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

Collection of Urine Samples From Non-pregnant Peri and Post-menopausal Women

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy

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 If a subject informs the trial site that they have become pregnant prior to urine sample collection, they will be withdrawn from the study and no urine sample will be collected.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 Type: Observational
• Enrollment (Actual): 443

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 41 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Healthy volunteers

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Peri menopausal; Participants aged 41-55 years
post menopausal; participants aged 56-65 years

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: SPD Development Company Limited
• Collaborators: Richmond Pharmacology Limited
• Investigators: Principal Investigator: Jorg Taubel, MD FFPM, Richmond Pharmacology

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2016
• Primary Completion (Actual): March 1, 2017
• Study Completion (Actual): August 1, 2017

Study Registration Dates

• First Submitted: October 25, 2016
• First Submitted That Met QC Criteria: October 25, 2016
• First Posted (Estimate): October 26, 2016

Study Record Updates

• Last Update Posted (Actual): January 8, 2018
• Last Update Submitted That Met QC Criteria: January 4, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Pregnancy
• Other Study ID Numbers: Protocol-0842

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This is a sample collection study only, no research IPD available