Medroxyprogesterone Compared With Venlafaxine in Treating Hot Flashes in Women

Sponsor

Alliance for Clinical Trials in Oncology (Other)

Overall Status

Completed

CT.gov ID

NCT00030914

Collaborator

National Cancer Institute (NCI) (NIH)

227

Enrollment

Locations

Arms

Duration (Months)

10.3

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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 Design

Study Type:

Interventional

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 :

Apr 1, 2002

Actual Primary Completion Date :

Feb 1, 2006

Actual Study Completion Date :

Sep 1, 2006

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Compare the efficacy of the three regimens [Up to one year post-treatment]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CCOP - Mayo Clinic Scottsdale Oncology Program	Scottsdale	Arizona	United States	85259-5404
2	Mayo Clinic - Jacksonville	Jacksonville	Florida	United States	32224
3	MBCCOP - Hawaii	Honolulu	Hawaii	United States	96813
4	CCOP - Illinois Oncology Research Association	Peoria	Illinois	United States	61602
5	CCOP - Carle Cancer Center	Urbana	Illinois	United States	61801
6	CCOP - Cedar Rapids Oncology Project	Cedar Rapids	Iowa	United States	52403-1206
7	CCOP - Iowa Oncology Research Association	Des Moines	Iowa	United States	50309-1016
8	Siouxland Hematology-Oncology	Sioux City	Iowa	United States	51101-1733
9	CCOP - Wichita	Wichita	Kansas	United States	67214-3882
10	CCOP - Michigan Cancer Research Consortium	Ann Arbor	Michigan	United States	48106
11	CCOP - Duluth	Duluth	Minnesota	United States	55805
12	Mayo Clinic Cancer Center	Rochester	Minnesota	United States	55905
13	Coborn Cancer Center	Saint Cloud	Minnesota	United States	56303
14	CCOP - Missouri Valley Cancer Consortium	Omaha	Nebraska	United States	68106
15	Medcenter One Health System	Bismarck	North Dakota	United States	58501-5505
16	CCOP - Toledo Community Hospital	Toledo	Ohio	United States	43623-3456
17	CCOP - Oklahoma	Tulsa	Oklahoma	United States	74136
18	Allegheny General Hospital	Pittsburgh	Pennsylvania	United States	15212-4772
19	CCOP - Upstate Carolina	Spartanburg	South Carolina	United States	29303
20	Rapid City Regional Hospital	Rapid City	South Dakota	United States	57709
21	CCOP - Sioux Community Cancer Consortium	Sioux Falls	South Dakota	United States	57104
22	CCOP - St. Vincent Hospital Cancer Center, Green Bay	Green Bay	Wisconsin	United States	54301