Phase 4
N=20
Understanding Experimentally Induced Hot Flushes
Hot Flashes
Bottom Line
View on ClinicalTrials.gov: NCT00455689 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Aug 2018
Primary outcome: Primary: Percent Change in Objective Sleep Efficiency — -2.6; 4.2 percent change
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Leuprolide acetate (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Jul 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in Objective Sleep Efficiency |
-2.6; 4.2 | — |
| SECONDARY Change in Subjective Sleep Quality |
2.5; 1.0 | — |
Summary
The purpose of the study is to examine the impact of hot flushes on sleep, mood, and well-being. The investigators will cause hot flushes by giving study participants the hormone medication, leuprolide (Lupron), which is a manufactured (artificial) hormone that makes the body think that it has reached menopause temporarily. Most women begin to have hot flushes within 4 weeks after taking leuprolide and resume menses 3 months later. The investigators will administer questionnaires to evaluate changes in sleep and mood over the course of the study.
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
- Breastfeeding
- Hot flushes
- Hemoglobin at the screening visit less than 10 gm/dL
- Abnormal liver function tests
- Abnormal renal function tests
- BMI > 35 kg/m2
- Previously diagnosed osteoporosis or osteopenia
- Psychiatric disorder involving mood, anxiety, psychotic disorder, current anorexia nervosa, or current alcohol or substance-use disorder
- Previous severe depression
- Evidence of suicidal or homicidal ideation
- Sleep apnea, narcolepsy, or other diagnosed sleep disorder
- Contraindication, hypersensitivity, or previous allergic reaction to GnRH agonists
- Regular use of centrally active medications
- Use of hormonal medications for at least 2 months
- Use of ketoconazole, clomiphene citrate, or anabolic/androgenic steroids in the preceding 3 months
- Renal insufficiency
- Abnormal vaginal bleeding
- History of thrombo-embolism or cardiovascular disease
- History of congestive heart failure or other conditions requiring sodium restriction
- History of spinal cord compression
- Metastatic vertebral lesions
- Memory disorders
- Urinary tract obstruction
- History of liver, kidney, pulmonary, or metabolic disease
Data sourced from ClinicalTrials.gov (NCT00455689). 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.