The FDA has approved a prescription medication, ospemifene (Osphena), to treat the problem of vaginal dryness and pain during intercourse in women who are undergoing menopause.
Osphena® is the only FDA-approved oral pill indicated for the treatment of moderate to severe dyspareunia (painful sex), a symptom of vulvar and vaginal atrophy (VVA), due to menopause.
Due to this effect of the product, it has been labeled as “the sex pill of older women.” As typically happens when a new drug gets FDA approval the PR machine for the company goes into overdrive flooding the media with press releases.
Since sex sells, well, Osphena received a fair amount of air time and print space. Headlines like FDA-Approved “Female” Viagra might lead someone to believe that Osphena is freaking amazing. Which, of course, it is not.
Rather than a vaginal cream or tablet, it is a pill to be taken by mouth. Although ospemifene is not estrogen, it acts similar to estrogen and does carry some of the same dangers.
Osphena is supposed to work by increasing superficial cells, decreasing parabasal cells (two types of vaginal cells) and reducing vaginal pH.
The manufacturer warns that there is a possibility that Osphena might increase the risk for endometrial cancer (cancer of the lining of the uterus) or strokes and blood clots deep within the veins. The manufacturer recommends that women with breast cancer or liver impairment not take Osphena.
Each pill of Osphena contains 60 mg of ospemifene, the main ingredient in the product. Ospemifene is produced by corporation Shionogi and is an oral medication used for the treatment of pain during sexual intercourse known as dyspareunia.
- 1 Active Ingredients and Their Purpose
- 2 The issues with Osphena
- 2.1 1. Osphena doesn’t guarantee effectiveness and doesn’t solve the problem of painful intercourse completely
- 2.2 2. There are lots of negative reviews about the product
- 2.3 3. Osphena has a lot of drawbacks and potential side effects,
- 2.4 4. Osphena does not work on restoring natural estrogen balance
- 2.5 5. Another issue with Osphena is it doesn’t have ingredients to enhance the female sex drive.
- 3 User reviews on Osphena
Active Ingredients and Their Purpose
The active ingredient in Osphena (ospemifene) an estrogen agonist/antagonist with tissue-selective effects (also called a selective estrogen receptor modulator) that was recently approved for the treatment of dyspareunia associated with vulvar and vaginal atrophy in postmenopausal women.
Osphena is an estrogen agonist/antagonist, meaning on some tissues it acts like an estrogen and on other tissues it acts like an anti-estrogen. It acts like estrogen on the vaginal tissues and the lining of the uterus, but it acts like an anti-estrogen on the breast (note; this is in animal studies).
There are 3 other drugs on the market in the same class (tamoxifen, toremifene, and raloxifene), however, ospemifene is the only one that works on vaginal tissue.
Estrogen is a hormone that plays an important part in a woman’s body – it especially is responsible for developing a woman’s reproductive cycle and it helps keep the vagina healthy.
Since menopause causes the estrogen levels of a woman’s body to decline, physical vaginal changes occur such as vaginal dryness, decreased* vascularity of the vaginal tissues, petechiae, and redness – all of these may result in dyspareunia; otherwise known as painful intercourse.
Reversing or slowing down these vaginal changes is the main purpose of Osphena.
The issues with Osphena
1. Osphena doesn’t guarantee effectiveness and doesn’t solve the problem of painful intercourse completely
Besides, its main ingredient, ospemifene, is like an unnatural estrogen and has many side effects. The product doesn’t solve the problem of painful intercourse completely. The dosage and duration of treatment is not clear. The manufacturer tells about some side effects of Osphena on its website but doesn’t mention the complete list of them.
You are highly recommended to consult your healthcare provider in case if you feel any changes in speech or vision, suffer from sudden severe headaches or pains in your chest or legs. You can also experience weakness, shortness of breath, and fatigue. One should avoid using Osphena in case of unusual vaginal bleeding; cancer (cancer of the uterus or breast); a stroke or heart attack; blood clots; serious liver problems. People who are allergic to Osphena or its ingredients, as well as pregnant women are prohibited to take this product. Women who are going to have surgery should also avoid Osphena.
2. There are lots of negative reviews about the product
“I had high hopes for this medication, however, it was awful! I had the worst headache for four days and nothing would help it go away”
“This product did not work for me. It actually gave me worse hot flashes then before I started taking it”
“Got it for the wife she says don’t waste your money didn’t do anything for her didn’t even give her a headache”
3. Osphena has a lot of drawbacks and potential side effects,
Many or which are very serious, including the following:
It will stimulate the lining of the uterus and if not prevented this could lead to cancer of the uterus. Women with a uterus will need to take an oral drug called progesterone or a progesterone-like drug to prevent this cancer (although a Mirena IUD would also do this).
An increased risk of blood clots
Hot flashes as Osphena works like an antiestrogen on some tissues. Not everyone reports hot flashes, but it is definitely listed as an adverse effect.
