An Observational Study to Learn More About How Menopause Affects Women's Sleep and How They Are Being Treated for Sleep Problems

What this trial studies

This is an observational study in which data from women with sleep disturbances and vasomotor symptoms, also known as hot flashes, associated with menopause (SDM) are collected and studied. Menopause is part of a natural aging process and happens when women's menstrual cycles, also called periods, stop. Sleep disturbances, such as frequent waking up at night, are a common symptom (clinical sign) and a major worry associated with menopause that affects women's quality of life. The participants will continue to take their regular treatment for their SDM as agreed with their doctors.

Conditions in scope

• Sleep Disturbances Associated With Menopause

Interventions

• No study intervention (Other) — No visits or examinations, laboratory tests or procedures are mandated or required for this study. Providers in the study recruitment network will recruit eligible patients through an existing visit. After this referral, the study is conducted entirely electronically.

Who can join

Women only · Ages 40 Years to 65 Years · Accepts healthy volunteers.

Inclusion criteria

• Women experiencing menopause assigned female at birth, 40-65 years of age, residing in the United States.
• o Where being in the menopausal period is defined as at least 12 months of spontaneous amenorrhea prior to index date (the date informed consent was signed) or surgical bilateral oophorectomy with or without hysterectomy at least 6 weeks prior to index date.
• Sleep disturbances due to menopause, defined as self-reported disturbances characterized by waking up at night and/or poor quality of sleep (including difficulty falling asleep, short sleep, waking up early).
• Signed ICF by the patient.
• Provided access to medical records, directly granting access through the HRS platform and the provider's portal or providing contact information and a medical records release form.

Exclusion criteria

• Menopause induced chemically or from radiation therapy (i.e., chemotherapy).
• Medical conditions that impact sleep, including diagnosed chronic insomnia, sleep apnea, restless leg syndrome, circadian rhythm sleep disorder; current or history (except complete remission for 5 years or more) of any malignancy (except basal and squamous cell skin tumors).
• Women self-reporting being under the care of a HCP for suicidal ideation in the past six months, clinical anxiety in the past six months, or clinical depression in the past six months.
• Patients participating in a clinical trial.
• Pregnant women.

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

Where it’s happening

Status & timeline

• Overall status: Completed
• Study type: Observational
• Phase: N/A
• Start date: 2024-12-06
• Primary completion: 2025-08-29
• Last update posted: 2025-11-25
• First posted: 2024-12-11

Sponsor & contact

Lead sponsor: Bayer (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

• Number of awakenings in the night. (From Day 1 to Day 28.)
• Mean WASO (wakefulness after sleep onset) (From Day 1 to Day 28)
  Total number of minutes that a participant is awake after having initially fallen asleep
• Mean number of moderate or severe hot flashes per night (From Day 1 to Day 28)
• Mean sleep efficiency score (From Day 1 to Day 28)
  Defined as the percentage of time spent asleep while in bed
• Mean length of time (in minutes) to fall asleep (From Day 1 to Day 28)

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.