Menstrual Cycle Symptom Tracking

NCT ID: NCT04756739

Last Updated: 2022-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

104 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-22

Study Completion Date

2021-09-10

Brief Summary

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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

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Conditions

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Menstrual Cycles

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Clearblue Connected Ovulation Test System

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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SPD Development Company Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sarah Johnson, PhD

Role: STUDY_DIRECTOR

SPD Development Company

Locations

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SPD Development Company Ltd

Bedford, Bedfordshire, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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PROTOCOL-1276

Identifier Type: -

Identifier Source: org_study_id

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