What Do Female Hormones Do?
Estrogen and progesterone are the two primary female hormones made by the ovaries. Hormones are chemicals produced by the body and released into the bloodstream to help regulate the functions of various organs.
Before menopause, estrogen and progesterone work together to control the reproductive cycle. They regulate the buildup of the lining of the uterus to prepare a woman's body for the implantation of a fertilized egg. If fertilization does not take place, estrogen and progestin levels fall, and the menstrual period occurs.
After a hysterectomy (including the removal of the ovaries, where estrogen is produced), estrogen therapy can help relieve menopause symptoms like hot flashes, night sweats and uncomfortable vaginal dryness.
Estrogen loss affects other areas of the body besides the reproductive system. Estrogen especially has a significant effect on the skeletal system. When estrogen levels are low after menopause, bones can become more brittle. That's why estrogen therapy plays an important role in preventing osteoporosis.
Important Safety Information
What is CLIMARA used for?
CLIMARA is used after menopause to:
- Reduce moderate to severe hot flashes
- Treat moderate to severe dryness, itching, and burning in or around the vagina
- Treat certain conditions in which a young woman's ovaries do not produce enough estrogen naturally
- Help reduce your chances of getting osteoporosis (thin weak bones)
When prescribing solely for vaginal dryness or osteoporosis, other treatments should be considered.
What is the most important information I should know about CLIMARA (an estrogen hormone)?
- Estrogens increase the chances of getting cancer of the uterus.
Report any unusual vaginal bleeding right away while you are taking estrogens. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your healthcare provider should check any unusual vaginal bleeding to find out the cause.
- Do not use estrogens with or without progestins to prevent heart disease, heart attacks, strokes, or dementia.
Using estrogens with or without progestins may increase your chances of getting heart attack, strokes, breast cancer, and blood clots. Using estrogens with progestins may increase your risk of dementia.
You and your healthcare provider should talk regularly about whether you still need treatment with CLIMARA.
What is CLIMARA PRO used for?
CLIMARA PRO is used after menopause to:
- Reduce moderate to severe hot flashes.
- Help prevent osteoporosis (thin weak bones).
When prescribing solely for osteoporosis, other treatments should be considered.
What is the most important information I should know about CLIMARA PRO (combination of estrogen and progestin hormones)?
- Do not use estrogens with or without progestins to prevent heart disease, heart attacks, or strokes.
Using estrogens and progestins may increase your chances of getting heart attacks, strokes, breast cancer, and blood clots.
- Do not use estrogens with or without progestins to prevent dementia
Using estrogens with progestins may increase your risk of dementia.
You and your healthcare provider should talk regularly about whether you still need treatment with CLIMARA PRO.
Who should not use CLIMARA and CLIMARA PRO? Do not use CLIMARA PRO if you have had your uterus removed (hysterectomy).
Do not start using CLIMARA if you have unusual vaginal bleeding, currently have or have had certain cancers, had a stroke or heart attack in the past year, currently have or have had blood clots, currently have or have had liver problems, are allergic to CLIMARA or CLIMARA PRO or any of its ingredients, or think you may be pregnant.
What are the warnings of less common but serious side effects of CLIMARA or CLIMARA PRO?
Warnings of less common but serious side effects of CLIMARA or CLIMARA PRO include breast lumps, unusual vaginal bleeding, dizziness and faintness, changes in speech, severe headaches, chest pain, shortness of breath, pains in your legs, changes in vision, and vomiting. Call your healthcare provider right away if you get any of these warning signs, or any other unusual symptom that concerns you.
What are common side effects of CLIMARA or CLIMARA PRO?
Common side effects of CLIMARA include headache, breast pain, irregular vaginal bleeding or spotting, stomach/abdominal cramps, bloating, nausea and vomiting, and hair loss.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
For important risk and use information, please see the full prescribing information.
