Supplemental Evidence and Data Request on Improving the Management of Menopausal Symptoms in Perimenopausal and Early Postmenopausal Women: A Systematic Review

<NOTICE> DEPARTMENT OF HEALTH AND HUMAN SERVICES <SUBAGY>Agency for Healthcare Research and Quality</SUBAGY> <SUBJECT>Supplemental Evidence and Data Request on Improving the Management of Menopausal Symptoms in Perimenopausal and Early Postmenopausal Women: A Systematic Review</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Agency for Healthcare Research and Quality (AHRQ), HHS. <HD SOURCE="HED">ACTION:</HD> Request for Supplemental Evidence and Data Submission. <SUM> <HD SOURCE="HED">SUMMARY:</HD> The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review on <E T="03">Improving the Management of Menopausal Symptoms in Perimenopausal and Early Postmenopausal Women: A Systematic Review,</E> which is currently being conducted by the AHRQ's Evidence-based Practice Centers (EPC) Program. Access to published and unpublished pertinent scientific information will improve the quality of this review. </SUM> <DATES> <HD SOURCE="HED">DATES:</HD> <E T="03">Submission Deadline</E> on or before April 17, 2025. </DATES> <HD SOURCE="HED">ADDRESSES:</HD> <E T="03">Email submissions: epc@ahrq.hhs.gov.</E> <E T="03">Print submissions:</E> <E T="03">Mailing Address:</E> Center for Evidence and Practice Improvement, Agency for Healthcare Research and Quality, ATTN: EPC SEADs Coordinator, 5600 Fishers Lane, Mail Stop 06E53A, Rockville, MD 20857. <E T="03">Shipping Address (FedEx, UPS, etc.):</E> Center for Evidence and Practice Improvement, Agency for Healthcare Research and Quality, ATTN: EPC SEADs Coordinator, 5600 Fishers Lane, Mail Stop 06E77D, Rockville, MD 20857. <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> Kelly Carper, Telephone: 301-427-1656 or Email: <E T="03">epc@ahrq.hhs.gov.</E> </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> The Agency for Healthcare Research and Quality has commissioned the Evidence-based Practice Centers (EPC) Program to complete a review of the evidence for <E T="03">Improving the Management of Menopausal Symptoms in Perimenopausal and Early Postmenopausal Women: A Systematic Review.</E> AHRQ is conducting this review pursuant to Section 902 of the Public Health Service Act, 42 U.S.C. 299a. The EPC Program is dedicated to identifying as many studies as possible that are relevant to the questions for each of its reviews. In order to do so, we are supplementing the usual manual and electronic database searches of the literature by requesting information from the public ( <E T="03">e.g.,</E> details of studies conducted). We are looking for studies that report on <E T="03">Improving the Management of Menopausal Symptoms in Perimenopausal and Early Postmenopausal Women: A Systematic Review.</E> The entire research protocol is available online at: <E T="03">https://effectivehealthcare.ahrq.gov/products/menopausal-symptoms/protocol.</E> This is to notify the public that the EPC Program would find the following information on <E T="03">Improving the Management of Menopausal Symptoms in Perimenopausal and Early Postmenopausal Women: A Systematic Review</E> helpful: A list of completed studies that your organization has sponsored for this topic. In the list, please <E T="03">indicate whether results are available on ClinicalTrials.gov along with the ClinicalTrials.gov trial number.</E> <E T="03">For completed studies that do not have results on ClinicalTrials.gov,</E> a summary, including the following elements, if relevant: study number, study period, design, methodology, indication and diagnosis, proper use instructions, inclusion and exclusion criteria, primary and secondary outcomes, baseline characteristics, number of patients screened/eligible/enrolled/lost to follow-up/withdrawn/analyzed, effectiveness/efficacy, and safety results. <E T="03">A list of ongoing studies that your organization has sponsored for this topic.</E> In the list, please provide the <E T="03">ClinicalTrials.gov</E> trial number or, if the trial is not registered, the protocol for the study including, if relevant, a study number, the study period, design, methodology, indication and diagnosis, proper use instructions, inclusion and exclusion criteria, and primary and secondary outcomes. Description of whether the above studies constitute <E T="03">ALL Phase II and above clinical trials</E> sponsored by your organization for this topic and an index outlining the relevant information in each submitted file. Your contribution is very beneficial to the Program. Materials submitted must be publicly available or able to be made public. Materials that are considered confidential; marketing materials; study types not included in the review; or information on topics not included in the review cannot be used by the EPC Program. This is a voluntary request for information, and all costs for complying with this request must be borne by the submitter. The draft of this review will be posted on AHRQ's EPC Program website and available for public comment for a period of 4 weeks. If you would like to be notified when the draft is posted, please sign up for the email list at: <E T="03">https://effectivehealthcare.ahrq.gov/email-updates.