Medroxyprogesterone Compared With Venlafaxine in Treating Hot Flashes in Women

July 12, 2016 updated by: Alliance for Clinical Trials in Oncology

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

227

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: venlafaxine
Experimental: 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.
Drug: medroxyprogesterone
Experimental: 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.
Drug: medroxyprogesterone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Compare the efficacy of the three regimens
Time Frame: Up to one year post-treatment
Up to one year post-treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Determine whether there is cross resistance between these 2 drugs in these patients
Time Frame: Up to 1 year post-treatment
Up to 1 year post-treatment
Compare the 1-year efficacy of these regimens in these patients
Time Frame: Up to 1 year post-treatment
Up to 1 year post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alliance for Clinical Trials in Oncology

Collaborators

National Cancer Institute (NCI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2002

Primary Completion (Actual)

February 1, 2006

Study Completion (Actual)

September 1, 2006

Study Registration Dates

First Submitted

February 14, 2002

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

July 13, 2016

Last Update Submitted That Met QC Criteria

July 12, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCCTG-N99C7
  • CDR0000069217 (Registry Identifier: PDQ (Physician Data Query))
  • NCI-P02-0204

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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