A Study Following Women in Menopause Treated With a Non-hormonal Therapy for Hot Flashes and Night Sweats

What this trial studies

Hot flashes and night sweats (also known as vasomotor symptoms or VMS) are the most common symptoms which bother women in menopause. This study will follow women going through menopause who have hot flashes and night sweats that cause them bother. They will be starting a non-hormonal therapy prescribed by their healthcare provider (HCP) to treat these symptoms. The women will visit their HCP's office, research center, or both.

Conditions in scope

• Hot Flashes

Interventions

• Fezolinetant (Drug) — Oral
• Paroxetine (Drug) — Oral
• Citalopram (Drug) — Oral
• Escitalopram (Drug) — Oral
• Desvenlafaxine (Drug) — Oral
• Venlafaxine (Drug) — Oral

Who can join

Women only · Ages 40 Years to 75 Years

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.

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Showing the first 10 of 48 sites. See all sites on ClinicalTrials.gov.

Status & timeline

• Overall status: Active, not recruiting
• Study type: Observational
• Phase: N/A
• Start date: 2023-11-15
• Primary completion: 2025-09-06
• Last update posted: 2026-04-29
• First posted: 2023-09-22

Sponsor & contact

Lead sponsor: Astellas Pharma Global Development, Inc. (Industry)

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Mean change from baseline to week 12 in symptom bother measured by the Menopause-Specific Quality of Life Domain (MENQoL) 1-week recall VMS domain score (Baseline and week 12)
  The MENQoL is a 29-item patient reported outcome (PRO) measure that assesses the impact of 4 domains of menopausal symptoms: vasomotor, psychosocial, physical, and sexual. Each item score ranges from 1 to 8, and each domain is scored separately; each domain mean ranges from 1 to 8. Higher scores represent more bothersome menopausal symptoms. A reduction (improvement) of 1 is…

Related ClearedRx care

If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.