Menstrual Cycle Symptom Tracking | NCT04756739

Studies
Menstrual Cycle Symptom Tracking

NCT04756739

Sponsor

SPD Development Company Limited

Status

Completed

Last Update Posted

Jan 12, 2022Actual

Enrollment

104Actual

Phase

Not provided

Conditions

Menstrual Cycles

Interventions

Clearblue Connected Ovulation Test System

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 22, 2021Actual

Primary Completion Date

Sep 10, 2021Actual

Completion Date

Sep 10, 2021Actual

First Submitted Date

Feb 11, 2021

First Submission Date that Met QC Criteria

Feb 11, 2021

First Posted Date

Feb 16, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 11, 2022

Last Update Posted Date

Jan 12, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

104Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Clearblue Connected Ovulation Test System	Device	Clearblue Connected Ovulation Test System which is a CE marked device used for tracking the menstrual cycle

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Female only

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Healthy, female volunteers

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sarah Johnson, PhD	SPD Development Company	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
SPD Development Company Ltd		Bedford	Bedfordshire	MK44 3UP	United Kingdom

IPD Sharing Statement Module

Plan to Share IPD

Description

No plan to share IPD

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided