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Completed

NCT Number: NCT01116401

Impact of Hot Flashes on Sleep and Mood Disturbance

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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Key information

Conditions

Menopause Behavior Behavioral Symptoms Depression Hot Flashes Mental Disorders Nervous System Diseases Parasomnias Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Wake Disorders

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Leuprolide

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).

Other names: Lupron

Primary outcomes

  1. Percent Change in Wake After Sleep Onset (WASO)

    Time frame: baseline and 4 weeks

    Wake after sleep onset (WASO) is calculated by averaging the number of minutes spent awake after initiating sleep each night from the two ambulatory polysomnography studies conducted at baseline and the two ambulatory polysomnography studies conducted four weeks after the GnRHa injection.

Secondary outcomes

  1. Change in Montgomery-Asperg Depression Rating Scale (MADRS)

    Time frame: baseline and 4 weeks

    The Montgomery-Åsberg Depression Rating Scale is a widely used 10-item clinician-rated scale that describes the severity of depressive symptoms. It has a range of 0-60 with higher scores indicating greater symptom burden. Participants were assessed at baseline and four weeks after the GnRHa injection in order to calculate the change in MADRS score.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Impact of Experimentally Induced Hot Flashes on Sleep and Mood Disturbance

Important dates

Study start
2009
Primary completion
2011
Study completion
2012
First posted
May 5, 2010
Registry last updated
Jan 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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