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

NCT07606326 | Not Yet Recruiting

• 1 other identifier: UNIVERSO MENOPAUSA
• Study Type: observational
• Target: 5,000
• Locations: 0 countries
• Sites: N/A

Brief 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.

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)

Keywords

menopause; perimenopause; premature ovarian failure; hormonal replacement teraphy; osteoporosis; genitourinary syndrome of menopause; hot flashes; menopausal discomfort; menopausal symptoms

Outcome Measures

Primary Outcomes (1)

• 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.

  From 2000 to 2040

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: * 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 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. 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. * 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.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• \. Age: women aged 18-60 years at the time of enrollment and in follow up, up to 65 years old
• \. 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.
• \. 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.
• \. 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.
• \. Women with iatrogenic menopause, caused by:
• Bilateral oophorectomy
• Chemotherapy or radiotherapy-induced ovarian failure
• Other pharmacological treatments resulting in ovarian insuftficiency
• \. Women evaluated at the specialized Menopause Clinic or the Multidisciplinary Endocrinology/Metabolic Disorders clinic.
• \. 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.
• \. All women are eligible regardless of concomitant diseases, to reflect real-world clinical practice.

You may not qualify if:

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

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Related Publications (9)

• Haberland C, Barclay M, Lehane A, Whyman S, Gater A, Wikstrom H, Seitz C, Schoof N, Trigg A, Bradley H. Exit Interviews Examining Changes to Mood and Work/Productivity Impacts Related to Vasomotor Symptoms: Perspectives of Postmenopausal Women Receiving Elinzanetant in Phase III Clinical Trials. Patient. 2025 Nov;18(6):687-697. doi: 10.1007/s40271-025-00748-4. Epub 2025 Jul 12.

  PMID: 40650860 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• Hill K. The demography of menopause. Maturitas. 1996 Mar;23(2):113-27. doi: 10.1016/0378-5122(95)00968-x.

  PMID: 8735350 RESULT

MeSH Terms

Conditions

Osteoporosis, Postmenopausal; Primary Ovarian Insufficiency; Osteoporosis; Hot Flashes

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Target Duration: 20 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: May 19, 2026
• First Posted: May 26, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 1, 2040
• Study Completion (Estimated): December 1, 2040
• Last Updated: May 26, 2026

Record last verified: 2026-05