PregnancyNCT02945189
Urine Sample Collection From Non Pregnant Peri and Post-menopausal Women
An observational study of Pregnancy, run by SPD Development Company Limited.
Trial 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. Read more about this study
- Who is it for?
- Ages 41 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- How many people
- 443 participants
- Where
- No sites listed yet
- Study dates
- Oct 2016to Aug 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 41 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy volunteers
Who may be able to join
- Known to be not pregnant,
- Willing to give consent
Who cannot join
- 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).
About this study
Official title: 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.
Read the 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.
- Conditions
- Pregnancy
- Keywords
- Pregnancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Peri menopausal | Participants aged 41-55 years | |
| post menopausal | participants aged 56-65 years |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionMar 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 443 participants (actual)
Sponsor and investigators
- Lead sponsor
- SPD Development Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Richmond Pharmacology Limited
- Responsible party
- Sponsor
- Investigators
- Jorg Taubel, MD FFPM, Principal investigator, Richmond Pharmacology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02945189
- Sponsor's protocol ID
- Protocol-0842
- Status last verified
- Jan 2018
- First submitted
- 25 Oct 2016
- Last updated
- 8 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: This is a sample collection study only, no research IPD available
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collection of Urine Samples From Non-pregnant Peri and Post-menopausal Women
- ClinicalTrials.gov ID
- NCT02945189
- Acronym / sponsor ID
- Protocol-0842
- Conditions
- Pregnancy
- Keywords
- Pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 443 participants (actual)
- Lead sponsor
- SPD Development Company LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Richmond Pharmacology Limited
- Study start
- Oct 2016 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 26 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peri menopausal | – | –Participants aged 41-55 years |
| post menopausal | – | –participants aged 56-65 years |
Who may qualify
- Ages
- 41 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteers
Key inclusion criteria (2 listed)
- Known to be not pregnant,
- Willing to give consent
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Individual urine samples obtained from 150 not pregnant women aged 41-55 years and 150 not pregnant women aged 56 - 65 years
Time frame: 2 months
Urine sample collection from healthy volunteers of peri (age 41-55) and post (age 56-65) menopausal women
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2018.
- Individual participant dataSharing planned: No. This is a sample collection study only, no research IPD available
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jorg Taubel, MD FFPM principal investigator
Richmond Pharmacology
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy, run by SPD Development Company Limited.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Individual urine samples obtained from 150 not pregnant women aged 41-55 years and 150 not pregnant women aged 56 - 65 years (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2018.