Validation of Effectiveness on NaturalCycles Users

Part of paid clinical trials in New York, New York.

Sponsor
Natural Cycles
Study ID
NCT07566793
Status
Recruiting
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Conditions

  • Contraception

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 35 Years
Healthy Volunteers
Not accepted

Interventions

  • Log daily intercourse information — BEHAVIORAL
    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.
  • Natural Cycles application — DEVICE
    Users will receive daily fertility status from Natural Cycles application

Study Details

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.

Key Dates

Start date
Apr 28, 2025
Status verified
May 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
2,000 participants (estimated)

Arms

  • Arm: NC° Users Participating in Study
    An individual who has recently registered to the Natural Cycles app will be screened based on the information routinely collected at registration and invited to the study if they meet specific screening criteria. After informed consent, the onboarding survey will explicitly verify further inclusion and exclusion criteria with participants.

Primary Outcome Measure

13-Cycles Cumulative Contraceptive Failure Rate [ Time Frame: 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Natural Cycles USA CorpNew YorkNew York10036
Megan Callanan
[email protected]
201-431-6036

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By research site
Natural Cycles USA Corp· New York, NY

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