Clearblue Advanced Fertility Monitor Consumer One Cycle at Home Study

NCT01948258 | Completed Results

• 1 other identifier: 0481
• Study Type: interventional
• Target: 395
• Locations: 1 country
• Sites: 1

Brief Summary

This study will assess the use of the new Clearblue Advanced Fertility Monitor for one menstrual cycle in a home setting by female volunteers seeking to get pregnant.

Conditions

Pregnancy

Keywords

Pregnancy

Outcome Measures

Primary Outcomes (1)

• The Ability of the Volunteer to Use the New Clearblue Advanced Fertility Monitoring a Home Setting

  Acceptance criteria is that ≥80% of volunteers will score 3 or less on the Likert scale in a home setting by demonstrating ease of use and comprehension of the instructions for use.

  one month use

Secondary Outcomes (1)

• Correct Identification of Monitor Status

  one month

Other Outcomes (1)

• Pregnancy Test Result

  one month

Study Arms (1)

Clearblue Advanced Fertility Monitor

OTHER

Use of Clearblue Fertility Monitor

Device: Clearblue Advanced Fertility Monitor

Interventions

Clearblue Advanced Fertility Monitor DEVICE

Clearblue Advanced Fertility Monitor used for one menstrual cycle in a home setting

Clearblue Advanced Fertility Monitor

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Female
• Aged 18 - 45 years
• Willing to provide written informed consent to participate in the study and comply to the investigational procedures
• Naive to similar marketed products including current Clearblue fertility monitor and Persona
• Two natural cycles immediately prior to entering the study, each lasting between 21 and 42 days
• Seeking to become pregnant

You may not qualify if:

• Unwilling to provide written informed consent to participate in the study or comply with study procedures
• Employees of SPD, Proctor \& Gamble or Alere
• Have a condition that is known to be contra-indicated in pregnancy
• Usually have menstrual cycles which are shorter than 21 days or longer than 42 days
• Using or have used in their last 2 cycles, hormonal contraceptives including oral, emergency oral, implants, patches, transdermal injections, vaginal ring and progesterone intrauterine systems (IUS)
• Using or have used in the last 2 cycles, infertility medications or hormone replacement therapy containing hCG or LH
• Taking clomiphene citrate or other ovulation induction drugs
• Are using any treatment which may affect the menstrual cycle
• Have recently been pregnant, miscarried or breastfeeding
• Have been diagnosed with polycystic ovarian syndrome (PCOS)
• Are peri- or post-menopausal e.g. experiencing symptoms such as irregular menstrual periods, hot flushes, night sweats, sleep disturbances and mood swings
• Are taking antibiotics containing tetracyclines
• Have impaired liver or kidney function
• Have previously participated in a SPD 'trying to conceive' study

Sponsors & Collaborators

• SPD Development Company Limited: lead

Study Sites (1)

SPD Development Company Ltd

Bedford, Bedfordshire, MK43 7JX, United Kingdom

Location

Limitations and Caveats

There was some incomplete data with women not using the monitor on all the days that ideally would have been tested. We believe the missing data did not affect the objectives of the study.

Results Point of Contact

• Title: Dr Sarah Johnson, Head of Clinical and Regulatory Affairs
• Organization: SPD Swiss Precision Diagnostics GmbH/SPD Development Company Ltd

sarah.johnson@spdspark.com

01234835486

Study Officials

• Sarah Johnson, PhD

  SPD Swiss Precision Diagnostics GmbH

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2013
• First Posted: September 23, 2013
• Study Start: March 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: November 2, 2018
• Results First Posted: November 2, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)