Menstrual Cycle Symptom Tracking

Menstrual Cycle Symptom Tracking Study

This study will provide menstrual cycle symptom information from women over the course of three menstrual cycles to determine whether there are any noticeable physiological changes that can be related to stage of the menstrual cycle or onset of menstruation.

Study Overview

• Status: Completed
• Conditions: Menstrual Cycles
• Intervention / Treatment: Device: Clearblue Connected Ovulation Test System

• Study Type: Observational
• Enrollment (Actual): 104

Contacts and Locations

Study Locations

• United Kingdom
  • Bedfordshire
    • Bedford, Bedfordshire, United Kingdom, MK44 3UP
      • SPD Development Company Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Healthy, female volunteers

Description

Inclusion Criteria:

• Female
• Aged 18 years and over
• Regular menstrual cycles
• Owns a compatible smart phone i.e. iPhones® and AndroidTM phones equipped with Bluetooth® 4.0/BLE
• Willing to use their own smartphone for the duration of this study and to download and install the study app
• Willing to give informed consent

Exclusion Criteria:

• Currently trying to conceive
• Currently or recently pregnant or breastfeeding
• Taking any treatment which may affect the menstrual cycle (e.g. contraceptive pill, fertility medications or hormone replacement therapy)
• Taking or undergoing any other medical treatment for fertility such as ovulation drugs, artificial insemination and assisted fertility such as In vitro fertilization (IVF) or Intracytoplasmic sperm injection (ICSI)
• Has abnormal liver or kidney function
• Taking antibiotics containing tetracycline
• Taking clomiphene citrate or other ovulation induction drugs

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Menstrual Cycle Symptoms	The primary objective of this study is to collect information from women on their experience of menstrual cycle symptoms	3 months

Collaborators and Investigators

• Sponsor: SPD Development Company Limited
• Investigators: Study Director: Sarah Johnson, PhD, SPD Development Company

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2021
• Primary Completion (Actual): September 10, 2021
• Study Completion (Actual): September 10, 2021

Study Registration Dates

• First Submitted: February 11, 2021
• First Submitted That Met QC Criteria: February 11, 2021
• First Posted (Actual): February 16, 2021

Study Record Updates

• Last Update Posted (Actual): January 12, 2022
• Last Update Submitted That Met QC Criteria: January 11, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: PROTOCOL-1276

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: No plan to share IPD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No