Phase 4
N=29
Impact of Hot Flashes on Sleep and Mood Disturbance
Menopause · Depression · Hot Flashes
Bottom Line
View on ClinicalTrials.gov: NCT01116401 ↗Enrolled (actual)
29
Serious AEs
0.0%
Results posted
Dec 2017
Primary outcome: Primary: Percent Change in Wake After Sleep Onset (WASO) — 62 percent change — p=0.007
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- leuprolide (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Dec 2011
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 |
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.
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). 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.