Drug interactions. Osphena is metabolized by several liver enzymes that are responsible for the metabolism of other drugs. When two drugs use the same enzyme system side effects and serious adverse reactions are more common.
On the flip side, this interaction can also cause a drug to be metabolized so quickly that it becomes less effective. A prescription for Osphena should prompt a review of your medications with a pharmacist.
4. Osphena does not work on restoring natural estrogen balance
The biggest issue with the Osphena is it does not seem to be an effective formulation to RESTORE the estrogen balance that gets disturbed with aging.
This means that while it contains the ingredient that works similar to Natural estrogen, it doesn’t contain other ingredients that ENCOURAGE your body to make estrogen Naturally. Like the way your body made it , when you were young.
There are other natural hormone balancing ingredients like black cohosh, red raspberry, indole-3-carbinol, damiana, gingko biloba etc. that work on balancing estrogen levels in the body, by strengthening the efficiency of the body’s own endocrine system. (Some of these ingredients work as NATURAL estrogen themselves).
In our opinion, the best estrogen replacement strategy would be to use natural phytoestrogens (that work as Natural estrogen) COMBINED with those ingredients that ENCOURAGE your body’s hormonal system to make estrogen Naturally. We recommend you check out Provestra.
5. Another issue with Osphena is it doesn’t have ingredients to enhance the female sex drive.
In majority of cases, the menopause is associated with vaginal dryness and low libido.
Unfortunately, Osphena only focuses on the “estrogen” part. Not the “libido” part.
Most women fail to understand that while estrogen is linked to libido or sex drive, they are still very different things.
There are other hormones like testosterone, responsible for female libido.
There are countless experiences of women that have been using estrogen creams to manage their menopausal symptoms, that have found out that while the Estrogen cream did help them with the vaginal dryness, but it was unable to help much with the libido.
Their sex drive continued to be negligible or on the low side.
These women then usually opt for testosterone therapies to increase their libido, usually a T gel like Androgel or they use natural herbal supplements like Ginkgo biloba, Mucuna pruriens, Tribulus Terrestris, Epimedium sagitattum etc. to treat the lack of sex drive.
In our opinion, that is one reason we think Provestra is better than Osphena. Because the former takes care of all the female sexual issues including the “estrogen” and “libido”.
Provestra has ingredients that act as natural aphrodisiacs eg. Theobromine, Ginseng, Gingko biloba, Ginger root etc. that increase the female sex drive.
Osphena misses out on such ingredients.
User reviews on Osphena
1. I have been on Osphena for 9 months I had the painful intercourse severe dryness burning just to be completely honest I felt like I had glass in my vagina thats the best way to describe the pain, it took about six months of being on Osphena before I really seen inprovements now a nines months iI feel normal again !
I know ther are side effects but for me my comfort and being able to have my life back is worth it, I couldn’t hardly walk so this wasn’t just about sex, things were so bad everyday task were almost impossibe for me!
I tried other things first I use estrace for 6 mons did not help at all and use replens no help either along with different lubricants nothing work, OSPHENA has helped me and I am thankful for my doctor prescribing it for me!!!
I have used Osphena for nearly 3 years. It works well–vaginal dryness and tender tissues are gone. However, since I worry about cancer and the other complications, for the last year and a half I have only taken one tablet every 3 days. It is enough to help, but hopefully it is not enough to create serious problems.
I am 63 years old. I’ve been on Osphena for 2 years, the only thing it helped with was the burning. Sex is still very painful for me because of the dryness.
I have been taking Ospena for about 6 months or more. The price is too high $250/mo. and not covered by my insurance – VERY UNKIND -But, I have found it to be a wonder drug!
I was concerned about cancer issues, but I would tear my labial tissue by just wiping gently! Sex was a painful and bloody mess even with lube! I was started on Estrace (helped slightly), then Estring (which actually did help a bit) and then was offered Ospena!!!! Within a few weeks (if that) my body started producing vaginal fluid again! I now have sex like I am 26 not 56!
Yes, I am divorced and have met a new man, but so many of my friends say their sex life is OVER due to pain, dryness and discomfort. Women (and their partners) should not have to give up all of the positive health effects of a good and satisfying sexual relationship due to vaginal atrophy (I HATE that word!). We just need to find a way to make this drug more affordable and covered – as necessary – on insurance! I also only take it 2 or 3 times a week to save on money. If I take it the day before sex I am all set! I hope this helps.
Also, I have a spine full of degenerative disc disease and arthritis and I have NOT had an increase in joint pain. Actually the opposite. I am happier and want to walk more and stay more fit… it is the trickle down effect (opps, bad humor).. bottom line – it works!
I’ve been on Osphena for two weeks now, and while intercourse already seems less painful, I find that I’m becoming ridiculously emotional. It’s almost like I’m PMSing, and at 62, that’s totally unacceptable! I can’t take this restless, uneasy irritability
6. After a couple of months, Osphena doesn’t seem to even work as well as the Premarin vaginal cream, plus my hot flashes have greatly increased in intensity. Nothing I have tried has made intercourse comfortable!