Medroxyprogesterone Compared With Venlafaxine in Treating Hot Flashes in Women

NCT00030914 | Completed Phase 3 DMC

• 3 other identifiers: NCCTG-N99C7CDR0000069217NCI-P02-0204
• Study Type: interventional
• Target: 227
• Locations: 1 country
• Sites: 22

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.

Conditions

Hot Flashes

Keywords

hot flashes

Outcome Measures

Primary Outcomes (1)

• Compare the efficacy of the three regimens

  Up to one year post-treatment

Secondary Outcomes (2)

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

  Up to 1 year post-treatment

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

  Up to 1 year post-treatment

Study Arms (3)

Arm I: venlafaxine

EXPERIMENTAL

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

Arm II: medroxyprogesterone - long term

EXPERIMENTAL

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

Arm III: medroxyprogesterone - short term

EXPERIMENTAL

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

Interventions

medroxyprogesterone DRUG

Arm II: medroxyprogesterone - long term; Arm III: medroxyprogesterone - short term

venlafaxine DRUG

Arm I: venlafaxine

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Alliance for Clinical Trials in Oncology: lead
• National Cancer Institute (NCI): collaborator

Study Sites (22)

CCOP - Mayo Clinic Scottsdale Oncology Program

Scottsdale, Arizona, 85259-5404, United States

Location

Mayo Clinic - Jacksonville

Jacksonville, Florida, 32224, United States

Location

MBCCOP - Hawaii

Honolulu, Hawaii, 96813, United States

Location

CCOP - Illinois Oncology Research Association

Peoria, Illinois, 61602, United States

Location

CCOP - Carle Cancer Center

Urbana, Illinois, 61801, United States

Location

CCOP - Cedar Rapids Oncology Project

Cedar Rapids, Iowa, 52403-1206, United States

Location

CCOP - Iowa Oncology Research Association

Des Moines, Iowa, 50309-1016, United States

Location

Siouxland Hematology-Oncology

Sioux City, Iowa, 51101-1733, United States

Location

CCOP - Wichita

Wichita, Kansas, 67214-3882, United States

Location

CCOP - Michigan Cancer Research Consortium

Ann Arbor, Michigan, 48106, United States

Location

CCOP - Duluth

Duluth, Minnesota, 55805, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

Coborn Cancer Center

Saint Cloud, Minnesota, 56303, United States

Location

CCOP - Missouri Valley Cancer Consortium

Omaha, Nebraska, 68106, United States

Location

Medcenter One Health System

Bismarck, North Dakota, 58501-5505, United States

Location

CCOP - Toledo Community Hospital

Toledo, Ohio, 43623-3456, United States

Location

CCOP - Oklahoma

Tulsa, Oklahoma, 74136, United States

Location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212-4772, United States

Location

CCOP - Upstate Carolina

Spartanburg, South Carolina, 29303, United States

Location

Rapid City Regional Hospital

Rapid City, South Dakota, 57709, United States

Location

CCOP - Sioux Community Cancer Consortium

Sioux Falls, South Dakota, 57104, United States

Location

CCOP - St. Vincent Hospital Cancer Center, Green Bay

Green Bay, Wisconsin, 54301, United States

Location

Related Publications (1)

• 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. doi: 10.1200/JCO.2005.04.7324. Epub 2006 Feb 27.

  PMID: 16505409 RESULT

MeSH Terms

Conditions

Hot Flashes

Interventions

Medroxyprogesterone; Venlafaxine Hydrochloride

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hydroxyprogesterones; Progesterone; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Phenethylamines; Ethylamines; Amines; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Lipids

Study Officials

• Charles L. Loprinzi, MD

  Mayo Clinic

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2002
• First Posted: January 27, 2003
• Study Start: April 1, 2002
• Primary Completion: February 1, 2006
• Study Completion: September 1, 2006
• Last Updated: July 13, 2016

Record last verified: 2016-07

Locations

US (22)