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

NCT02945189 | Completed

• 1 other identifier: Protocol-0842
• Study Type: observational
• Target: 443
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pregnancy

Keywords

Pregnancy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Peri menopausal

Participants aged 41-55 years

post menopausal

participants aged 56-65 years

Eligibility Criteria

• Age: 41 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy volunteers

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• SPD Development Company Limited: lead
• Richmond Pharmacology Limited: collaborator

Biospecimen

Retention: SAMPLES WITH DNA

Urine samples collected and stored

Study Officials

• Jorg Taubel, MD FFPM

  Richmond Pharmacology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2016
• First Posted: October 26, 2016
• Study Start: October 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: August 1, 2017
• Last Updated: January 8, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share