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Medroxyprogesterone Compared With Venlafaxine in Treating Hot Flashes in Women

Information source: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hot Flashes

Intervention: medroxyprogesterone (Drug); venlafaxine (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Alliance for Clinical Trials in Oncology

Official(s) and/or principal investigator(s):
Charles L. Loprinzi, MD, Study Chair, Affiliation: Mayo Clinic

Summary

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.

Clinical Details

Official title: Phase III Comparison of Depomedroxyprogesterone Acetate (DPROV) to Venlafaxine for Managing Hot Flashes

Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Primary outcome: Compare the efficacy of the three regimens

Secondary outcome:

Determine whether there is cross resistance between these 2 drugs in these patients

Compare the 1-year efficacy of these regimens in these patients

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. Patients are randomized to one of three treatment arms.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

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:

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)

Locations and Contacts

CCOP - Mayo Clinic Scottsdale Oncology Program, Scottsdale, Arizona 85259-5404, United States

Mayo Clinic - Jacksonville, Jacksonville, Florida 32224, United States

MBCCOP - Hawaii, Honolulu, Hawaii 96813, United States

CCOP - Illinois Oncology Research Association, Peoria, Illinois 61602, United States

CCOP - Carle Cancer Center, Urbana, Illinois 61801, United States

CCOP - Cedar Rapids Oncology Project, Cedar Rapids, Iowa 52403-1206, United States

CCOP - Iowa Oncology Research Association, Des Moines, Iowa 50309-1016, United States

Siouxland Hematology-Oncology, Sioux City, Iowa 51101-1733, United States

CCOP - Wichita, Wichita, Kansas 67214-3882, United States

CCOP - Michigan Cancer Research Consortium, Ann Arbor, Michigan 48106, United States

CCOP - Duluth, Duluth, Minnesota 55805, United States

Mayo Clinic Cancer Center, Rochester, Minnesota 55905, United States

Coborn Cancer Center, Saint Cloud, Minnesota 56303, United States

CCOP - Missouri Valley Cancer Consortium, Omaha, Nebraska 68106, United States

Medcenter One Health System, Bismarck, North Dakota 58501-5505, United States

CCOP - Toledo Community Hospital, Toledo, Ohio 43623-3456, United States

CCOP - Oklahoma, Tulsa, Oklahoma 74136, United States

Allegheny General Hospital, Pittsburgh, Pennsylvania 15212-4772, United States

CCOP - Upstate Carolina, Spartanburg, South Carolina 29303, United States

Rapid City Regional Hospital, Rapid City, South Dakota 57709, United States

CCOP - Sioux Community Cancer Consortium, Sioux Falls, South Dakota 57104, United States

CCOP - St. Vincent Hospital Cancer Center, Green Bay, Green Bay, Wisconsin 54301, United States

Additional Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: April 2002
Last updated: July 7, 2015

Page last updated: August 23, 2015

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