Relationships can hold a lot of questions and conversations about if it’s serious enough if there is a potential for a future, marriage, children, etc. These questions can be daunting and sometimes break the relationship.
But if you are in a committed relationship that could essentially lead to a family and a future together, which means you have to consider your options with birth control. Having unprotected sex can lead to pregnancy and disease, but if you are in that relationship where you want to go that route, you’ll want to consider other options as well.
Even if the relationship isn’t long term, you might still want to go that route, but you’ll want to keep yourself safe in other ways as well by ensuring that your partner is clean.
But what options do you have to protect yourself from unintended pregnancies? There are oral birth control pills, the implant, the NuvaRing, IUD’s and also spermicides and condoms.
Most of the options contain hormones, which some women do not like because of how it affects their bodies and their minds as well. It’s hormones and some do not agree with it physically.
There is also the IUD Paragard which is non-hormonal, and a lot of women are comfortable with that (plus it’s good for 10 years), and it’s an option but others aren’t too sure about using it.
Then there are spermicides, which are made for women to use. These are products that kill the sperm so that it has no chance of reaching the egg as long as it’s used correctly.
Evofem has come out with a new product, Amphora, a spermicide that can help prevent pregnancy. They are going along with the clinical trial to determine its effectiveness.
Who is Evofem
Their full name is Evofem Biosciences and they are paramount in creating products that are filling in the blanks when it comes to sexual and reproductive health.
While they currently have the vaginal contraceptive gel, they also have the Nestorone Ring which is also currently in clinical trials.
One benefit of Evofem is that the company is run by a female, Saundra Pelletier. While this may seem like something that is trivial or sounds sexist it’s not.
It means however that someone who is inherently familiar with the female body and its needs is going to be able to give direct feedback as to the direction of the company.
Not Just for Preventing Pregnancy
Evofem is running their AMPOWER study to determine if Amphora can do more than prevent pregnancy. It works by maintaining “the pH of the vagina to inhibit sperm motility and to form a layer of gel over the vagina and cervix.”
The study is no small feat either. There are about 1350 women throughout the US participating in this study.
One of the additional benefits they are claiming and hoping to prove is that it prevents Chlamydia/Gonorrhea. The women in this trial will be followed for 5 month period in total to determine it’s effectiveness.
They are also going to be reviewing its effectiveness in reducing recurring bacterial vaginosis. For one product, they are making a lot of claims.
They say that with Amphoras ability to maintain the proper balance of bacteria in the vagina, which is the primary reason for contracting bacterial vaginosis in the first place.
Why this is Important
Having products that are catered to women, by women, is something that most are looking for; new options to allow them to prevent pregnancy, to prevent disease, but without altering their natural cycle at the same time.
According to sources, unplanned pregnancy in the US is around 45 Percent which for an industrialized world, is pretty high if you ask me.
If you really take a look at the options out there, they are all pretty much different uses for the same hormones, except of course for Paragard, which is based on the use of copper.
They are also trying to change the view of Amphora, which is different than other gels because it doesn’t cause irritation, and irritated skin in those areas can be a breeding ground for contracting a disease.
Plus, it doesn’t cause any side effects like hormonal birth controls do. And the best part, a woman can control when she uses it, if she does, and it’s in her hands, both literally and figuratively.
But know that the road to getting this FDA approval for the drug is not short and it’s surely not cheap either. It can cost upwards of almost $650 million and range into the billions, which is scary.
But if they succeed they are hoping to bring it to the market in 2019. But we have to remember that the drug started it’s long journey in the mid ‘90’s.
Saundra Pelletier is the perfect person to be running a company of this magnitude that is looking to create products by women for women.
Her child was an unplanned pregnancy and she is hoping to help prevent that for other women, and also have products in the hands of those who are less fortunate, not just women in the US.
A contraceptive like this could mean the difference for many women of not having any options and having a way to protect themselves.
But this is the second time for Amphora to get approved by the FDA, and they are looking for a win on this one. So hopefully they get through the trials because an offering like this could be amazing for the future of women.
- Evofem. Evofem Biosciences Announces First Patient Enrolled in a Clinical Trial to Determine the Effect and Duration of Amphora Gel on Vaginal pH – Evofem. http://www.evofem.com/news-archive/evofem-biosciences-announces-first-patient-enrolled-clinical-trial-determine-effect-duration-amphora-gel-vaginal-ph/
- Evofem. Products in Development – Evofem. http://www.evofem.com/products/
- See above #3
- Inc. Why this Woman Might Disrupt the Condom (and the Pill). https://www.inc.com/magazine/201711/kimberly-weisul/evofem-contraceptive-gel.html
- See above #6
- See above #6