Cycle and Ovulation Study Expansion

Menstruation Clinical Trial

Official title:

Cycle and Ovulation Study Expansion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05852951
• Other study ID #: Pro00054031
• Status: Completed
• Start date: June 9, 2021
• Est. completion date: May 23, 2022

Study information

• Verified date: May 2023
• Source: Apple Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The objective of this study was to collect menstrual cycle, health sensor data and general health information to understand correlations between menstrual cycle and health sensor data, and how those correlations may be affected by general health. Participants entered menstrual cycle information (such as start dates, end dates, symptoms, flow), basal body temperature as measured by a thermometer, and ovulation and progesterone test results via apps installed on their iPhone. Additionally, participants were provided with an Apple Watch and a wrist-worn hardware prototype wrist-worn sleep band to collect physiological sensor data. Both menstrual cycle information and physiological sensor data stored on the participants' iPhone prior to enrolling in the study (up to 18 months) was also collected. This study aimed to collect data from females aged 14 and older who are currently menstruating with irregular and regular menstrual cycles.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 698
• Est. completion date: May 23, 2022
• Est. primary completion date: May 23, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 14 Years and older

Eligibility

• At least 14 years of age (19 for residents of Alabama and Nebraska and 21 for residents of Mississippi)

• Can communicate in written and spoken English

• Own functioning iPhone iOS 14 or later, with access to reliable data plan and Wifi

• Access to reliable Wifi in the bedroom

• Willingness to participate in remote visits and follow study procedures for the duration of the study, including use of Apple Watch and a wrist-work hardware prototype

• Able to read and understand the written consent form

• Reside in the US for the duration of the study

Related Conditions & MeSH terms

• Menstruation

Locations

Country	Name	City	State
United States	Exponent	Phoenix	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Apple Inc.	Exponent

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retrospective ovulation day estimate	Retrospective ovulation day estimation (algorithm uses multiple measurements including menstrual flow, urine ovulation prediction testing, basal body temperature, overnight aggregated wrist temperature)	12 months