NCT04756739

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 11, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 16, 2021

Completed
6 days until next milestone

Study Start

First participant enrolled

February 22, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2021

Completed
Last Updated

January 12, 2022

Status Verified

January 1, 2022

Enrollment Period

7 months

First QC Date

February 11, 2021

Last Update Submit

January 11, 2022

Conditions

Menstrual Cycles

Outcome Measures

Primary Outcomes (1)

  • Menstrual Cycle Symptoms

    The primary objective of this study is to collect information from women on their experience of menstrual cycle symptoms

    3 months

Interventions

Clearblue Connected Ovulation Test SystemDEVICE

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

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale only
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy, female volunteers

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SPD Development Company Ltd

Bedford, Bedfordshire, MK44 3UP, United Kingdom

Location

Study Officials

  • Sarah Johnson, PhD

    SPD Development Company

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2021

First Posted

February 16, 2021

Study Start

February 22, 2021

Primary Completion

September 10, 2021

Study Completion

September 10, 2021

Last Updated

January 12, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

No plan to share IPD

Locations

GB(1)