WARNING
Estrogens and progestins should not be used for the prevention of cardiovascular disease.
The Women's Health Initiative (WHI) study reported increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women (50 to 79 years of age) during 5 years of treatment with conjugated estrogens (0.625 mg) combined with medroxyprogesterone acetate (2.5 mg) relative to placebo. (See CLINICAL PHARMACOLOGY, Clinical Studies.)
The Women's Health Initiative Memory Study (WHIMS), a substudy of WHI, reported increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with conjugated estrogens plus medroxyprogesterone acetate relative to placebo. It is unknown whether this finding applies to younger postmenopausal women or to women taking estrogen alone therapy. (See CLINICAL PHARMACOLOGY, Clinical Studies.)
Other doses of conjugated estrogens and medroxyprogesterone acetate, and other combinations and dosage forms of estrogens and progestins were not studied in the WHI clinical trials and, in the absence of comparable data, these risks should be assumed to be similar. Because of these risks, estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.
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PREMPRO SUMMARY
PREMPRO™ 0.3 mg/1.5 mg therapy consists of a single tablet containing 0.3 mg of the conjugated estrogens (CE) found in Premarin® tablets and 1.5 mg of medroxyprogesterone acetate (MPA) for oral administration.
PREMPRO or PREMPHASE therapy is indicated in women who have a uterus for the:
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Treatment of moderate to severe vasomotor symptoms associated with the menopause.
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Treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered.
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Prevention of postmenopausal osteoporosis. When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and for whom non-estrogen medications are not considered to be appropriate. (See CLINICAL PHARMACOLOGY, Clinical Studies.)
The mainstays for decreasing the risk of postmenopausal osteoporosis are weight-bearing exercise, adequate calcium and vitamin D intake, and when indicated, pharmacologic therapy. Postmenopausal women require an average of 1500 mg/day of elemental calcium. Therefore, when not contraindicated, calcium supplementation may be helpful for women with suboptimal dietary intake. Vitamin D supplementation of 400-800 IU/day may also be required to ensure adequate daily intake in postmenopausal women.
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NEWS HIGHLIGHTS
Published Studies Related to Prempro (Conjugated Estrogens / Medroxyprogesterone)
A randomized study of low-dose conjugated estrogens on sexual function and quality of life in postmenopausal women. [2009.03]
OBJECTIVE: To evaluate the effects of combined vaginal and oral low-dose estrogen plus progestogen therapy (EPT) on the frequency and severity of dyspareunia, sexual function, and quality of life in recently postmenopausal women... CONCLUSIONS: EPT provided a statistically significant improvement compared with placebo in dyspareunia, sexual experience, and quality of life as measured in this study. In general, EPT also improved self-reported sexual perception and enjoyment significantly compared with placebo.
A randomized study of low-dose conjugated estrogens on sexual function and quality of life in postmenopausal women. [2008.11.20]
OBJECTIVE:: To evaluate the effects of combined vaginal and oral low-dose estrogen plus progestogen therapy (EPT) on the frequency and severity of dyspareunia, sexual function, and quality of life in recently postmenopausal women... CONCLUSIONS:: EPT provided a statistically significant improvement compared with placebo in dyspareunia, sexual experience, and quality of life as measured in this study. In general, EPT also improved self-reported sexual perception and enjoyment significantly compared with placebo.
Effects of alcohol and cigarette smoking on change in serum estrone levels in postmenopausal women randomly assigned to fixed doses of conjugated equine estrogens with or without a progestin. [2008.03]
OBJECTIVE: To determine the effects of alcohol and smoking on serum estrone levels among women assigned to hormone therapy... CONCLUSIONS: Alcohol consumption augmented and smoking diminished serum estrone levels achieved while women were taking hormone therapy.
The effect of continuous combined conjugated equine estrogen plus medroxyprogesterone acetate and tibolone on cardiovascular metabolic risk factors. [2008]
OBJECTIVES: Hormone treatment (HT) after the menopause affects lipid and carbohydrate metabolism and inflammation and may modify risk factors relevant for the clinical expression of the metabolic syndrome and cardiovascular disease. Tibolone has pharmacodynamic properties different from other hormone preparations. Here, we compare the effect of combined HT and tibolone on metabolic risk markers for the development of cardiovascular disease... CONCLUSIONS: CEE/MPA and tibolone have comparable effects on most metabolic risk factors investigated. The effect of tibolone on fibrinolysis and triglycerides suggests that tibolone has a favorable pharmacological profile on these risk factors when compared to CEE/MPA.
Body composition during treatment with conjugated estrogens with and without medroxyprogesterone acetate: analysis of the women's Health, Osteoporosis, Progestin, Estrogen (HOPE) trial. [2007.08]
OBJECTIVE: The objective of the study was to determine the effects of several doses of conjugated estrogens (CE) and CE plus medroxyprogesterone acetate (MPA) on body composition (BC)... CONCLUSION: Treatment with CE or CE and MPA for up to 2 years does not affect BC.
Clinical Trials Related to Prempro (Conjugated Estrogens / Medroxyprogesterone)
Study Comparing Bioavailability of 3 New Formulations of Premarin/MPA With Premarin/MPA (PREMPRO) Reference Formulation [Completed]
This study will compare the bioavailabity of three new investigational combination
formulations of Premarin and medroxyprogesterone acetate (MPA) with a currently marketed
formulation of Premarin and MPA, Premproâ„¢. Premproâ„¢ is indicated for use after menopause in
women with a uterus to reduce moderate to severe hot flashes; to treat moderate to severe
dryness, itching, and burning, in and around the vagina; and to help reduce your chances of
getting osteoporosis (thin weak bones). The purpose of this study is to determine if these
new formulations of Premarin/MPA provide the same levels of estrogen and MPA in the blood as
Prempro in healthy postmenopausal women.
