World’s first contraception app as effective as condom approved
A contraception app that uses body temperature to track a woman’s menstrual cycle has been given the seal of approval.In a clinical study of 4,000 women in 2016, it was claimed to be as effective as the contraceptive pill. Now, German-based regulator Tuv Sud has approved it as a Class IIb medical device – the same level as acupuncture needles and blood bags.
The app is believed to be the first software of its kind to be certified as a contraception alongside condoms, the pill and intrauterine devices (IUDs).
Dr. Elina Berglund, who created the app with her husband Dr Raoul Scherwitzl, said: “Women around the world are interested in exploring effective non-hormonal, non-invasive forms of contraception.
“And now they have a new, clinically verified and regulatory approved option to choose from.”A growing number of wearable devices and software have appeared that focus on female health and fertility, but none have previously been certified as clinically viable.
“Our high quality clinical studies, together with the required regulatory approvals, means we can provide women everywhere with a new option for contraception,” Berglund added.
“Natural Cycles allow women to better understand their bodies so they can make choices that are right for them.”Natural Cycle uses a woman’s temperature to predict the days of the month when she is at her most fertile. On these, red days, the app advises a couple use a condom to reduce the risk of becoming pregnant.
In just three steps, a woman can discover if she is at risk of becoming pregnant. In the days leading up to ovulation, a woman’s body is flooded by oestrogen, which cools the body, compared with the post-ovulatory stage.
During that second stage of the menstrual cycle, after ovulation, the hormone progesterone warms the body, raising its temperature.The two phases are separated by ovulation day – when a woman is at her most fertile – when the body’s temperature rises between 0.2 and 0.45°C.
Currently, uncontrollable mood-swings, spontaneous bouts of crying even a loss of libido are common complaints of the Pill.There have also been associated risks with strokes, with a 2016 study published in the British Medical Journal suggesting that third generation pills raise the chance of a serious blood clot four fold.
But the drugs safety watchdog, the Medicines and Healthcare products Regulatory Agency, said contraceptive pills are ‘very safe, highly effective medicines’ and a review had confirmed the risk of blood clots with all contraceptives is small.
*Adapted from DailyMailUK Online
No Comments yet