Understanding Experimentally Induced Hot Flushes

NCT00455689 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: 2005P-001512
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hot Flashes

Keywords

Lupron; Premenopausal; Hot flashes

Outcome Measures

Primary Outcomes (1)

• Percent Change in Objective Sleep Efficiency

  Objective sleep efficiency was measured using actigraphy. Sleep efficiency (percent of time spent asleep between bedtime and wake time) was calculated and averaged over 2 consecutive nights both before and 4 weeks after receiving the intervention.

  baseline (before receiving intervention) and 4 weeks after receiving intervention

Secondary Outcomes (1)

• Change in Subjective Sleep Quality

  baseline (before receiving intervention) and 4 weeks after receiving intervention

Study Arms (2)

Developed hot flashes

EXPERIMENTAL

Subjects who developed hot flashes after receiving leuprolide acetate (3.75 mg intramuscular injection)

Drug: Leuprolide acetate

Did not develop hot flashes

EXPERIMENTAL

Subjects who did not develop hot flashes after receiving leuprolide acetate (3.75 mg intramuscular injection)

Drug: Leuprolide acetate

Interventions

Leuprolide acetate DRUG

Leuprolide acetate (Lupron Depot®) 3.75-mg intramuscular injection Leuprolide is a widely used gonadotropin-releasing hormone agonist (GnRHa) that is indicated for treatment of endometriosis, uterine fibroids, precocious puberty, and prostate cancer, and is used off-label for in-vitro fertilization and premenstrual syndrome. In this protocol, leuprolide will be administered once during the mid-luteal phase of the menstrual cycle at a dose routinely used for treatment of endometriosis and uterine fibroids in women.

Also known as: Lupron

Developed hot flashes; Did not develop hot flashes

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
• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Endocrine Research Society: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• Joffe H, Deckersbach T, Lin NU, Makris N, Skaar TC, Rauch SL, Dougherty DD, Hall JE. Metabolic activity in the insular cortex and hypothalamus predicts hot flashes: an FDG-PET study. J Clin Endocrinol Metab. 2012 Sep;97(9):3207-15. doi: 10.1210/jc.2012-1413. Epub 2012 Jun 20.

  PMID: 22723326 DERIVED

MeSH Terms

Conditions

Hot Flashes

Interventions

Leuprolide

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

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, MD MSc
• Organization: Brigham & Women's Hospital

hjoffe@bwh.harvard.edu

617-732-4906

Study Officials

• Hadine Joffe, M.D., M.Sc.

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• 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: April 2, 2007
• First Posted: April 4, 2007
• Study Start: November 28, 2005
• Primary Completion: July 24, 2007
• Study Completion: September 2, 2007
• Last Updated: September 18, 2018
• Results First Posted: August 21, 2018

Record last verified: 2018-08

Locations

US (1)