Contraception Clinical Study Results

Contraception Clinical Study Results

Eirini Rapti Eirini Rapti

Clinical study on contraception: inne minilab's effectiveness confirmed

Are you excited?

We are excited!

The entire inne team is proud and happy to announce the successful completion of the clinical study on the effectiveness of the inne Minilab for contraception. The results of the independent study confirm the highest efficacy of the inne Minilab. This marks an important milestone for the inne Minilab, as the first saliva-based hormone and cycle tracker on the German market, to become the leading fem-health device in the field of cycle and hormone tracking.

Inne has set out to provide women around the world with a modern, safe and hormone-free method that enables them to take charge of all aspects of their fertility reliably and in-depth. This includes conception support and cycle tracking as well as contraception. 

A clinical, independently conducted study was commissioned to evaluate the effectiveness of the inne Minilab in preventing pregnancy, with the aim of using the inne Minilab as a natural method of contraception following appropriate certification. 

The study results attest to the inne Minilab 

100 % effectiveness with "perfect use" (Pearl Index 0.0) 
92 % effectiveness with "typical use" (Pearl Index 7.98)

For the inne study, a Pearl Index of 0.0 was achieved with perfect use, but there is a residual risk of pregnancy outside the study setting that cannot be ruled out. No form of contraception is completely effective. With typical use, inne has a Pearl Index of 7.98, which means that 8 out of 100 women who use inne as a contraceptive for one year could become pregnant.

How does inne's effectiveness compare to other methods?

Pill: 99% perfect use, 93% typical use
Condom: 98% perfect use, 87% typical use
Symptothermal method: 98% perfect use, 93% typical use

What does this mean?

The results confirm the effectiveness of inne as a natural contraceptive method in addition to the functions for promoting conception and cycle and hormone tracking.
The next step, which is still pending, is the approval of the documentation of the inne Minilab for the intended use of contraception by the responsible EU certification bodies for medical devices. Inne is confident that the ongoing process can be finalised promptly and positively. 

Key data of the study

The study ran for one year from May 2022. The evaluation report was completed in October 2023. 300 women took part in the study. 1467 cycles were recorded, which corresponds to 112.85 woman-years. The inne Minilab consists of the inne Strip for taking the saliva sample and measuring the hormone (progesterone), the inne Reader and the inne App for analysing and displaying the results.

How are the results to be understood? 

Perfect use" refers to how well a method works under perfect conditions, while "typical use" reflects normal use under real-life conditions. 

For example, "perfect use" of a condom includes putting it on correctly before starting sexual intercourse, making sure it is not past its expiry date and removing it carefully after use. Typical use" includes situations such as putting the condom on incorrectly, tearing it, not wearing it during the entire sexual intercourse or using it after the expiry date. We are human, these things happen.

For background - what does the categorisation of perfect and typical use mean for the inne Minilab? 

For inne to work properly, saliva tests must be performed regularly with our Minilab, especially on the days around ovulation, which we refer to as "important measurement days". If the Minilab is not used correctly and regularly, this is categorised as "typical use" and not "perfect use". In addition, inne highlights the fertile days in colour as "high probability of pregnancy". 

Failure of alternative contraceptives (such as the condom) during these days is recorded under "expected use" but not under "perfect use". If a participant in our clinical trial became pregnant and the date of conception was a day labelled "high probability of pregnancy", then this pregnancy is included in "typical use".

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