Validation of Effectiveness on NaturalCycles Users
ConditionContraception
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-35
SponsorNatural Cycles
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Wants to avoid pregnancy for 13 cycles.
Is willing to rely solely on Natural Cycles as their sole contraception method for 13 cycles.
Is not currently using permanent contraceptive methods, such as sterilization (of either the user or their partner), or hormonal methods, such as the hormonal contraceptive implant or IUD.
Has an intact uterus, both ovaries and both fallopian tubes to the best of their knowledge.
Disqualifiers
Has EU-citizenship
Has had a Depo-Provera injection in the last 10 months or has had less than three consecutive, spontaneous menstrual cycles since their last injection.
Has had less than three consecutive, spontaneous menstrual cycles after removing a hormonal implant.
Has had less than three consecutive, spontaneous menstrual cycles after the end of a pregnancy.
Trial population
New Natural Cycles application users living in the United States
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Log daily intercourse information
BehavioralFor 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
DeviceUsers will receive daily fertility status from Natural Cycles application
Treatment groups
2,000 Participants
are divided into 1 treatment groupGroup A: NC° Users Participating in Study2 interventions
Trial outcomes
Primary outcomes
1
13-Cycles Cumulative Contraceptive Failure Rate
The cumulative contraceptive failure rate in Typical Use and Perfect Use will be calculated using Kaplan-Meier survival analysis. This represents the probability of becoming pregnant within the first year of typical or perfect use of the Natural Cycles app. A confirmed pregnancy, identified through a positive urine pregnancy test, will be considered an event.
Time frame
1 yearSecondary outcomes
1
Pearl Index (PI)
The traditional Pearl Index (number of pregnancies per 100 woman-years of exposure) for Typical Use and Perfect Use. This will allow for comparison with historical contraceptive studies.
Time frame
1 year2
One-year study continuation rate
The rate at which participants continue their active involvement in the research study, calculated using Kaplan-Meier survival analysis. Discontinuation from the study for any reason is an event.
Time frame
1 year3
One-year product continuation rate
The rate at which participants continue using the Natural Cycles app as their primary contraceptive method, independent of study exit, calculated using Kaplan-Meier survival analysis. Discontinuation of product use as contraception (e.g., switching to "Plan Pregnancy" mode, becoming inactive in the app) is an event.
Time frame
1 year4
Participant satisfaction ratings
Assessment of participants' satisfaction with the Natural Cycles Birth Control method, collected through an online Exit Questionnaire. This includes qualitative feedback on user experience.
Time frame
At study exit, at most 1 year after entry to study.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov