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MenopauseNCT07606326

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

An observational study of Menopause and Menopausal Hormone Therapy, run by IRCCS San Raffaele.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 years, women only
How many people
5,000 participants
Where
No sites listed yet
Study dates
Jun 2026to Dec 2040
How long will I take part?
20 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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).

Who may be able to join

  • 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:
Show all 12Show fewer
  • 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.

Who cannot join

  • 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.

About this study

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.

Read more

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.

Read the 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.

Keywords
menopause, perimenopause, premature ovarian failure, hormonal replacement teraphy, osteoporosis, genitourinary syndrome of menopause, hot flashes, menopausal discomfort, menopausal symptoms
Medical subject headings
Osteoporosis, Postmenopausal, Primary Ovarian Insufficiency, Osteoporosis, Hot Flashes

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: From 2000 to 2040

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 May 2026
  2. Study startJun 2026 (estimated)
  3. Primary completionDec 2040 (estimated)
  4. Study completionDec 2040 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Other
Enrolment
5,000 participants (estimated)
Target duration
20 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT07606326
Sponsor's protocol ID
UNIVERSO MENOPAUSA
Status last verified
May 2026
First submitted
19 May 2026
Last updated
26 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 40650860
  • 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 101855
  • Hill K. The demography of menopause. Maturitas. 1996 Mar;23(2):113-27. doi: 10.1016/0378-5122(95)00968-x.

    PubMed 8735350

Questions about this trial

What is this clinical trial studying?

An observational study of Menopause and Menopausal Hormone Therapy, run by IRCCS San Raffaele.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07606326, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.

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