Monday, 29 April 2013

FDA Approved Osphena: A New Medication for Painful Sex in Postmenopausal Women

Look What's New
Ospemifene (brand name Osphena) is a medication recently approved by the FDA for dyspareunia treatment in postmenopausal women. The medication will be available in June, 2013.

Dyspareunia is a broad term meaning painful sex in females. There are many causes of dyspareunia. One major cause is menopause. During menopause, a woman's body stops producing estrogen and progesterone. This results in thinning of the vaginal lining, with dryness, itching, burning, discharge, and even cracking, resulting in pain during sexual intercourse. Up to 40% of postmenopausal women may have these symptoms, a clinical sydrome also known as atrophic vaginitis. Ospemifene mimics the action of estrogen on the vagina. In some ways it may be a "pink Viagra", because it can enable an older person who is unable to have sex due to a medical condition to be able to enjoy sex again.

Comparing ospemifene with other treatments for dyspaureunia

1) Vaginal lubricants. This is by far the safest option, outside of doing nothing. Using a lubricant such as Replens or Astroglide 2-3 times a week can be helpful for some women, but it is not as effective as hormone replacement. Vaginal lubricants can also be messy and inconvenient.

2) Estrogen/progesterone replacement. This is highly effective, and can take a variety of forms, including pills, vaginal creams, and dissolving vaginal rings. Typically, taking pills is reserved for patients who also have disabling hot flashes, as estrogen and progesterone by mouth raises the risk for breast cancer, stroke, and blood clots.

We do not know for sure about the risks for these complications for hormones delivered via the vagina. It is thought that the risk is less than for orally given hormones.

"Bioavailable" hormones have been popularly promoted to be safer than conventional hormone replacement but there is no scientific data supporting this claim.

3) Ospemifene. This is also very effective. The advantages of ospemifene over hormone replacement are unclear, except you take it by mouth instead of in the vagina. This may be important if you have a hard time manipulating a ring or reaching your vagina (if you have severe hand/wrist/elbow arthritis, or if you are obese, for example).

The current studies of ospemifine are not large enough to compare the risks of breast cancer, blood clots and strokes with hormone replacement.

You should not take ospemifene if:

1) You are not menopausal. If you are still having your monthly cycle, then your own body's hormones will work better than ospemifene.

2) Your main problem is low libido and your vagina does not hurt. Ospemifeme does not treat libido, only vaginal pain, and it does have side effects.

3) Your pain is not from a thin vaginal lining. A regular pelvic exam can easily tell your provider whether you have atrophic vaginitis.

4) Your pain is adequately relieved by vaginal lubricants. These methods carry less risk for side effects. Unfortunately, alternative medicine therapies such as herbs and soy do not seem to work for this condition.

5) You have vaginal bleeding and you do not know the cause. Ospemifene was studied for only one year in a limited number of patients before gaining FDA approval. Although there were no cases of endometrial cancer during that one year, ospemifene could cause an existing cancer to grow. We do not know whether there may be a slight increase in the risk of endometrial cancer, particularly over longer periods of use.

6) You have had or currently have breast cancer. Ospemifene has been shown to possibly retard the growth of breast cancer in animals. It did not seem to cause breast cancer in the clinical trials leading to FDA approval. However, this is not proof that it is safe enough to use in breast cancer patients.

7) You have severe hot flashes. Ospemifene has been shown to worsen hot flashes. If you don't think you could handle hot flashes worse than the ones you have now, this is not the drug for you.


Bachman, Gloria A., and Nicole S. Nevadunsky. "Diagnosis and Treatment of Atrophic Vaginitis." American Family Practitioner 61.10 (2000): 3090-096. Print.

Hill, D. Ashley, and Susan Hill. "Counseling Patients About Hormone Therapy and Alternatives for Menopausal Symptoms." American Family Practitioner 82.7 (2010): 801-07. Print.

Portman, D. J., G. A. Bachmann, J. A. Simon, and Ospemifene Study Group. "Ospemifene, a Novel Selective Estrogen Receptor Modulator for Treating Dyspareunia Associated with Postmenopausal Vulvar and Vaginal Atrophy." Menopause (n.d.): n. pag. 28 Jan. 2013. Web.

Simon, J. A., V. H. Lin, C. Radovich, G. A. Bachmann, and Ospemiifene Study Group. "One-year Long-term Safety Extension Study of Ospemifene for the Treatment of Vulvar and Vaginal Atrophy in Postmenopausal Women with a Uterus." Menopause(n.d.): n. pag. 8 Nov. 2012. Web.


1 comment:

  1. Charles Runels, MD14 November 2013 at 01:25

    There's a new treatment for dyspareunia to cause stem cells to generate new healthy tissue. The procedure is called o-shot which has been very effective with my patients. Hope this helps.