An observational study in Menopause, Menopausal Hormone Therapy and Menopause Surgical, sponsored by IRCCS San Raffaele. Not yet recruiting. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-05-26.
Sponsored by IRCCS San Raffaele · Observational
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.
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.
334 studies on the registry are indexed under Osteoporosis, Postmenopausal; 28 are open to participants now.
This study's planned enrollment of 5,000 is above the median of 160 across 57 observational studies indexed under Osteoporosis, Postmenopausal.
Browse Osteoporosis, Postmenopausal studies →IRCCS San Raffaele is the lead sponsor of 453 studies on the registry; 234 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
Time frame: From 2000 to 2040
No study locations are listed for this record.
Start is estimated for Jun 2026; primary completion for Dec 2040, 174 months later.
Of 23 observational studies under Osteoporosis, Postmenopausal, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 65. This study's planned 174 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Osteoporosis, Postmenopausal →