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

May 19, 2026 updated by: Stefano Salvatore, IRCCS San Raffaele

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.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

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. Only visits performed within these dedicated ci outpatient settings will be included in the registry.

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.

Data collected within the registry include demographic characteristics, general and gynecological medical history, reproductive history, lifestyle factors, and comorbidities. Menopause-related symptoms reported by the patients will be systematically recorded, and validated questionnaires may be administered when clinically indicated to provide an objective assessment of symptom severity and impact on quality of lite, including Female Sexual Function lndex (FSFI), Visual Analogue Scale (VAS), Vaginal Health lndex (VHI), and the Day to Day lmpact of Vaginal Aging (DIVA).

Clinical management and therapeutic strategies, including hormone replacement therapy and non-hormonal interventions, will be documented. Laboratory data, encompassing hormonal, metabolic, and biochemical parameters, as well as imaging data routinely used in clinical practice, will be recorded when available. lmaging assessments include dual-energy X-ray absorptiometry (DEXA) for bone health evaluation, transthoracic echocardiography and carotid Doppler ultrasound tor cardiovascular risk assessment, and transvaginal pelvic ultrasound for gynecological evaluation.

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.

Study Type

Observational

Enrollment (Estimated)

5000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population consists of women attending a specialized Menopause Clinic and a Multidisciplinary Outpatient Clinic dedicated to Endocrinology and Metabolic Disorders who meet the diagnostic criteria or perimenopause, menopause, early menopause, or premature ovarian insufficiency, as defined by the standardized international reference STRAW +10 (Stages of Reproductive Aging Workshop).

Description

Inclusion Criteria:

  • 1. Age: women aged 18-60 years at the time of enrollment and in follow up, up to 65 years old
  • 2. Women in Perimenopause, defined as the transitional period preceding the final menstrual period, characterized by changes in menstrual cycle regularity and/or the onset of menopausal symptoms. Women experience variable cycle length, skipped cycles, or amenorrhea of less than 12 months' duration, often accompanied by vasomotor symptoms, sleep disturbances, and other menopause-related complaints.
  • 3. Women in Menopause, defined as the permanent cessation of menstruation resulting from loss of ovarian follicular activity and is diagnosed retrospectively after 12 consecutive months of amenorrhea in the absence of other pathological or physiological causes. Women may present with persistent menopausal symptoms and/or long-term consequences of estrogen deficiency, including changes in bone, cardiovascular, metabolic, and genitourinary health.

lt includes women in early Menopause, defined as menopause occurring before the age of 45 years, but after 40 years, in the absence of surgical or iatrogenic causes.

  • 4. Women in Premature Ovarian lnsufficiency (POI), defined as impaired ovarian function occurring before the age of 40 years, characterized by oligo- or amenorrhea, elevated gonadotropin levels, and hypoestrogenism.
  • 5. Women with iatrogenic menopause, caused by:
  • Bilateral oophorectomy
  • Chemotherapy or radiotherapy-induced ovarian failure
  • Other pharmacological treatments resulting in ovarian insuftficiency
  • 6. Women evaluated at the specialized Menopause Clinic or the Multidisciplinary Endocrinology/Metabolic Disorders clinic.
  • 7. Data availability: for retrospective participants, sufficient medical records must be available; tor prospective participants, patients must be willing to participate in the registry and provide informed consent.
  • 8. All women are eligible regardless of concomitant diseases, to reflect real-world clinical practice.

Exclusion Criteria:

  • 1. Women unable to provide informed consent due to cognitive impairment or severe psychiatric conditions.
  • 2. Women already participating in interventional clinical trials affecting menopausal or metabolic management in a way that could bias observational data.
  • 3. Women with incomplete medical records for retrospective data collection or those refusing informed consent for prospective enrollment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
The primary objective of this study is to establish a 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 attending a specialized Menopause Clinic and a multidisciplinary outpatient clinic dedicated to Endocrinology and Metabolic Disorders. The registry aims to support clinical monitoring, epidemiological description, and the characterization of real-world patterns of care and management strategies in women undergoing the menopausal transition or affected by premature ovarian insufficiency, within routine clinical practice.
From 2000 to 2040

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS San Raffaele

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

December 1, 2040

Study Completion (Estimated)

December 1, 2040

Study Registration Dates

First Submitted

May 19, 2026

First Submitted That Met QC Criteria

May 19, 2026

First Posted (Actual)

May 26, 2026

Study Record Updates

Last Update Posted (Actual)

May 26, 2026

Last Update Submitted That Met QC Criteria

May 19, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UNIVERSO MENOPAUSA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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