Menstrual Cycle Symptom Tracking

Menstrual Cycles Clinical Trial

Official title:

Menstrual Cycle Symptom Tracking Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04756739
• Other study ID #: PROTOCOL-1276
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Menstrual Cycles

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