Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
151 participants
OBSERVATIONAL
2021-04-19
2023-03-01
Brief Summary
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Urine samples will be received in the clinical laboratory and aliquoted into 2.25ml amounts and stored at -80˚C until required.
Symptom information will also be recorded to determine whether there are any noticeable physiological changes that can be related to stage of the menopause.
Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Early Stage Peri-Menopause
Mild cycle irregularity over the last 3-6months (minimum), variation of \>6 days in length between consecutive cycles including shortened and longer cycles (but not \>60 days in length)
No interventions assigned to this group
Late Stage Peri-Menopause
Late stage peri-menopause: Irregular cycles with prolonged periods of amenorrhea \>60 days in length (but less than 12 months)
No interventions assigned to this group
Post-Menopause
Greater than 12 months since last menstrual period
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Between the ages of 45 and 60 years
* Suspects they are going through or have been through the menopause
* Experiencing cycle irregularities:
* Early Stage Peri-Menopause: Mild cycle irregularity over the last 3-6months (minimum), variation of \>6 days in length between consecutive cycles including shortened and longer cycles (but not \>60 days in length)
* Late stage peri-menopause: Irregular cycles with prolonged periods of amenorrhea \>60 days in length (but less than 12 months)
* Post-Menopause: Greater than 12 months since last menstrual period
* Willing to give informed consent
Exclusion Criteria
* Use of hormone contraception
* Hysterectomy and/or oophorectomy
* Pregnant or breast feeding
* Other medical reason for amenorrhea (absence of menstruation)
45 Years
60 Years
FEMALE
Yes
Sponsors
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SPD Development Company Limited
INDUSTRY
Responsible Party
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Principal Investigators
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Raniero Zazzeroni
Role: STUDY_DIRECTOR
SPD Development Company
Jackie Boxer
Role: PRINCIPAL_INVESTIGATOR
SPD Development Company
Locations
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SPD Development Company Ltd
Bedford, Bedfordshire, United Kingdom
Countries
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Other Identifiers
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PROTOCOL-1326
Identifier Type: -
Identifier Source: org_study_id