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Impact of Hot Flashes on Sleep and Mood Disturbance
Plain-language guide to NCT01116401: phase 4 interventional trial of Leuprolide, 29 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01116401
- Phase
- phase 4
- Status
- completed
- Start
- 2009-11-03
- Completion (planned or actual)
- 2011-12-29
- Participants
- 29 (actual)
- Design
- na, open label (everyone knows who gets what), basic_science
- Conditions studied
- Menopause; Depression; Hot Flashes
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
In this phase 4 trial, researchers set out to test Leuprolide.
The researchers 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.
The researchers will collect data on sleep disruption and mood changes to assess their relationship to the development of hot flashes.
It had 1 arm (groups): GnRH Agonist Injection (experimental).
The researchers will be administering an injection of leuprolide acetate (a GnRH agonist) to all participants.
The registry classes the interventions as drug.
Who Took Part
29 actual participants took part.
It was open to women only aged from 18 years up to 45 years.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: Women 18-45 years old. Willingness to use barrier methods of contraception during study and after completion of study until menses resume.
The full record lists 4 inclusion and 16 exclusion criteria; among the exclusions: pregnancy or currently breastfeeding; hot flushes; mid-luteal phase progesterone \<3ng/ml.
How the Study Was Run
It was run as a single-group and open-label study.
Being open-label, the Leuprolide study did not mask who received what.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2009-11-03 with completion listed for 2011-12-29.
It ran at 1 site in United States.
Its stated primary purpose is basic science.
What Was Measured
Researchers chose this as the main measure: Percent Change in Wake After Sleep Onset (WASO) (time frame: baseline and 4 weeks).
It also tracked 1 secondary outcome, for example Change in Montgomery-Asperg Depression Rating Scale (MADRS).
What This Means in Plain Language
Put simply, this is a phase 4 trial of Leuprolide in 29 people.
Its size is small, so on its own it can only give an early look.
The trial is marked completed; results are posted on the registry, and this page does not restate them.
More context: the Leuprolide compound page, all human trials.
Our Notes on the Compound
Leuprolide: A 9-amino-acid GnRH analog (Lupron, Eligard) that lowers sex-hormone levels with ongoing use; used in prostate cancer, endometriosis and early puberty.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.