Medroxyprogesterone Compared With Venlafaxine in Treating Hot Flashes in Women
NCT ID: NCT00030914
Last Updated: 2016-07-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
227 participants
INTERVENTIONAL
2002-04-30
2006-09-30
Brief Summary
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PURPOSE: Randomized phase III trial to compare the effectiveness of medroxyprogesterone with that of venlafaxine in treating women who are experiencing hot flashes.
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Detailed Description
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* Compare the efficacy of medroxyprogesterone administered as 1 injection vs medroxyprogesterone administered as 3 injections (closed to accrual as of 1/22/03) vs venlafaxine for hot flash alleviation in women with symptomatic hot flashes.
* Compare the toxic effects of these regimens in these patients.
* Determine whether there is cross resistance between these 2 drugs in these patients.
* Compare the 1-year efficacy of these regimens in these patients.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to age (18 to 49 vs 50 and over), current tamoxifen use (yes vs no), current raloxifene use (yes vs no), duration of hot flash symptoms (less than 9 months vs 9 months or more), and average frequency of hot flashes per day (2-3 vs 4-9 vs 10 or more). Patients are randomized to 1 of 2 treatment arms. (Arm II closed to accrual as of 1/22/03.)
All patients complete a daily questionnaire regarding number of hot flashes beginning on day 1 and continuing for 7 weeks. Patients are randomized to one of three treatment arms.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
NONE
Study Groups
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Arm I: venlafaxine
All patients complete a daily questionnaire regarding number of hot flashes beginning on day 1 and continuing for 7 weeks. Patients receive oral venlafaxine once daily for 6 weeks beginning on day 8. After week 7, patients with satisfactory efficacy may continue venlafaxine for up to 6 months. Patients with unsatisfactory efficacy may cross over to arm III.
Patients are followed at months 2, 3, 4, 5, 6, 8, 10, and 12.
venlafaxine
Arm II: medroxyprogesterone - long term
All patients complete a daily questionnaire regarding number of hot flashes beginning on day 1 and continuing for 7 weeks. Patients receive medroxyprogesterone intramuscularly (IM) on days 8, 22, and 36 for a total of 3 injections. After week 7, patients with unsatisfactory efficacy may cross over to arm I.
Patients are followed at months 2, 3, 4, 5, 6, 8, 10, and 12.
medroxyprogesterone
Arm III: medroxyprogesterone - short term
All patients complete a daily questionnaire regarding number of hot flashes beginning on day 1 and continuing for 7 weeks. Patients receive medroxyprogesterone IM once on day 8. After week 7, patients with unsatisfactory efficacy may cross over to arm I.
Patients are followed at months 2, 3, 4, 5, 6, 8, 10, and 12.
medroxyprogesterone
Interventions
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medroxyprogesterone
venlafaxine
Eligibility Criteria
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Inclusion Criteria
* History of breast cancer, ductal carcinoma in situ, or lobular carcinoma in situ (currently without evidence of malignant disease) OR
* Concerns about taking estrogen for fear of breast cancer
* Bothersome hot flashes, defined as occurrence at least 14 times per week and of sufficient severity as to make patient desire therapeutic intervention
* Presence of hot flashes for at least 1 month
* Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Sex:
* Female
Performance status:
* ECOG 0-1
Life expectancy:
* At least 6 months
Cardiovascular:
* No prior thromboembolic disease
* No uncontrolled hypertension (persistent diastolic blood pressure greater than 95 mm Hg and/or systolic blood pressure greater than 160 mm Hg)
Other:
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Chemotherapy:
* More than 4 weeks since prior antineoplastic chemotherapy
* No concurrent antineoplastic chemotherapy unless clinically appropriate
Endocrine therapy:
* More than 4 weeks since prior androgen or estrogen therapy
* More than 3 months since prior progesterone as part of hormone replacement therapy
* At least 1 year since any other progesterone therapy (including megestrol)
* No concurrent androgen, estrogen, or progestational agents unless clinically appropriate
* Concurrent tamoxifen, raloxifene, or aromatase inhibitors are allowed if started more than 4 weeks ago and continuation for more than 5 weeks is planned
Other:
* More than 2 weeks since prior agents for treatment of hot flashes (e.g., clonidine, Bellergal-S, or vitamin E of more than 400 mg per day)
* More than 1 year since prior antidepressants (including Hypericum perforatum \[St John's Wort\])
* No other concurrent antidepressants or monoamine oxidase inhibitors
* No other concurrent agents for treatment of hot flashes (e.g. clonidine, Bellergal-S, or vitamin E of more than 400 mg per day)
18 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Alliance for Clinical Trials in Oncology
OTHER
Responsible Party
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Principal Investigators
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Charles L. Loprinzi, MD
Role: STUDY_CHAIR
Mayo Clinic
Locations
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CCOP - Mayo Clinic Scottsdale Oncology Program
Scottsdale, Arizona, United States
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States
MBCCOP - Hawaii
Honolulu, Hawaii, United States
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States
CCOP - Carle Cancer Center
Urbana, Illinois, United States
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, United States
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, United States
Siouxland Hematology-Oncology
Sioux City, Iowa, United States
CCOP - Wichita
Wichita, Kansas, United States
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, United States
CCOP - Duluth
Duluth, Minnesota, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, United States
Coborn Cancer Center
Saint Cloud, Minnesota, United States
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, United States
Medcenter One Health System
Bismarck, North Dakota, United States
CCOP - Toledo Community Hospital
Toledo, Ohio, United States
CCOP - Oklahoma
Tulsa, Oklahoma, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States
Rapid City Regional Hospital
Rapid City, South Dakota, United States
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, United States
CCOP - St. Vincent Hospital Cancer Center, Green Bay
Green Bay, Wisconsin, United States
Countries
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References
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Loprinzi CL, Levitt R, Barton D, Sloan JA, Dakhil SR, Nikcevich DA, Bearden JD 3rd, Mailliard JA, Tschetter LK, Fitch TR, Kugler JW. Phase III comparison of depomedroxyprogesterone acetate to venlafaxine for managing hot flashes: North Central Cancer Treatment Group Trial N99C7. J Clin Oncol. 2006 Mar 20;24(9):1409-14. doi: 10.1200/JCO.2005.04.7324. Epub 2006 Feb 27.
Other Identifiers
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CDR0000069217
Identifier Type: REGISTRY
Identifier Source: secondary_id
NCI-P02-0204
Identifier Type: -
Identifier Source: secondary_id
NCCTG-N99C7
Identifier Type: -
Identifier Source: org_study_id
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