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NCT00081952 Clinical Trial

Amino Acid Therapy for Hot Flashes in Postmenopausal Women

Hot Flashes Clinical Trial

Official title:
Amino Acid Therapy for Hot Flashes/Postmenopausal Women

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00081952
Other study ID # K23AT001709-01
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received April 27, 2004
Last updated March 21, 2013
Start date October 2003
Est. completion date October 2007

Study information
Verified date March 2013
Source National Center for Complementary and Integrative Health (NCCIH)
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine the safety, tolerability, and effectiveness of the amino acid L-isoleucine in the treatment of hot flashes in postmenopausal women.

Description:

Hot flashes affect approximately 75% of postmenopausal women. Although hormone replacement therapy (HRT) is highly effective in reducing hot flashes, long-term HRT is associated with increased rates of breast cancer and heart disease. Safe, effective, and well-tolerated hot flash therapies are needed. The amino acids L-methionine and L-isoleucine have produced reductions in hot flash frequency. However, long-term L-methionine therapy may increase cardiovascular risks. This study will evaluate the short-term effects of L-isoleucine therapy. Data from this study will be used to conduct long-term studies in the future.

Participants in this study will be randomly assigned to receive one of two different L-isoleucine doses for 2 weeks. Clinic visits will be made at baseline, Week 1, and Week 10. Participants will record the frequency and severity of their hot flashes in a diary.

Recruitment information / eligibility
Status Completed
Enrollment 15
Est. completion date October 2007
Est. primary completion date October 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria:

- Postmenopausal

- Experience over 5 hot flashes per day

Exclusion Criteria:

- Hormone Replacement Therapy (HRT) in the past 2 months

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• L-norleucine

Locations
Country Name City State
United States Women's Health Initiative Buffalo New York

Sponsors (1)
Lead Sponsor Collaborator
National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

See also
  Status Clinical Trial Phase
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Terminated NCT03642119 - Validation of an Objective Instrument to Measure Hot Flashes During Menopause
Completed NCT05061563 - A Study to Learn How a Proton Pump Inhibitor Affects the Way Elinzanetant (BAY 3427080) Moves Into, Through and Out of the Body, and How Much of it Gets Absorbed by the Body When Taken as a Single and Small Radioactive Dose in Healthy Adults Phase 1
Completed NCT05419908 - Trial to Investigate the Effect of ESN364 in Early Postmenopausal Women Suffering From Hot Flashes Phase 2
Completed NCT01281332 - Mechanical Device for the Relief of Hot Flashes Phase 2
Completed NCT01439945 - Magnesium Oxide in Treating Postmenopausal Women With Hot Flashes and a History of Breast Cancer Phase 2
Completed NCT00755417 - Study of Gabapentin Extended Release (G-ER) in the Treatment of Vasomotor (Hot Flashes/Hot Flushes) Symptoms in Postmenopausal Women Phase 3
Completed NCT00599456 - Investigation of the Usefulness of Omega 3 Vitamins in the Relief of Hot Flashes in Menopausal Women. N/A
Completed NCT01293695 - Hypnosis For Hot Flashes Among Postmenopausal Women in a Randomized Clinical Trial N/A
Completed NCT00256685 - Study Evaluating DVS-233 SR to Treat Vasomotor Systems Associated With Menopause Phase 3
Completed NCT00391417 - Efficacy and Safety of a Topical Estradiol Gel for Treatment of Postmenopausal Symptoms Phase 3
Terminated NCT00244894 - Acupuncture in Treating Hot Flashes in Patients With Prostate Cancer N/A
Completed NCT00010712 - Effects of Black Cohosh on Menopausal Hot Flashes Phase 2
Active, not recruiting NCT03580499 - Vitamin B6 in Reducing Hot Flashes in Participants With Prostate Cancer Undergoing Antiandrogen Therapy N/A
Recruiting NCT06030388 - Strength and Aerobic Training Against Hot Flushes in Postmenopausal Women N/A
Recruiting NCT04418115 - Fatigue as a Late Effect in Breast Cancer Survivors - is Acupuncture a Treatment Option? N/A
Recruiting NCT04861701 - Effect and Predictors for Hot Flush in Women Undergoing Static Stretching Exercise N/A
Active, not recruiting NCT05086705 - EMBr Wave for the Reduction of Hot Flashes in Women With a History of Breast Cancer N/A
Completed NCT05099159 - A Study to Learn More About How Well Elinzanetant Works and How Safe it is for the Treatment of Vasomotor Symptoms (Hot Flashes) That Are Caused by Hormonal Changes Over 26 Weeks in Women Who Have Been Through the Menopause (OASIS-2) Phase 3
Completed NCT01140646 - Evaluation of SAMe for Hot Flashes Phase 2