A Study of a Sleep Supplement to Improve Sleep in Women Going Through Menopause

What this trial studies

This study evaluated whether a daily dietary sleep supplement could improve sleep in women aged 40 to 65 who experience moderate sleep disturbances during menopause. Participants were randomly assigned to take either the supplement or a placebo for about three weeks. All study visits were conducted virtually. Sleep was assessed through daily diaries and weekly questionnaires measuring sleep quality, nighttime awakenings, daytime alertness, and mood.

Conditions in scope

• Sleep Disturbance

Interventions

• Sleep Supplement (Dietary Supplement) — A daily dietary sleep supplement taken once per day for 21 days.
• Placebo (Drug) — A placebo matched in appearance and dosing schedule to the sleep supplement, taken once per day for 21 days.

Who can join

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

Inclusion criteria

• Healthy women who are 40 to 65 years of age (inclusive).
• Have a body mass index (BMI) between 18.5 to 34.9 kg/m2 (inclusive).
• PROMIS SD SF T-Score Cut Point ≥ 60 (equivalent to a raw score of 30).
• Women enrolled in this research study may be of perimenopausal, (12 or more months without a menstrual period) or post-menopausal status.
• Post-menopause defined as the last natural menstrual period (LNMP) completed at least 12 months prior to screening.
• Perimenopause defined as women who complained of irregular menstrual cycle in the past 12 months, with a forward or postponed cycle more than 7 days.
• i. At least 2 cycles were missing during the past 12 months or reported menopause for at least 60 days.
• In good general health (no active or uncontrolled diseases or conditions) and able to consume the study product.

Exclusion criteria

• Individuals who are lactating, pregnant, or planning to become pregnant during the study.
• Perimenopausal women who are sexually active will be required to specify contraceptive method or be excluded.
• Currently incarcerated prisoners.
• Currently enrolled in a different clinical trial.
• Previous use of SAM-e, PG, GABA, Theanine, and/or Magnesium (unless in a multivitamin) within 3 months prior to screening.
• Use of any treatment for sleep symptoms or other concomitant treatments listed in Section 12.4.
• Taking blood thinners within the last 2 weeks. Further details may be found in Section 12.4.
• Have a known sensitivity, intolerability, or allergy to any of the study products or their excipients.

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: Interventional
• Phase: N/A
• Start date: 2023-10-10
• Primary completion: 2024-04-07
• Last update posted: 2026-01-29
• First posted: 2026-01-29

Sponsor & contact

Lead sponsor: Bonafide Health (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

• Change in Patient-Reported Outcomes Measurement Information System (PROMIS®) Sleep Disturbance Short Form 8b T-score (Day -7 (run-in baseline) to Day 21 (±3 days))
  Change from baseline in the Patient-Reported Outcomes Measurement Information System (PROMIS®) Sleep Disturbance Short Form 8b T-score, a validated patient-reported outcome measure assessing perceived sleep quality, difficulty falling or staying asleep, and overall sleep satisfaction over the prior 7 days. The PROMIS Sleep Disturbance Short Form 8b yields raw scores ranging from 8 to 40, which are converted to standardized…
• Responder Rate for Patient-Reported Outcomes Measurement Information System (PROMIS®) Sleep Disturbance Short Form 8b (Day -7 (run-in baseline) to Day 21 (±3 days))
  Responder rate defined as the proportion of participants achieving a clinically meaningful improvement in sleep disturbance, as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS®) Sleep Disturbance Short Form 8b T-score. The PROMIS Sleep Disturbance Short Form 8b yields raw scores ranging from 8 to 40, corresponding to standardized T-scores ranging from 28.9 to 76.5, with higher scores indicating…
• Change in Patient-Reported Outcomes Measurement Information System (PROMIS®) Sleep-Related Impairment Short Form 8a T-score (Day -7 (run-in baseline) to Day 21 (±3 days))
  Change from baseline in the Patient-Reported Outcomes Measurement Information System (PROMIS®) Sleep-Related Impairment Short Form 8a T-score, a validated patient-reported outcome measure assessing daytime alertness, sleepiness, fatigue, and functional impairment related to sleep over the prior 7 days. The PROMIS Sleep-Related Impairment Short Form 8a yields raw scores ranging from 8 to 40, which are converted to standardized T-scores ranging…
• Responder Rate for Patient-Reported Outcomes Measurement Information System (PROMIS®) Sleep-Related Impairment Short Form 8a (Day -7 (run-in baseline) to Day 21 (±3 days))
  Responder rate defined as the proportion of participants achieving a clinically meaningful improvement in sleep-related impairment, as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS®) Sleep-Related Impairment Short Form 8a T-score. The PROMIS Sleep-Related Impairment Short Form 8a yields raw scores ranging from 8 to 40, corresponding to standardized T-scores ranging from 30.0 to 80.1, with higher scores indicating…

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.