Phase 4
Completed N=29
Impact of Hot Flashes on Sleep and Mood Disturbance
Menopause · Depression · Hot Flashes
Source: ClinicalTrials.gov NCT01116401 ↗
Enrolled (actual)
29
Serious AEs
0.0%
Results posted
Dec 2017
Primary outcomePrimary: Percent Change in Wake After Sleep Onset (WASO) — 62 percent change — p=0.007
◆ Published Evidence
Established
78citations · ~6 / year
A gonadotropin-releasing hormone agonist model demonstrates that nocturnal hot flashes interrupt objective sleep.
Summary
We plan to enroll premenopausal women in a trial investigating the impact of hot flashes developed in response to an injection of a gonadotropin-releasing hormone agonist (GnRHa), leuprolide (brand name: Lupron), on sleep disruption and mood. This study is designed to mimic the menopause transition. We will collect data on sleep disruption and mood changes to assess their relationship to the development of hot flashes.
Linked Publications (3)
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A gonadotropin-releasing hormone agonist model demonstrates that nocturnal hot flashes interrupt objective sleep.
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Independent Contributions of Nocturnal Hot Flashes and Sleep Disturbance to Depression in Estrogen-Deprived Women.
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Nocturnal Hot Flashes: Relationship to Objective Awakenings and Sleep Stage Transitions.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in Wake After Sleep Onset (WASO) |
62 | 0.007 sig |
| SECONDARY Change in Montgomery-Asperg Depression Rating Scale (MADRS) |
3.1 | <0.01 sig |
Eligibility Criteria
Inclusion Criteria
- Women 18-45 years old
- Premenopausal
- Willingness to use barrier methods of contraception during study and after completion of study until menses resume
- Good general health
Exclusion Criteria
- Pregnancy or currently breastfeeding
- Hot flushes
- Mid-luteal phase progesterone 35 kg/m2
- Previously diagnosed osteoporosis or osteopenia
- Clinically significant depressive symptoms
- Psychiatric illness
- Sleep apnea or periodic limb movement of sleep (PLMS)
- Contraindication, hypersensitivity, or previous allergic reaction to GnRH agonists
- Current or recent use of centrally active medications
- Current or recent use of systemic hormone medications
- Night shift workers
- Current use of over-the-counter (OTC) medications that may affect hot flashes, sleep, or mood
- Abnormal vaginal bleeding
- History of any medical diseases that may put subject at risk when treated with study medication.
Data sourced from ClinicalTrials.gov (NCT01116401) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.