Urine Sample Collection From Non Pregnant Peri and Post-menopausal Women

Completed

• Conditions: Pregnancy

• Registration Number: NCT02945189
• Lead Sponsor: SPD Development Company Limited

Brief Summary

This is a sample collection study, participants will be required to collect one (if last menstrual period ≥12 months) or two (if last menstrual period \<12 months) urine samples and return them to the study site, together with collection sample information. Participants having a menstrual cycle within the last 6 months will also be required to provide follow-up information on pregnancy status and date of next menstrual bleed.

Detailed Description

Each subject will be provided with a urine sample collection container, a transport container, barcode labels, prepaid envelopes and a full set of study instructions, together with the materials required to facilitate the collection of a follow-up urine sample and completion of follow up form, where applicable.

Subjects admitted into the study that are unsure of their pregnancy status will be provided with a marketed Clearblue HPT, to test for pregnancy prior to beginning the study. If a subject informs the trial site that they have become pregnant prior to urine sample collection, they will be withdrawn from the study and no urine sample will be collected. The subject will return their materials to the study site, and the co-ordinator will complete the exit form.

Subjects will be required to collect a urine sample, label their sample (as soon as collected) with the appropriate bar-coded label provided and return this to the study site. Where it is not possible to return the sample as soon as collected, urine samples must be stored in a domestic fridge in the container provided for a maximum of 1 week and then sent to the study site at their earliest convenience.

Subjects will receive follow-up to establish pregnancy status unless ≥ 12 months from their last menstrual period (LMP). On completion of the study, subjects will be reimbursed for their participation.

It is anticipated that sample collection will be carried out remotely (i.e. at the volunteers home) but volunteers may attend the study site for sample collection should they require.

Study Timeline

• Study Start: 2016-10
• Study First Submitted: 2016-10-25
• Study First Submitted QC: 2016-10-25
• Study First Posted: 2016-10-26
• Primary Completion: 2017-03
• Study Completion: 2017-08
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-04
• Last Update Posted: 2018-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 443

Inclusion Criteria

• Known to be not pregnant,
• Willing to give consent

Exclusion Criteria

• Pregnant or breastfeeding,
• Pregnant within last 2 months,
• Having treatment for infertility,
• Taken hormonal contraception containing hCG in last month,
• Using hormonal contraception within last month,
• Previously taken part in sample collection study for SDP (providing 1-7 samples).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Individual urine samples obtained from 150 not pregnant women aged 41-55 years and 150 not pregnant women aged 56 - 65 years	2 months	Urine sample collection from healthy volunteers of peri (age 41-55) and post (age 56-65) menopausal women