Understanding Experimentally Induced Hot Flushes

NCT ID: NCT00455689

Last Updated: 2018-09-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-11-28
• Study Completion Date: 2007-09-02

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Developed hot flashes

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

Group Type: EXPERIMENTAL

Leuprolide acetate

Intervention Type: 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.

Did not develop hot flashes

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

Group Type: EXPERIMENTAL

Leuprolide acetate

Intervention Type: 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.

Interventions

Leuprolide acetate

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.

Intervention Type: DRUG

Other Intervention Names

Lupron

Eligibility Criteria

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
• 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
• Use of ketoconazole, clomiphene citrate, or anabolic/androgenic steroids in the preceding 3 months
• Renal insufficiency
• Abnormal vaginal bleeding
• History of thrombo-embolism or cardiovascular disease
• History of congestive heart failure or other conditions requiring sodium restriction
• History of spinal cord compression
• Metastatic vertebral lesions
• Memory disorders
• Urinary tract obstruction
• History of liver, kidney, pulmonary, or metabolic disease

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Endocrine Research Society

OTHER

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Hadine Joffe, MD

Vice Chair for Psychiatry Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hadine Joffe, M.D., M.Sc.

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 22723326 (View on PubMed)

Other Identifiers

2005P-001512

Identifier Type: -

Identifier Source: org_study_id