Medroxyprogesterone Compared With Venlafaxine in Treating Hot Flashes in Women - Full Text View

Sponsor:	North Central Cancer Treatment Group
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00030914

Purpose

RATIONALE: Medroxyprogesterone and venlafaxine may be effective in relieving hot flashes. It is not yet known whether venlafaxine is more effective than medroxyprogesterone in relieving hot flashes.

PURPOSE: Randomized phase III trial to compare the effectiveness of medroxyprogesterone with that of venlafaxine in treating women who are experiencing hot flashes.

Condition	Intervention	Phase
Hot Flashes	Drug: medroxyprogesterone Drug: venlafaxine	Phase III

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Open Label, Active Control
Official Title:	Phase III Comparison of Depomedroxyprogesterone Acetate (DPROV) to Venlafaxine for Managing Hot Flashes

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Venlafaxine Medroxyprogesterone 17-acetate Venlafaxine hydrochloride Medroxyprogesterone

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

April 2002

Detailed Description:

OBJECTIVES:

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.

Arm I: 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.
Arm II (closed to accrual as of 1/22/03): 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.
Arm III: 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.

PROJECTED ACCRUAL: A total of 220 patients (110 per treatment arm) will be accrued for this study within 18 months. (Arm II closed to accrual as of 1/22/03.)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

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:
- Not specified

PATIENT CHARACTERISTICS:

Age:

18 and over

Sex:

Female

Menopausal status:

Not specified

Performance status:

ECOG 0-1

Life expectancy:

At least 6 months

Hematopoietic:

Not specified

Hepatic:

Not specified

Renal:

Not specified

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:

Biologic therapy:

Not specified

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

Radiotherapy:

Not specified

Surgery:

Not specified

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00030914

Hide Study Locations

Locations

United States, Arizona
CCOP - Mayo Clinic Scottsdale Oncology Program
Scottsdale, Arizona, United States, 85259-5404
United States, Florida
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States, 32224
United States, Hawaii
MBCCOP - Hawaii
Honolulu, Hawaii, United States, 96813
United States, Illinois
CCOP - Carle Cancer Center
Urbana, Illinois, United States, 61801
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States, 61602
United States, Iowa
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, United States, 52403-1206
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, United States, 50309-1016
Siouxland Hematology-Oncology
Sioux City, Iowa, United States, 51101-1733
United States, Kansas
CCOP - Wichita
Wichita, Kansas, United States, 67214-3882
United States, Michigan
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, United States, 48106
United States, Minnesota
CCOP - Duluth
Duluth, Minnesota, United States, 55805
Coborn Cancer Center
Saint Cloud, Minnesota, United States, 56303
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
United States, Nebraska
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, United States, 68106
United States, North Dakota
Medcenter One Health System
Bismarck, North Dakota, United States, 58501-5505
United States, Ohio
CCOP - Toledo Community Hospital
Toledo, Ohio, United States, 43623-3456
United States, Oklahoma
CCOP - Oklahoma
Tulsa, Oklahoma, United States, 74136
United States, Pennsylvania
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212-4772
United States, South Carolina
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States, 29303
United States, South Dakota
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, United States, 57104
Rapid City Regional Hospital
Rapid City, South Dakota, United States, 57709
United States, Wisconsin
CCOP - St. Vincent Hospital Cancer Center, Green Bay
Green Bay, Wisconsin, United States, 54301

Sponsors and Collaborators

North Central Cancer Treatment Group

National Cancer Institute (NCI)

Investigators

Study Chair:

Charles L. Loprinzi, MD

Mayo Clinic

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

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. Epub 2006 Feb 27.

Study ID Numbers:	CDR0000069217, NCCTG-N99C7, NCI-P02-0204
Study First Received:	February 14, 2002
Last Updated:	May 9, 2009
ClinicalTrials.gov Identifier:	NCT00030914 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

hot flashes

Additional relevant MeSH terms:

Medroxyprogesterone 17-Acetate
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Contraceptive Agents
Antineoplastic Agents
Physiological Effects of Drugs
Contraceptives, Oral
Contraceptive Agents, Female
Hot Flashes
Psychotropic Drugs
Reproductive Control Agents
Contraceptive Agents, Male

Signs and Symptoms
Therapeutic Uses
Venlafaxine
Contraceptives, Oral, Synthetic
Antidepressive Agents, Second-Generation
Antidepressive Agents
Antineoplastic Agents, Hormonal
Serotonin Uptake Inhibitors
Pharmacologic Actions
Serotonin Agents
Medroxyprogesterone
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 27, 2009