NCT04008277

Brief Summary

In this study, women will be required to wear a heart rate monitor continuously and collect daily early morning urine samples for the duration of one complete menstrual cycle. This will enable comparisons between data collected from the heart rate monitor and hormone analysis in urine samples to be made.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2019

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

July 2, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 5, 2019

Completed
14 days until next milestone

Study Start

First participant enrolled

July 19, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 2, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

February 20, 2020

Status Verified

February 1, 2020

Enrollment Period

3 months

First QC Date

July 2, 2019

Last Update Submit

February 19, 2020

Conditions

Ovulation

Outcome Measures

Primary Outcomes (2)

  • Heart Rate

    Heart rate at time points throughout the menstrual cycle

    1 month

  • Heart Rate Variability

    Heart rate variability at time points throughout the menstrual cycle

    1 month

Secondary Outcomes (3)

  • Day of ovulation

    1 month

  • Fertile window

    1 month

  • Fertile window closure

    1 month

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy volunteers

You may qualify if:

  • Age 18 years and over
  • Regular menstrual cycles

You may not qualify if:

  • Taking any hormonal medications
  • Taking any medications that may affect heart rate
  • Known heart condition or use of a pacemaker
  • Skin condition where there is sensitivity to wearing a skin monitor
  • Currently suffering with anxiety or panic attacks
  • Pregnant or breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SPD Development Company Ltd.

Bedford, Bedfordshire, MK44 3UP, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Daily urine samples collected

Study Officials

  • Sarah Johnson

    SPD Development company Ltd.

    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

July 2, 2019

First Posted

July 5, 2019

Study Start

July 19, 2019

Primary Completion

October 2, 2019

Study Completion

December 31, 2019

Last Updated

February 20, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)