</E> <E T="03">The review will answer the following questions. This information is provided as background. AHRQ is not requesting that the public provide answers to these questions.</E> <HD SOURCE="HD1">Key Questions (KQ)</HD> <E T="03">KQ 1:</E> What are the effectiveness, comparative effectiveness, and harms of treatments for menopausal symptoms in perimenopausal and early postmenopausal women? a. Do the effectiveness, comparative effectiveness, and harms of treatment vary by dose, delivery mode, formulations, or duration of treatment? b. Do the effectiveness, comparative effectiveness, and harms of treatment vary by timing and type of menopause (early, average; iatrogenic, natural)? c. Do the effectiveness, comparative effectiveness, and harms of treatment vary by individual- or system-level factors? <E T="03">KQ 2:</E> What is the impact of individual- or system-level factors on the receipt of treatment for perimenopausal and early postmenopausal women with symptoms? a. Individual-level factors include but are not limited to educational attainment, patient engagement in healthcare, lifestyle factors, comorbidities. b. System-level factors include but are not limited to provider bias, access to care, and social determinants of health. <HD SOURCE="HD1"> PICOTS (Populations, Interventions, Comparators, Outcomes, Timing, and Setting) </HD> <GPOTABLE COLS="3" OPTS="L2,nj,i1" CDEF="s50,r100,r100"> <TTITLE>Table 1—PICOTS for KQ 1</TTITLE> <CHED H="1">Criteria</CHED> <CHED H="1">Inclusions</CHED> <CHED H="1">Exclusions</CHED> <ROW> <ENT I="01">Population</ENT> <ENT> Perimenopausal and early postmenopausal women with menopausal symptoms (new onset or worsening of vasomotor symptoms, genitourinary symptoms of menopause, and other symptoms) Eligible women are <10 years since menopause for Black and Hispanic women and <5 years for other women or are age <60; Figure 3 offers a decision algorithm to account for variability in reporting of age and years since menopause and longer duration in vasomotor symptoms by race or ethnicity. <E T="03">Vasomotor symptoms:</E> Hot flashes. Night sweats. <E T="03">Genitourinary symptoms of menopause:</E> Genital pain including vulvodynia/vestibulodynia/dyspareunia. Vulvovaginal dryness. Vulvovaginal itching/irritation/discomfort. Urinary pain including dysuria. Involuntary urine loss/urinary leakage or urinary frequency. Skin thinning. Pelvic floor dysfunction. <E T="03">Other symptoms:</E> Joint pain. Mood lability. Change in severity or persistence of mental health disorders. Cognitive changes. Sleep disturbances. </ENT> <ENT> Studies limited to specific populations such as breast cancer survivors or HIV carriers, women with pelvic organ prolapse. Studies solely comprising women with existing disorders ( <E T="03">e.g.,</E> mood, anxiety, sleep disturbances, sexual or urinary dysfunction, cognitive changes, endometriosis, fibroids, endometrial hyperplasia, polycystic ovarian syndrome). </ENT> </ROW> <ROW> <ENT I="22"> </ENT> <ENT O="xl"> <E T="03">Subgroups of interest (preplanned only):</E> </ENT> </ROW> <ROW> <ENT I="22"> </ENT> <ENT O="xl">Natural menopause.</ENT> </ROW> <ROW> <ENT I="22"> </ENT> <ENT O="xl"> Iatrogenic ( <E T="03">e.g.,</E> surgical) menopause, premature menopause, early menopause. </ENT> </ROW> <ROW> <ENT I="22"> </ENT> <ENT O="xl">Early perimenopausal women (prior to and through 1 year from the final menstrual period).</ENT> </ROW> <ROW> <ENT I="22"> </ENT> <ENT O="xl">Women with/without hysterectomy.</ENT> </ROW> <ROW> <ENT I="22"> </ENT> <ENT O="xl">Women at increased risk for breast cancer, women at increased risk for heart disease.</ENT> </ROW> <ROW> <ENT I="22"> </ENT> <ENT O="xl"> Individual- and system-level factors ( <E T="03">e.g.,</E> socioeconomic status, social determinants of health, race/ethnicity). <E T="03">Systemic hormone therapy (Appendix A):</E> FDA-approved hormone therapies: estrogens alone, estrogens + progestin, estrogens + progesterone, estrogens + androgen, androgens (including testosterone), micronized progesterone, synthetic progestins, tissue-selective estrogen complex ( <E T="03">e.g.,</E> CEE/bazedoxifene), compounded menopausal hormone therapy (compounded in 503B outsourcing facilities), <SU>b</SU> “bioidentical hormones”. <E T="03">Subgroups of interest (preplanned only):</E> Route of delivery: oral, transdermal, pellets (for cBHT), vaginal, intramuscular. <E T="03">Spe ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 24k characters. 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