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Medroxyprogesterone Compared With Venlafaxine in Treating Hot Flashes in Women

This study has been completed.
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: February 14, 2002
Last updated: May 9, 2009
Last verified: August 2004

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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Phase III Comparison of Depomedroxyprogesterone Acetate (DPROV) to Venlafaxine for Managing Hot Flashes

Resource links provided by NLM:

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

Study Start Date: April 2002
Detailed Description:


  • 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.)


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


  • 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



  • 18 and over


  • Female

Menopausal status:

  • Not specified

Performance status:

  • ECOG 0-1

Life expectancy:

  • At least 6 months


  • Not specified


  • Not specified


  • Not specified


  • 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)


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception


Biologic therapy:

  • Not specified


  • 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


  • Not specified


  • Not specified


  • 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
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Please refer to this study by its identifier: NCT00030914

  Show 22 Study Locations
Sponsors and Collaborators
North Central Cancer Treatment Group
Study Chair: Charles L. Loprinzi, MD Mayo Clinic
  More Information

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

Keywords provided by National Cancer Institute (NCI):
hot flashes

Additional relevant MeSH terms:
Hot Flashes
Signs and Symptoms
Medroxyprogesterone Acetate
Antidepressive Agents
Antidepressive Agents, Second-Generation
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Central Nervous System Agents
Contraceptive Agents
Contraceptive Agents, Female
Contraceptive Agents, Male
Contraceptives, Oral
Contraceptives, Oral, Synthetic
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Reproductive Control Agents
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses processed this record on November 27, 2014