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

Обзор

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.

Подробное описание

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.

Первичные конечные точки

• 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 [Срок оценки: From 2000 to 2040]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

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• Lobo RA, Gompel A. Management of menopause: a view towards prevention. Lancet Diabetes Endocrinol. 2022 Jun;10(6):457-470. doi: 10.1016/S2213-8587(21)00269-2. Epub 2022 May 5. PMID 35526556
• Management of osteoporosis in postmenopausal women: the 2021 position statement of The North American Menopause Society. Menopause. 2021 Sep 1;28(9):973-997. doi: 10.1097/GME.0000000000001831. PMID 34448749
• Lumsden MA, Davies M, Sarri G; Guideline Development Group for Menopause: Diagnosis and Management (NICE Clinical Guideline No. 23). Diagnosis and Management of Menopause: The National Institute of Health and Care Excellence (NICE) Guideline. JAMA Intern Med. 2016 Aug 1;176(8):1205-6. doi: 10.1001/jamainternmed.2016.2761. No abstract available. PMID 27322881
• Avis NE, Crawford SL, Greendale G, Bromberger JT, Everson-Rose SA, Gold EB, Hess R, Joffe H, Kravitz HM, Tepper PG, Thurston RC; Study of Women's Health Across the Nation. Duration of menopausal vasomotor symptoms over the menopause transition. JAMA Intern Med. 2015 Apr;175(4):531-9. doi: 10.1001/jamainternmed.2014.8063. PMID 25686030
• Gracia CR, Freeman EW. Onset of the Menopause Transition: The Earliest Signs and Symptoms. Obstet Gynecol Clin North Am. 2018 Dec;45(4):585-597. doi: 10.1016/j.ogc.2018.07.002. Epub 2018 Oct 25. PMID 30401544
• Hickey M, Szabo RA, Hunter MS. Non-hormonal treatments for menopausal symptoms. BMJ. 2017 Nov 23;359:j5101. doi: 10.1136/bmj.j5101. No abstract available. PMID 29170264
• Jaffe JH, Kanzler MB. Tobacco and nicotine self-administration in humans: the evolution of a methodology. NIDA Res Monogr. 1978 Jul;(20):209-20. No abstract available. PMID 101855

Идентификаторы

NCT: NCT07606326 · UNIVERSO MENOPAUSA

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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