Study Comparing Bioequivalence of Two New Formulations of Premarin/MPA With Premarin/MPA Reference Formulation. [Completed]
This study will compare the bioequivalence of two new investigational combination
formulations of Premarin and medroxyprogesterone acetate (MPA) with a currently marketed
formulation of Premarin and medroxyprogesterone, Premproâ„¢.
Prempro is indicated for use after menopause in women with a uterus to reduce moderate to
severe hot flashes; to treat moderate to severe dryness, itching, and burning, in and around
the vagina; and to help reduce your chances of getting osteoporosis (thin weak bones). The
purpose of this study is to determine if these new formulations of Premarin and MPA provide
the same levels of estrogen and MPA in the blood as Prempro in healthy postmenopausal women.
Effects of Angeliq® and Premproâ„¢ on Blood Pressure and Sodium Sensitivity in Postmenopausal Women With Prehypertension [Recruiting]
The purpose of this study is to determine whether the study drug is safe and effective in the
treatment of prehypertension. The study will investigate the effects of
drospirenone/estradiol (Angeliq®) and medroxyprogesterone acetate/conjugated equine estrogen
(Premproâ„¢) on blood pressure and sodium sensitivity in postmenopausal women with
prehypertension.
Study Comparing Premarin®/MPA, PREMPRO® and Provera® in Healthy Postmenopausal Women [Recruiting]
The purpose of the study is to evaluate the safety and efficacy of new tablet formulations
of Premarin®/medroxyprogesterone (MPA).
Bioequivalence Study of 3 New Formulations of Premarin/MPA Compared With Premarin/MPA (Prempro) [Completed]
To evaluate three new investigational tablet formulations of the Food and Drug Administration
(FDA) approved medication Premproâ„¢, Premarin combined with medroxyprogesterone acetate
(MPA).
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 10 ratings/reviews, Prempro has an overall score of 6.40. The effectiveness score is 7.60 and the side effect score is 6.80. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
| | Prempro review by 48 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Highly Effective |
| Side effects: | | No Side Effects | | |
Treatment Info |
| Condition / reason: | | MENOPAUSE |
| Dosage & duration: | | 5MG taken 1 x day for the period of 3 MONTHS STILL USING |
| Other conditions: | | MENOPAUSE, NIGHTS SWEATS HOT FLASHES |
| Other drugs taken: | | NO | | |
Reported Results |
| Benefits: | | I AM GOING THROUGH MENOPAUSE, UP EVERY 20 MIN. HOT FASHES/COLD FASHES, NO SLEEP AT ALL. MOODY. ( MAY BE FROM LACK OF SLEEP). ALL DAY WORKING ONE MIN HOT NEXT MINUTE COLD. I STARTED THE PREMPRO IT TOOK ABOUT 2-3 WEEKS BUT NOW I SLEEP THROUGH THE NIGHT NO HOT FLASH, NO COLDNESS AND NOT NIGHT/DAY SWEATING. MY MOOD HAS IMPORVED. I DID GO OFF IT FOR 3 MONTHS AND ALL THE SYSTEMS CAME BACK. I WENT ON IT AND I WILL NOT GO OFF IT AGAIN. IT REALLY DID MAKE A DIFFERENCE FOR ME. |
| Side effects: | | NO SIDE EFFECTS |
| Comments: | | 1 PILL EVERY DAY. |
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| | Prempro review by 55 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Considerably Effective |
| Side effects: | | Severe Side Effects | | |
Treatment Info |
| Condition / reason: | | menopause |
| Dosage & duration: | | 3 months (dosage frequency: once) for the period of 3 months |
| Other conditions: | | hot flashes |
| Other drugs taken: | | none | | |
Reported Results |
| Benefits: | | hot flashes were less frequent. Libido was improved. Uninterrupted sleep was more common. Emotional balance was obtained |
| Side effects: | | I put on a lot of weight right away and frequently had tourinate and itching in the genital area and high blood pressure was noted |
| Comments: | | Upon visiting my doctor for my annual ob/gyn she recommended hormone replacement therapy to begin immediately. |
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| | Prempro review by 57 year old female patient | | | Rating |
| Overall rating: | | |
| Effectiveness: | | Ineffective |
| Side effects: | | Extremely Severe Side Effects | | |
Treatment Info |
| Condition / reason: | | severe hot flashes and night sweats |
| Dosage & duration: | | 0.3 mg-1.5 mg tablet taken one pill a day for the period of 33days |
| Other conditions: | | none |
| Other drugs taken: | | none | | |
Reported Results |
| Benefits: | | I had no treatment benefits. Did not stop the sweating, but I started bleeding vaginally quite heavy. I hadn't had a period in 6 years. Then this happened. I also had some mild cramping like you get when your period is going to start. Bright red blood, some clotting as well. Went off of of prempro after 33 days. I am still bleeding but I have been told that this will stop now that I have stopped prempro........also I suggest you look online and get informed about the severe side effects........my doctor in the end stated that she would never take them........would have been nice if she told me this before I did and when she prescribed them for me. |
| Side effects: | | all is said above |
| Comments: | | treated for heavy hot flashes and night sweats |
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Page last updated: 2009-10-20
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