FDA clears Natural Cycles as the first digital method of contraception in the US

Natural Cycles became the first and only app to receive FDA clearance as a method of birth control. The app contains an algorithm that calculates the ‘fertile window’ based on basal body temperature (BBT) and menstrual cycle information. It makes the women aware of her ‘fertile days’ to avoid sex or use a barrier method if practicing birth control.

Terri Cornelison, M.D., Ph.D., assistant director for the health of women in the FDA’s Center for Devices and Radiological Health said in a press release, "Consumers are increasingly using digital health technologies to inform their everyday health decisions, and this new app can provide an effective method of contraception if it’s used carefully and correctly." 

"But women should know that no form of contraception works perfectly, so an unplanned pregnancy could still result from correct usage of this device," she added further.

“Natural Cycles can adapt to each woman’s body and, with a high degree of precision and accuracy, determine when she is ovulating,” says Dr. Elina Berglund, a physicist who created the app along with her husband Dr. Raoul Scherwitzl, a postdoctoral researcher.

Natural cycles is just like old times period tracker with some added features. The app requires the women to input her daily basal body temperature recordings and the date of menstruation. LH test result is an optional entry point.

The app’s calendar then labels fertile days as red (when you should abstain or use a condom) and the rest green, when you are “safe.” Using the sensitive thermometer and some mathematics the app claims itself “as good as the pill" at preventing pregnancy.

The app is primarily based on the fact that a woman’s body temperature rises slightly (about 0.4℃) after ovulation and remains slightly elevated throughout the rest of the cycle. The app uses an algorithm that considers body temperature, cycle irregularities, sperm survival, length of menstrual cycle and cycle irregularities. The algorithm learns from previously recorded cycles from the same woman and can provide predictions of her fertility status and upcoming ovulation, LH and menstruation days.

Initially, the app shows a nearly equal number of a green and red day but, as women continue using the app and fed more data, the number of red days is reduced to 8 each month. The app is 99.95% sure before it assigns a day red or green. If in doubt it will go red.

Clinical studies involving 15,570 women found that when used correctly, the failure rate for the app was 1.8%, while with typical use, or women sometimes not using the app correctly, the failure rate was 6.5%. "Based on the strength of our clinical data, we are delighted that the FDA granted De Novo classification for Natural Cycles and look forward to working together with healthcare professionals to offer a digital form of birth control to women in the US," said Elina Berglund.

"Our mission at Natural Cycles is to pioneer women's health with research and passion, and this milestone marks a very important step in that journey."

Natural Cycles received CE mark last year for marketing in Europe and has more than 900,000 registered users worldwide.

Anyone can use it, even women with PCOD or irregular cycles, only these women will have more red days on the calendar than green. Natural Cycles is contraindicated in women in whom pregnancy poses a serious risk to mother or fetus or in those who use other forms of contraception that prevent ovulation.  The method also does not prevent STIs.

The Natural Cycles app can be purchased through the Apple store or Google Play on a yearly subscription basis for $79.99 a year (includes oral basal thermometer) or monthly for $9.99 per month. They also offer a free trial period of 1 month.

Here is a video about Natural Cycles app for healthcare professionals. 

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FDA press release

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World’s first app receives approval as a contraceptive in Europe, could it replace the pill?

Natural Cycles app.

Natural Cycles- is world’s first fertility control app that got a clearance in the European Union including U.K placing it alongside pills, IUDs, and condoms. Natural Cycles is a certified and CE marked medical device of class IIb, intended to be used for contraception.

Elina Berglund Scherwitzl

The app was created by Dr. Elina Berglund, 32, a physicist who was part of the team that found the Higgs boson at Cern in Switzerland, and her husband Dr. Raoul Scherwitzl, a postdoctoral researcher.

“Natural Cycles can adapt to each individual woman’s body and, with a high degree of precision and accuracy, determine when she is ovulating,” says Dr. Elina Berglund

Natural cycles is just like old times period tracker with some added features. Using a sensitive thermometer and some mathematics the app claims itself “as good as the pill" at preventing pregnancy.

The app requires the women to input her daily basal body temperature recordings and the date of menstruation. LH test result is an optional entry point.

The safe and unsafe days 

The app’s calendar then labels fertile days as red (when you should abstain or use a condom) and the rest green, when you’re “safe”.

The app is primarily based on the fact that a woman’s body temperature rises slightly (about 0.4℃)after ovulation and remains slightly elevated throughout the rest of the cycle. The app uses an algorithm that takes into account body temperature, cycle irregularities, sperm survival, length of menstrual cycle and cycle irregularities.  The algorithm learns from previously recorded cycles from the same woman and can provide predictions of her fertility status and upcoming ovulation, LH and menstruation days.

