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
Qualifiers
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 design
Treatments tested in this trial
- Log daily intercourse information
- Natural Cycles application
Treatment groups
2,000 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov