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A Retrospective and Prospective Clinical Registry for Data Collection of Perimenopausal, Menopausal and Premature Ovarian Insufficiency Women

NCT07606326 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 5000

Last updated 2026-05-26

No results posted yet for this study

Summary

This study is designed as on observational, retrospective, and prospective clinical registry aimed at collecting comprehensive real-world data on women in perimenopause, menopause, and with premature ovarian insufficiency (POI) attending a specialized Menopause Clinic and a Multidisciplinary Outpatient Clinic dedicated to Endocrinology and Metabolic Disorders.

The registry comprises both retrospective data, extracted from the medical records of eligible patients evaluated from January 2000 onward, and prospective data, which will be continuously collected for all newly referred patients up to 2040. This combined design allows the longitudinal observation of clinical characteristics, management strategies, and health outcomes across different stages of the menopausal transition and premature ovarian insufficiency within routine clinical practice.

Clinical management and therapeutic strategies, including hormone replacement therapy and non-hormonal interventions, will be documented. Laboratory data, as well as imaging data routinely used in clinical practice, will be recorded when available.

Enrolled patients will undergo a personalized follow-up schedule based on clinical findings and the conclusions of each visit, in accordance with standard clinical practice. Follow-up visits may be scheduled annually for routine monitoring or at shorter intervals (semi-annual or quarterly) in the presence of conditions requiring closer clinical surveillance.

The registry is intended to reflect real-world clinical practice and to support the descriptive evaluation of patterns of care, symptom burden, and longitudinal clinical outcomes in women undergoing the menopausal transition or affected by premature ovarian insufficiency. The collected data will provide a structured platform for epidemiological analyses and hypothesis-generating observational research aimed at improving the understanding and management of menopausal health and associated endocrine and metabolic conditions.

Conditions

  • Menopause
  • Menopausal Hormone Therapy
  • Menopause Surgical
  • Menopause Related Conditions
  • Menopausal Complaints
  • Menopausal Osteoporosis
  • Menopause-related Hot Flashes
  • Menopausal and Perimenopausal Disorder, Unspecified
  • Menopausal and Postmenopausal Women
  • Premature Ovarian Failure (POF)

Sponsors & Collaborators

  • IRCCS San Raffaele

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2040-12-31
Completion
2040-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07606326 on ClinicalTrials.gov