Impact of Hot Flashes on Sleep and Mood Disturbance

NCT01116401 | Completed Phase 4 Results DMC

• 2 other identifiers: 2009-P-0015575R01MH082922
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Menopause; Depression; Hot Flashes

Keywords

Hot Flashes; Sleep disturbance; Lupron; Menopause

Outcome Measures

Primary Outcomes (1)

• Percent Change in Wake After Sleep Onset (WASO)

  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.

  baseline and 4 weeks

Secondary Outcomes (1)

• Change in Montgomery-Asperg Depression Rating Scale (MADRS)

  baseline and 4 weeks

Study Arms (1)

GnRH Agonist Injection

EXPERIMENTAL

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

Drug: leuprolide

Interventions

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).

Also known as: Lupron

GnRH Agonist Injection

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (3)

• Joffe H, Crawford SL, Freeman MP, White DP, Bianchi MT, Kim S, Economou N, Camuso J, Hall JE, Cohen LS. Independent Contributions of Nocturnal Hot Flashes and Sleep Disturbance to Depression in Estrogen-Deprived Women. J Clin Endocrinol Metab. 2016 Oct;101(10):3847-3855. doi: 10.1210/jc.2016-2348. Epub 2016 Sep 28.

  PMID: 27680875 DERIVED

• Bianchi MT, Kim S, Galvan T, White DP, Joffe H. Nocturnal Hot Flashes: Relationship to Objective Awakenings and Sleep Stage Transitions. J Clin Sleep Med. 2016 Jul 15;12(7):1003-9. doi: 10.5664/jcsm.5936.

  PMID: 26951410 DERIVED

• Joffe H, Crawford S, Economou N, Kim S, Regan S, Hall JE, White D. A gonadotropin-releasing hormone agonist model demonstrates that nocturnal hot flashes interrupt objective sleep. Sleep. 2013 Dec 1;36(12):1977-85. doi: 10.5665/sleep.3244.

  PMID: 24293774 DERIVED

MeSH Terms

Conditions

Depression; Hot Flashes; Parasomnias

Interventions

Leuprolide

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Results Point of Contact

• Title: Hadine Joffe
• Organization: Brigham & Women's Hospital

hjoffe@partners.org

617-732-4906

Study Officials

• Hadine Joffe, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Chair for Psychiatry Research

Study Record Dates

• First Submitted: May 3, 2010
• First Posted: May 5, 2010
• Study Start: November 3, 2009
• Primary Completion: December 29, 2011
• Study Completion: January 4, 2012
• Last Updated: January 23, 2018
• Results First Posted: December 26, 2017

Record last verified: 2017-12

Locations

US (1)