Extension for Menopause Sample Collection

What this trial studies

This study will provide urine samples from women going through the menopause transition in order to maintain the SPD sample bank. Symptom information and cycle length will also be recorded to observe how these change through the menopause transition.

Conditions in scope

• Menopause

Interventions

• Not specified in the public record.

Who can join

Women only · Ages 18 Years and up · Accepts healthy volunteers.

Inclusion criteria

• Pre- and peri-menopausal volunteers(assigned by STRAW+10 criteria) who completed PROTOCOL-1326

Exclusion criteria

• Post-menopausal volunteers (12 months since last menstrual period)
• Use of hormone replacement therapy (HRT)
• Use of hormone contraception
• Hysterectomy and/or oophorectomy
• Pregnant or breast feeding
• Other medical reason for amenorrhea (absence of menstruation)

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Completed
• Study type: Observational
• Phase: N/A
• Start date: 2024-01-22
• Primary completion: 2025-05-07
• Last update posted: 2025-05-13
• First posted: 2023-12-14

Sponsor & contact

Lead sponsor: SPD Development Company Limited (Industry)

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Number of Urine Samples Collected (Daily samples for 10 days at 0, 6 and 12 months)
  Daily Urine Samples

Related ClearedRx care

If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.