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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04756739
Other study ID # PROTOCOL-1276
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 22, 2021
Est. completion date September 10, 2021

Study information

Verified date January 2022
Source SPD Development Company Limited
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 104
Est. completion date September 10, 2021
Est. primary completion date September 10, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
Clearblue Connected Ovulation Test System
Clearblue Connected Ovulation Test System which is a CE marked device used for tracking the menstrual cycle

Locations

Country Name City State
United Kingdom SPD Development Company Ltd Bedford Bedfordshire

Sponsors (1)

Lead Sponsor Collaborator
SPD Development Company Limited

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Menstrual Cycle Symptoms The primary objective of this study is to collect information from women on their experience of menstrual cycle symptoms 3 months
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04595760 - Factors Influencing Fertility or Pregnancy Health
Completed NCT05091658 - Period Tracker Lay User Study
Completed NCT05088382 - Period Tracker at Home Study