What’s the study about?
The research team is studying two medicines that may help to reduce hot flashes in a study involving 8 weeks of treatment. One is a low-dose estrogen pill. This pill doesn’t include progesterone, and should not increase breast cancer risk when used for such a short period of time. The other is a serotonin-based pill called venlafaxine (brand name Effexor XR). It is currently used to help reduce hot flashes and to treat anxiety and depression. The researchers want to know if women who take these medicines have fewer or less severe hot flashes than women who take a placebo (inactive pill). They also want to determine if one medicine is more effective than the other.
If you sign up for the Comparison of Venlafaxine-XR and Low-Dose Estradiol for Treatment of Menopausal Symptoms study:
• You will be called to answer questions about your hot flashes, menopausal status, and health.
• If you meet the main study criteria, you will be asked to attend 2 clinic visits, about a week apart. These visits are to confirm that the study is a good fit for you and that you are eligible.
• If you are eligible and join the study, you will be asked to take one study pill per day for 8 weeks. You will receive low-dose estrogen, venlafaxine, or a placebo (inactive pill). Neither you nor the study staff will know which type of pill you are taking. At the end of the study, you will be told which medicine you took. Women who took estrogen and who have a uterus will take progesterone for 2 weeks to protect their uterus.
• You will be asked to come to 1-2 more clinic visits after you have been taking the study pills for 8 weeks.
• You will be asked to participate in 3 phone calls.
• Each of the clinic visits will take about an hour. During these visits, the researchers may:
o Check your blood pressure, pulse, height, weight, and waist and hip measurements.
o Ask you to do a urine pregnancy test if you have had a menstrual period in the past 12 months.
o Ask you to fill out a study form about your overall health, feelings, sleep, pain, bodily functions, and sexuality.
o Collect about 2 tablespoons of blood from a vein in your arm to make sure the study is a good fit for you.
• You will be asked to fill out diaries at home during the duration of the study. These will include a hot flash diary, vaginal bleeding diary, and sleep diary.
• The entire study lasts for 15 weeks.
Who is conducting the study?
• Hadine Joffe, MD, MSc, and Lee Cohen, MD, at Massachusetts General Hospital/Harvard Medical School, Boston, MA; JoAnn Manson, MD, DrPH, at Brigham and Women’s Hospital/Harvard Medical School, Boston, MA
• Susan Reed, MD, MPH, and Katherine Newton, PhD, at the University of Washington and Group Health Research Institute (GHRI), Seattle, WA
• Ellen Freeman, PhD, at the University of Pennsylvania School of Medicine, Philadelphia, PA
Massachusetts General Hospital and Brigham and Women’s Hospital/Harvard Medical School, Boston, MA
Group Health Research Institute (GHRI), Seattle, WA
University of Pennsylvania, Department of Obstetrics/Gynecology, Philadelphia, PA
Who can participate?
You can join the Comparison of Venlafaxine-XR and Low-Dose Estradiol for Treatment of Menopausal Symptoms study if you match ALL of these MAIN categories:
• You are a woman between ages 40 and 62
• You are peri- or postmenopausal
• You have bothersome hot flashes/night sweats
• You have NOT been diagnosed with endometrial, ovarian, or breast cancer
• You are NOT currently pregnant, breastfeeding, or planning to become pregnant
• You read, write, and speak English
• You live near or are willing to travel (at your own expense) to Boston, Seattle, or Philadelphia for 3 or more study visits.
After you RSVP, the research team will ask you additional questions to be sure that this study is a good fit for you.