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Following menopausal women treated with non-hormonal therapy for hot flashes and night sweats

A Phase IV, Longitudinal, Observational Study Examining Real-World Outcomes of Non-Hormonal Pharmacotherapies Among Individuals Treated for Bothersome Vasomotor Symptoms

Astellas Pharma Inc · NCT06049797

This study is tracking menopausal women who are trying non-hormonal treatments for hot flashes and night sweats to see how well these options work in real life.

Quick facts

Study typeObservational
Enrollment1000 (estimated)
Ages40 Years to 75 Years
SexFemale
SponsorAstellas Pharma Inc (industry)
Locations61 sites (Birmingham, Alabama and 60 other locations)
Trial IDNCT06049797 on ClinicalTrials.gov

What this trial studies

This observational study will track women experiencing bothersome hot flashes and night sweats during menopause as they begin treatment with non-hormonal therapies prescribed by their healthcare providers. Participants will receive various non-hormonal treatments, including fezolinetant and several SSRIs and SNRIs, for up to one year. The study will involve both in-person and virtual visits, allowing for flexible participation. The aim is to gather real-world data on the effectiveness and outcomes of these therapies in managing vasomotor symptoms.

Who should consider this trial

Good fit: Ideal candidates are women diagnosed with bothersome vasomotor symptoms due to menopause who are starting a non-hormonal treatment.

Not a fit: Patients who do not experience bothersome hot flashes or night sweats may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into effective non-hormonal treatments for menopausal symptoms, improving quality of life for many women.

How similar studies have performed: Other studies have shown success with non-hormonal treatments for menopausal symptoms, indicating a promising approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Participant is diagnosed with bothersome VMS due to/associated with menopause for at least 3 months based on a standard of care assessment captured in consultation with an HCP including the participant's history, routine physical examination, and routine laboratory assessments.
* HCP has made the clinical decision to begin pharmacologic treatment with a non-HT including, a selective neurokinin 3 receptor (NK3-R) antagonist, an SSRI, SNRI, gabapentin, clonidine, pregabalin, oxybutynin or other non-HT, as part of the standard treatment for VMS. This may be the first course of treatment, a restart or a switch from one drug (HT/non- HT) to another non-HT. A restart or switch of a previous therapy requires a minimum of a 10-day period not on therapy/washout period prior to pre-baseline.
* Participant's health status is stable based on their medical history and general physical exam and determined to be a candidate for treatment with non-HTs.
* If participant has been prescribed an SSRI or SNRI for the treatment of depression or anxiety, they must be on a stable or consistent dose for a minimum of 3 months prior to screening.
* Participant has a negative urine pregnancy test at screening if not post-menopausal.
* Only for participants utilizing complementary and alternative therapies, mind-body techniques, or supplements for the treatment of VMS: participant has been on such therapies for ≥ 3 months prior to screening and intends to continue through duration of study.
* Confirmation has been made that the participant is able to obtain the prescribed non hormonal therapy (e.g., insurance coverage verified, participant has ability to self pay, or patient support program activated for at least 12 months for the uninsured participants, if applicable).

Exclusion Criteria:

* Participant is currently enrolled in any interventional or non-interventional wearable device study.
* Participant has any condition which makes the participant unsuitable for the study.
* Participant has a contraindication to the non-HT they are being prescribed for the treatment of VMS.
* Participant is currently taking hormonal contraceptives or other systemic HTs (including estrogen and/or progesterone, and/or testosterone preparations) and has not had a 10-day washout period prior to pre-baseline (vaginal/local estrogen preparations and levonorgestrel-releasing intrauterine system are not prohibited).
* Participant has presence of moderately severe or severe depression per standard of care assessment utilizing a standardized depression screening tool.
* Participant is currently pregnant or planning to become pregnant.
* Participant is post-menopausal and has a history of unexplained uterine bleeding within the last 6 months.
* Participant has pre-existing uncontrolled thyroid disease.
* Participant has unstable angina or participant has uncontrolled hypertension based on a standard of care assessment.

  * Participants who do not meet these criteria may be re-assessed after initiation or review of antihypertensive measures.
  * Participants with a medical history of hypertension can be enrolled once they are medically clear (stable and compliant).
* Participant has had insomnia unrelated to either menopause or bothersome VMS due to/associated with menopause.
* Participant has known substance abuse or alcohol addiction within 6 months of screening.
* Participant has been on intramuscular estradiol within 8 weeks of screening.
* Participant has a current diagnosis of a malignancy or history of a malignancy within the past 2 years (This does not include basal cell carcinoma or breast cancer.)
* Participants with metastatic (Stage 4) breast cancer.
* Participants who have been prescribed adjuvant endocrine therapy (tamoxifen or aromatase inhibitors with or without gonadotropin-releasing hormone analogues) for their non-metastatic (stage 0 to 3) breast cancer but have not maintained a stable treatment regimen for at least 3 months prior to screening.
* Participant has initiated hormone pellet therapy within 6 months of screening.

Where this trial is running

Birmingham, Alabama and 60 other locations

+11 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Hot Flashes, fezolinetant, vasomotor symptoms, menopause, night sweats, non-hormonal treatment

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.