Impact of Hot Flashes on Sleep and Mood Disturbance

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-03

Study Completion Date

2012-01-04

Brief Summary

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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.

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Detailed Description

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Conditions

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Menopause Depression Hot Flashes

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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GnRH Agonist Injection

We will be administering an injection of leuprolide acetate (a GnRH agonist) to all participants.

Group Type EXPERIMENTAL

leuprolide

Intervention Type DRUG

Leuprolide acetate is a widely used GnRH agonist. In this protocol, leuprolide will be administered at a dose routinely used for treatment of endometriosis and uterine fibroids in women (one 3.75-mg intramuscular injection).

Interventions

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leuprolide

Leuprolide acetate is a widely used GnRH agonist. In this protocol, leuprolide will be administered at a dose routinely used for treatment of endometriosis and uterine fibroids in women (one 3.75-mg intramuscular injection).

Intervention Type DRUG

Other Intervention Names

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Lupron

Eligibility Criteria

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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 \<3ng/mL
* Clinically significant abnormalities in screening blood tests
* BMI \> 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes