Medroxyprogesterone Compared With Venlafaxine in Treating Hot Flashes in Women

• Status: Completed
• Trial end date: 2006-09-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alliance for Clinical Trials in Oncology
• Collaborator: National Cancer Institute (NCI)
• Treatments: Medroxyprogesterone; Medroxyprogesterone Acetate; Venlafaxine Hydrochloride

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)