No More Sleepless Nights in Perimenopause

What this trial studies

The goal of the clinical trial is to learn if Hormone Replacement Therapy (HRT) and Cognitive Behavioral Therapy (CBT-I) can treat insomnia in menopausal women. The main questions it aims to answer are: * Are HRT and CBT-I effective in reducing insomnia in menopausal women? * Are HRT and CBT-I comparable in terms of reducing insomnia severity in this population? Researchers will compare HRT and CBT-I to an active control group, receiving sleep hygiene instructions.

Conditions in scope

• Insomnia
• Menopause

Interventions

• Cognitive Behavioural Therapy for Insomnia (CBT-I) (Behavioral) — CBT-I is conducted in an individual setting according to the manual used in McCurry (1). Factors at the level of behavior, cognitions, and physiology that perpetuate sleep onset and sleep maintenance disorders are addressed. In addition, psychoeducation on sleep and…
• Hormone Replacement Therapy (HRT) (Drug) — Standard-dose continuously-combined bio-identical HRT containing transdermal estradiol 1.5 mg/d (= 2 strokes of Oestrogel® Dispenser) and oral micronized progesterone (= 1 capsule of Utrogestan® 200). This combination is the most popular HRT regimen, as it has a neutral effect on…
• Sleep Hygiene (Behavioral) — Sleep hygiene refers to healthy sleep habits, e.g. food and drink choices, a regular sleep schedule, evening routine. Although being widely used in daily practice, sleep hygiene shows no significant effect as monotherapy in patients with an established insomnia. The…

Who can join

Women only · Ages 45 Years to 69 Years · Accepts healthy volunteers.

Inclusion criteria

• Late menopausal transition according to Stages of Reproductive Aging criteria (STRAW+10)
• Pittsburgh Sleep Quality Index (PSQI) score \> 5
• Insomnia Severity Index (ISI) score \> 7
• Somato-vegetative domain of the Menopause Rating Scale (MRS)-II ≥ 4 points
• Willingness to use HRT for menopausal symptom reliefs

Exclusion criteria

• Other sleep-wake disorders according to DSM-5, assessed with validated questionnaires (Sleep-Health Questionnaire, Epworth Sleepiness Scale (ESS))
• Untreated hormonal disorder
• Obesity (BMI ≥ 30)
• Current psychotherapy
• Current psychopharmacological therapy including regular sleep medication
• History of unsuccessful CBT-I
• Psychiatric illness
• Substance abuse (≥ 7 cigarettes/day, no more than 2 standard WHO drinks per day, other drugs)

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: Recruiting
• Study type: Interventional
• Phase: PHASE4
• Start date: 2026-01-01
• Primary completion: 2026-07-01
• Last update posted: 2026-01-13
• First posted: 2024-07-12

Sponsor & contact

Lead sponsor: Insel Gruppe AG, University Hospital Bern (Other)

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

• Reduction of Insomnia Severity (Week 10)
  Change from baseline in Insomnia Severity Index (ISI). The ISI is a seven-item questionnaire, asking respondents to rate the severity of sleep-related symptoms on 5-point Likert scales (Ranging between 0 = not applicable and 4 = very strong). Total values may range between 0 and 28, where 0 indicates no presence of sleep-related symptoms and 28 indicates very severe symptoms.

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.