Initially, the app shows a nearly equal number of the green and red days but, as women continue using the app and fed more data, the number of red days are reduced to 8 each month. The app is 99.95% sure before it assigns a day red or green. If in doubt it will go red.

It can be used by anyone, even women with PCOD or irregular cycles, only these women will have more red days on the calendar than green.

efficacy of the app 

A recent clinical study published in the peer-reviewed European Journal of Contraception and Reproductive Health Care recruited 4000 women between ages 18-45 to use this app.[1] The study results showed that for every 100 women who used the app, 7 women got pregnant each year (7% failure rate). CDC statistics quote the failure rate for the pill is around 9%, for injectable contraceptive it’s 6%; for an IUD, it's 0.2% - 0.8%.

Kristina Gemzell Danielsson, from Swedish medical institute Karolinska Institutet. “The efficacy is far below that of intrauterine contraception or implants, but similar to that of the pill when used in real life. The pill which will celebrate its 56 birthdays in March 2017 was a breakthrough that liberated women and changed the way we look at sex.  

Could the app replace pill that has ruled for 56 years.

Natural cycles can help women to plan a pregnancy as well. It is especially useful for women with irregular cycles and PCOD. In fact, it has already helped 5000 Swedish women to conceive under the # HappyPregnant project. Elina Berglund has already launched a similar project in U.K.

The app is currently used by nearly 100,000 users in 161 countries, paying £6.99 per month.

Natural Cycles was first launched in 2014, in Stockholm and across Sweden.

The company aims to expand the team in the UK and internationally and to continue with more clinical studies and data analysis.

The app can be purchased here.

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[1] http://www.tandfonline.com/doi/full/10.3109/13625187.2016.1154143

ACOG updates the recommendations for use of aromatase inhibitors in gynecology practice.

Aroma-tase is a microsomal cytochrome P450 hemoprotein-containing enzyme with a wide expression in different kind of tissues like ovary, testes, endometrium, brain, breast, placenta, skin, bone, and fat. In these tissues it mediates the conversion of androstenedione to estrone and the conversion of testosterone to estradiol in situ. 

Therefore, for tissues which express this enzyme it creates a hyperestrogenic state leading to proliferation of the tissue.

Based on these varied effects aromatase inhibitors are used in treatment of breast cancer, ovulation induction, endometriosis, and other estrogen-modulated conditions.

Currently three aromatase inhibitors are commercially available. Out of which Exemestane is a steroid-derived aromatase inhibitor that binds irreversibly to aromatase and permanently inactivates the available enzyme while Letrozole and anastrozole are reversible inhibitors of aromatase competing with androgens for aromatase binding sites.

The American College of Obstetricians and Gynecologists supports the following recommendations and conclusions: They were published in June issue of Journal of obstetrics and gynecology.

• For women with breast cancer, bone mineral density screening is recommended with long-term aromatase inhibitor use because of risk of osteoporosis due to estrogen deficiency.
• Based on long-term adverse effects and safety data, when compared with tamoxifen, aromatase inhibitors are associated with a reduced incidence of thrombosis, endometrial cancer, and vaginal bleeding.
• For women with polycystic ovary syndrome and a body mass index (BMI) greater than 30, letrozole should be considered as first-line therapy for ovulation induction because of the increased live birth rate compared with clomiphene citrate. Lifestyle changes that result in weight loss should be strongly encouraged.
• For women with unexplained infertility (regular menstrual cycles, all known male or female factors excluded), a large multicenter study demonstrated that ovulation induction with letrozole resulted in lower live birth rates and multiple gestation rates compared with gonadotropins; however, live birth and multiple gestation rates did not differ significantly between ovulation induction with letrozole compared with clomiphene citrate.
• Aromatase inhibitors are a promising therapeutic option that may help manage endometriosis-associated pain in combination therapy with progestins.

References:

http://journals.lww.com/greenjournal/Fulltext/2016/06000/Committee_Opinion_No__663_Summary___Aromatase.38.aspx#

http://www.acog.org/Resources-And-Publications/Committee-Opinions/Committee-on-Gynecologic-Practice/Aromatase-Inhibitors-in-Gynecologic-Practice

Endocrine Disruptors linked to Endometriosis, Fibroids and rising healthcare costs!

 European Union data revealed that Women are facing a potential risk of several reproductive disorders being exposed common chemicals in the household and incurring huge public health cost.

Endocrine-disrupting compounds (EDCs) act as covert bombers of environmental toxins on human body. They are ubiquitous in our environment, entering our bodies without our knowledge-plastic linings in cans, water bottles, toys and most recently in the thermal paper used in cash register and gas pump receipts.

