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Validation of Effectiveness on NaturalCycles Users

NCT07566793 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 2000

Last updated 2026-05-08

No results posted yet for this study

Summary

The goal of this observational study is to measure the effectiveness of the Natural Cycles digital birth control application at preventing pregnancy in sexually active women aged 18 to 35 with no known history of infertility. The main questions it aims to answer are:

* What is the pregnancy rate of the application over one year, for all users?
* What is the pregnancy rate of the application over one year, for users who follow the application's instructions perfectly?

Participants will:

* Use the Natural Cycles application for birth control for up to one year.
* Log information about daily sexual activity in the app.
* Complete a questionnaire at the beginning and end of their participation.
* Perform urine pregnancy tests (provided by mail) upon entry to the study, at the start of every cycle during the study, and upon exit from the study.

Conditions

  • Contraception

Interventions

BEHAVIORAL

Log daily intercourse information

For the duration of their participation in the study, participants will use the contraceptive app as usual but will be prompted to diligently log daily intercourse information and to regularly test for pregnancy. Upon exiting the study for any reason, all participants will complete a urine pregnancy test and an online Exit Questionnaire.

DEVICE

Natural Cycles application

Users will receive daily fertility status from Natural Cycles application

Sponsors & Collaborators

  • Natural Cycles

    lead INDUSTRY

Principal Investigators

  • Eleonora Benhar, PhD · Natural Cycles Nordic AB

  • Kristina Gemzell-Danielsson, PhD · Karolinska Institutet

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-28
Primary Completion
2027-12-31
Completion
2027-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07566793 on ClinicalTrials.gov