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Medroxyprogesterone Compared With Venlafaxine in Treating Hot Flashes in Women

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ClinicalTrials.gov Identifier: NCT00030914
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : July 13, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Brief 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.


Condition or disease Intervention/treatment Phase
Hot Flashes Drug: medroxyprogesterone Drug: venlafaxine Phase 3

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  (Clinical Trial)
Actual Enrollment : 227 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Phase III Comparison of Depomedroxyprogesterone Acetate (DPROV) to Venlafaxine for Managing Hot Flashes
Study Start Date : April 2002
Primary Completion Date : February 2006
Study Completion Date : September 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. Compare the efficacy of the three regimens [ Time Frame: Up to one year post-treatment ]

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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:

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00030914


  Show 22 Study Locations
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Investigators
Study Chair: Charles L. Loprinzi, MD Mayo Clinic

Publications:
Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00030914     History of Changes
Other Study ID Numbers: NCCTG-N99C7
CDR0000069217 ( Registry Identifier: PDQ (Physician Data Query) )
NCI-P02-0204
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: July 13, 2016
Last Verified: July 2016

Keywords provided by Alliance for Clinical Trials in Oncology:
hot flashes

Additional relevant MeSH terms:
Hot Flashes
Signs and Symptoms
Venlafaxine Hydrochloride
Medroxyprogesterone
Medroxyprogesterone Acetate
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Male
Antineoplastic Agents, Hormonal
Antineoplastic Agents