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Prempro (Conjugated Estrogens / Medroxyprogesterone) - Summary

 
 



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.

 

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:

  1. Treatment of moderate to severe vasomotor symptoms associated with the menopause.
  2. 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.
  3. 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.


See all Prempro indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Prempro (Conjugated Estrogens / Medroxyprogesterone)

Effects of percutaneous estradiol-oral progesterone versus oral conjugated equine estrogens-medroxyprogesterone acetate on breast cell proliferation and bcl-2 protein in healthy women. [2011.03.01]
In a prospective, randomized clinical study 77 women were assigned randomly to receive sequential hormone therapy with either conventional oral conjugated equine estrogens (0.625 mg) with the addition on 14 of the 28 days of oral medroxyprogesterone acetate (5 mg) or natural E(2) gel (1.5 mg) with oral micronized P (200 mg) on 14 of the 28 days of each cycle.

Long-term effects of conjugated equine estrogen therapies on domain-specific cognitive function: results from the Women's Health Initiative study of cognitive aging extension. [2010.07]
OBJECTIVES: To determine whether small decrements in global cognitive function that conjugated equine estrogen (CEE) therapies have been shown to produce in older women persist after cessation and extend to specific cognitive domains... CONCLUSION: CEE-based therapies, when initiated after the age of 65, produce a small broad-based decrement in cognitive function that persists after their use is stopped, but the differences in cognitive function are small and would not be detectable or have clinical significance for an individual woman. Differences in effects between cognitive domains suggest that more than one mechanism may be involved.

Cardiovascular and metabolic effects of medroxyprogesterone acetate versus conjugated equine estrogen after premenopausal hysterectomy with bilateral ovariectomy. [2010.05]
STUDY OBJECTIVE: To compare the cardiovascular and metabolic effects of medroxyprogesterone acetate (MPA) with those of conjugated equine estrogen (CEE) as single-hormone therapies in women who underwent hysterectomy with bilateral ovariectomy... CONCLUSION: Therapy with CEE, but not MPA, after surgical menopause appears to predispose healthy women to low-grade inflammation, as evidenced by its independent associations with elevated CRP and reduced albumin levels. In women treated with MPA, the favorable levels of inflammatory markers, BMI, and triglyceride levels need to be confirmed in larger controlled trials, as progesterone therapy may provide a safe and effective alternative to estrogen for vasomotor symptoms in women with surgical menopause.

Cardiovascular and metabolic effects of medroxyprogesterone acetate versus conjugated equine estrogen after premenopausal hysterectomy with bilateral ovariectomy. [2010]
ovariectomy... CONCLUSION: Therapy with CEE, but not MPA, after surgical menopause appears to

Brain volumes, cognitive impairment, and conjugated equine estrogens. [2009.12]
BACKGROUND: Postmenopausal conjugated equine estrogens (CEE) therapies increase the risk of cognitive impairment in women aged 65 years or older and are associated with smaller regional brain volumes; however, the link between these two phenomena has not been established... CONCLUSION: A mechanism by which CEE-based postmenopausal hormone therapy induces cognitive impairment appears to be through increased brain atrophy.

more studies >>

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, Prempro™. 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/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, Prempro™.

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.

Bioidentical 'Natural' Hormone Evaluation in Early Menopause [Recruiting]
Prospective double blind pilot study comparing bioidentical 'natural' hormones to low-dose PremPro. Forty participants will be enrolled. The purpose of this study is to try to gather early information about safety when "natural" or bioidentical hormones are used during early menopause.

Effects of Angeliq® and Prempro™ 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 (Prempro™) 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).

more trials >>

Reports of Suspected Prempro (Conjugated Estrogens / Medroxyprogesterone) Side Effects

Breast Cancer Female (75)Hot Flush (56)Drug Ineffective (47)Depression (41)Breast Cancer (30)Anxiety (27)Feeling Abnormal (25)Headache (24)Insomnia (19)Malaise (18)more >>


PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 20 ratings/reviews, Prempro has an overall score of 7.60. The effectiveness score is 8.30 and the side effect score is 7.50. 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.

 

Prempro review by 62 year old female patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   Mild Side Effects
  
Treatment Info
Condition / reason:   menopause
Dosage & duration:   .0425 (dosage frequency: monthly) for the period of still on
Other conditions:   none
Other drugs taken:   none
  
Reported Results
Benefits:   reduce menopause related issues and improve quality of life. Hot flashes ceased, energy level increased, overall mood and memory retention were impacted in a positive way.
Side effects:   mild bloating, breast tenderness which did subside. Basically I did not have any major side effects and the mild ones decreased with usage.
Comments:   Prescription is to take one tablet by mouth once a day, preferably at the same time of day. Continue use until either want to no longer take or at advice of doctor. Continually discuss with physician.

 

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

See all Prempro reviews / ratings >>

Page last updated: 2013-02-10

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