The recent study led by Patricia Hunt, PhD, at Washington State University was published online March 22, 2016 in the Journal of Clinical Endocrinology & Metabolism. The researchers found that exposure to controversial chemicals, like phthalates and diphenyldichlorethene (DDE), increase a woman’s likelihood of developing endometriosis and fibroids, causing reproductive health problems and incurring a whopping sum of  estimated €1.4 billion ($1.5 billion) a year in health care expenditures and lost earning potential to European Union.

Senior author Leonardo Trasande, MD, MPP, associate professor of pediatrics, environmental medicine & population health at NYU Langone Medical Center, New York, opines that this is just the tip of the iceberg of the entire female reproductive disease burden due to EDC.

Hunt and her colleagues identified other chemicals namely dioxins and polychlorinated biphenyls (PCBs), among others -- but decided to focus on phthalates and diphenyldichlorethene (DDE) as most robust set of data existed for these chemicals. 

DDE is a breakdown product of the insecticide DDT that, although banned in the United States in 1972 and in Europe starting in the 1970s still lingers in the environment and enters our body through food. The main exposure to phthalates is through eating food and drink stored in plastic containers that have phthalates.

In both cases, the epidemiological evidence was low and toxicological evidence was moderate but of all the total cases 20%–39% cases were attributed to these chemicals.

The researchers determined that 145,000 cases of endometriosis among women aged 20 to 44 years and 56,700 cases of uterine fibroids in Europe could be attributed to exposure to endocrine-disrupting chemicals.

In women 15-54 of age, the exposure to DDE was measured in 12 studies by taking a sample of cord blood. They then adapted an Intergovernmental Panel on Climate Change (IPCC) model for determining the probability of causation. The women were separated into groups according to degree of exposure, with the lowest level used as the base and than the odds ratio for developing fibroid was calculated.

The process for phthalate attributable endometriosis was similar, but the investigators relied on data from a large biomonitoring study called as DEMOnstration of a study to COordinate and Perform Human biomonitoring on a European Scale (DEMOCOPHES). Human biomonitoring (HBM) involves collecting samples from human volunteers – blood, hair, saliva or urine – and measuring the levels of indicators of chemicals uptake (known as biomarkers) that are of interest.

The authors further added that "Although it is highly appropriate to focus on these extremely important uterine tract health deficits, [polycystic ovary syndrome], infertility, and pregnancy complications also affect a considerable number of women, have major cost implications, and are increasingly linked to EDC exposures." For instance, phthalate exposure has a 40% to 69% likelihood of causing 618,000 additional assisted reproductive technology procedures each year, and a 20% to 69% likelihood of causing 42,400 new cases of childhood obesity each year.

The director of the National Institute of Environmental Health Sciences and the National Toxicology Program Linda S. Birnbaum said “Some of these chemicals, including PCBs and dioxins, have already been restricted through a treaty called the Stockholm Convention on Persistent Organic Pollutants, which went into effect in 2004.”

The current study is important because it focused on chemicals that have not been restricted, and in the case of DDE -- which persists in the environment -- are not able to be restricted.

"This study is kind of a wake-up to say endocrine disruptors impact the female reproductive system, and we have some evidence they are associated with an increase in endometriosis and fibroids and it costs a lot of money," Birnbaum said.

Not all researchers are convinced by the methodology. They say that to imply causation based on current data is highly speculative because most of the data is based on observational study and trials is human are hard to do.

Even with all the questions that remain, and few regulations in place, "there are safe and simple steps that families and women can take to reduce exposure to endocrine-disrupting chemicals," Trasande said.

"They can eat organic, reduce canned food consumption, which reduces exposure to BPA, and avoid packaged or highly processed food, which is a major route for phthalates to enter food. They can also open windows to allow chemical dust, which accumulates on the carpet and electronics, to circulate out of homes."

Although the study had several limitations: it focused on adult EDC exposure only; it relies on assumption of causation; and it focuses only on two reproductive disorders and two EDCs, it does draws attention on urgent need of  further research , government regulations and public awareness on the issue of toxic chemicals in the environment.

References:

http://press.endocrine.org/doi/10.1210/jc.2015-2873

http://saferchemicals.org/health-report/chemicals-and-our-health/reproduction/

http://www.aboutlawsuits.com/endocrine-disruptor-women-study-97423/

http://www.medpagetoday.com/OBGYN/GeneralOBGYN/56864

http://www.eu-hbm.info/democophes

http://www.thedoctorwillseeyounow.com/content/womens_health/art4602.html

https://www.endocrine.org/news-room/current-press-releases/womens-health-endocrine-disruptors-diabetes-research-will-be-in-spotlight-at-endo-2016