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NCT07606326

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

Sponsor: IRCCS San Raffaele

View on ClinicalTrials.gov

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.

Key Details

Gender

FEMALE

Age Range

18 Years - 65 Years

Study Type

OBSERVATIONAL

Enrollment

5000

Start Date

2026-06

Completion Date

2040-12

Last Updated

2026-05-26

Healthy Volunteers

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)

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.

Clinical Research Directory

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

Summary

Key Details

Conditions

Eligibility Criteria