pain with sexual activity versus 28.1% with placebo
  • 25.1% of Osphena treated patients reported mild vaginal pain with sexual activity versus 19.2% with placebo
  • On a 4-level pain scale (none, mild, moderate, severe), 52.8% of participants reported an improvement of 2-3 levels with Osphena use versus 38.8% with placebo.

Clinical trials did not report improvement in other VVA symptoms or irritation of vulva, burning, dysuria (painful urination), or vaginal discharge. One study reported improvement in vaginal dryness.

Osphena improves dyspareunia symptoms by improving vaginal cell health and decreasing pH

In a total of 1772 patients Osphena was compared to placebo with the following results:

  • Immature cells were decreased by 37.5% more than placebo
  • Superficial, healthy cells increased by 9.24% over placebo
  • Vaginal pH was decreased by 0.89 more than placebo.

Osphena is associated with serious side effects

Osphena carries the same warnings as estrogen and SERM therapies. It may increase the risk of stroke, coronary heart disease, thromboembolism (blood clots), endometrial cancer, and breast cancer. Out of 1000 women

  • Thromboembolic stroke (stroke due to clot) occurred in 0.72 women on Osphena versus 1.04 with placebo
  • Hemorrhagic stroke occurred in 1.45 women on Osphena versus 0 with placebo.
  • Deep vein thrombosis (blood clot) occurred in 1.45 women on Osphena versus 1.04 with placebo

The most commonly reported side effect was hot flushes (7.5% in Osphena versus 2.6% in placebo). No studies have compared the risks of using Osphena to the risks of estrogen therapy.

Also Read: Osphena (ospemifene) Cost, Dosage, Side Effects, Uses, and Drug Interactions

Osphena may contribute to the development of endometrial cancer in women with a uterus

Current clinical studies do not show significant growth of endometrial tissue or cases of endometrial cancer with exposure to Osphena for up to 52 weeks. However, long-term safety data is lacking. Estrogen therapy without progestin increases the risk of endometrial cancer in women with a uterus even 8-15 years after estrogen therapy is discontinued. Adding progestin has been shown to reduce the risk of endometrial hyperplasia, though progestin use with Osphena has not been evaluated. Vaginal bleeding should be reported immediately and therapy should be limited to the shortest duration consistent with treatment goals.

Osphena is not approved for breast cancer or osteoporosis treatment

To date, Osphena has not been evaluated in cancer or osteoporosis patients and is contraindicated in known or suspected estrogen-dependent cancers such as breast, ovarian, and endometrial cancer. Preliminary studies show Osphena blocks estrogen effects in breast tissue and also prevents bone breakdown just like tamoxifen and raloxifene, two SERMs used in breast cancer and osteoporosis therapy. Future studies may find additional indications for Osphena therapy.  

Osphena is different than other drugs in the Selective Estrogen Receptor Modulator (SERM) class

Each SERM drug has different effects on various tissues. Amongst drugs classified as SERMS (Osphena, tamoxifen, raloxifene, bazedoxifine, and toremifene) Osphena is the only SERM that activates estrogen receptors in vaginal tissue. This effect allows it to improve dyspareunia associated with VVA.

Osphena was only studied in postmenopausal women

There may be differences in the success and safety of Osphena treatment based on specific patient characteristics. The majority of study patients were postmenopausal women (age 40-80 years) with a chief complaint of dyspareunia due to vulvovaginal atrophy.

Recommended Reading

Does Viagra, Cialis, and Levitra Work for Women?

Effect of Viagra, Cialis, and Levitra in Females With Various Conditions 

Alternative Medicines for Menopause Symptoms

A Review of Contraceptives and Selecting A Method of Contraception

References

Bachmann GA, Komi JO. Ospemifene effectively treats vulvovaginal atrophy in postmenopausal women: results from a pivotal phase 3 study. Menopause. 2010 May-Jun;17(3):480-6.

Kangas L, Unkila M. Tissue selectivity of ospemifene: pharmacologic profile and clinical implications. Steroids. 2013 Dec 11;78(12-13):1273-80.

Management of symptomatic vulvovaginal atrophy: 2013 position statement of The North American Menopause Society. Menopause. 2013 Sep;20(9):888-902.

OSPHENA [prescribing information]. Florham Park, NJ: Shionogi Inc; 2013.

Pinkerton JV, Thomas S. Use of SERMs for treatment in postmenopausal women. J Steroid Biochem Mol Biol. 2013 Dec 25. doi: 10.1016/j.jsbmb.2013.12.011.

Portman DJ, Bachmann GA, Simon JA, and the Ospemifene Study Group. Ospemifene, a novel selective estrogen receptor modulator for treating dyspareunia associated with postmenopausal vulvar and vaginal atrophy. Menopause. 2013 Jun;20(6):623-30.

Santoro N, Komi J. Prevalence and impact of vaginal symptoms among postmenopausal women. J Sex Med. 2009;6(8):2133–2142.

Soe LH, Wurz GT, Kao CJ, Degregorio MW. Ospemifene for the treatment of dyspareunia associated with vulvar and vaginal atrophy: potential benefits in bone and breast. Int J Womens Health. 2013 Sep 25;5:605-611.

 

The material on this site is for information only and is not a substitute for medical advice, diagnosis or treatment provided by a qualified healthcare provider.

 

 


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