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

Sponsor
IRCCS San Raffaele
Study ID
NCT07606326
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

First listed
May 26, 2026
Start date
Jun 30, 2026
Status verified
May 2026
Primary completion
Dec 31, 2040
Completion
Dec 31, 2040

Study Design

Enrollment
5,000 participants (estimated)

Primary Outcome Measure

retrospective and prospective clinical registry to systematically collect Demographic, clinical, anamnestic, laboratory, and imaging data in women in perimenopause, menopause, and with premature ovarian insufficiency [ Time Frame: From 2000 to 2040 ]

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