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Prempro (Conjugated Estrogens / Medroxyprogesterone) - Summary

 
 



WARNING: CARDIOVASCULAR DISORDERS, BREAST CANCER, ENDOMETRIAL CANCER and PROBABLE DEMENTIA

Estrogen Plus Progestin Therapy

Cardiovascular Disorders and Probable Dementia

Estrogen plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia [see Warnings and Precautions (5.1, 5.3), and Clinical Studies (14.6, 14.7)].

The Women’s Health Initiative (WHI) estrogen plus progestin substudy reported an increased risk of deep vein thrombosis (DVT), pulmonary embolism, stroke and myocardial infarction in postmenopausal women (50 to 79 years of age) during 5.6 years of treatment with daily oral conjugated estrogen (CE) [0.625 mg] combined with medroxyprogesterone acetate (MPA) [2.5 mg], relative to placebo [see Warnings and Precautions and Clinical Studies].

The WHI Memory Study (WHIMS) estrogen plus progestin ancillary study of the WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with daily CE (0.625 mg) combined with MPA (2.5 mg), relative to placebo. It is unknown whether this finding applies to younger postmenopausal women [see Warnings and Precautions Use in Specific Populations (8.5), and Clinical Studies].

Breast Cancer

The WHI estrogen plus progestin substudy demonstrated an increased risk of invasive breast cancer [see Warnings and Precautions and Clinical Studies].

In the absence of comparable data, these risks should be assumed to be similar for other doses of CE and MPA and other combinations and dosage forms of estrogens and progestins.

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.

Estrogen-Alone Therapy

Endometrial Cancer

There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens. Adding a progestin to estrogen therapy has been shown to reduce the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer. Adequate diagnostic measures, including directed or random endometrial sampling when indicated, should be undertaken to rule out malignancy in postmenopausal women with undiagnosed persistent or recurring abnormal genital bleeding [see Warnings and Precautions ].

Cardiovascular Disorders and Probable Dementia

Estrogen-alone therapy should not be used for the prevention of cardiovascular disease or dementia [see Warnings and Precautions (5.1, 5.3), and Clinical Studies (14.6, 14.7)].

The WHI estrogen-alone substudy reported increased risks of stroke and deep vein thrombosis (DVT) in postmenopausal women (50 to 79 years of age) during 7.1 years of treatment with daily oral CE (0.625 mg), relative to placebo [see Warnings and Precautions and Clinical Studies].

The WHIMS estrogen-alone ancillary study of WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 5.2 years of treatment with daily CE (0.625 mg)-alone, relative to placebo. It is unknown whether this finding applies to younger postmenopausal women [see Warnings and Precautions Use in Specific Populations (8.5), and Clinical Studies].

In the absence of comparable data, these risks should be assumed to be similar for other doses of CE and other dosage forms of estrogens.

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

Premarin (conjugated estrogens tablets, USP) for oral administration contains a mixture obtained exclusively from natural sources, occurring as the sodium salts of water-soluble estrogen sulfates blended to represent the average composition of material derived from pregnant mares' urine. It is a mixture of sodium estrone sulfate and sodium equilin sulfate. It contains as concomitant components, as sodium sulfate conjugates, 17 α-dihydroequilin, 17 α-estradiol and 17 β-dihydroequilin. Medroxyprogesterone acetate is a derivative of progesterone.

PREMPRO (ESTROGENS, CONJUGATED/MEDROXYPROGESTERONE) is indicated for the following:

Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause

Treatment of Moderate to Severe Vulvar and Vaginal Atrophy due to Menopause

Prevention of Postmenopausal Osteoporosis


See all Prempro indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Prempro (Conjugated Estrogens / Medroxyprogesterone)

Effects of bazedoxifene/conjugated estrogens on the endometrium and bone: a randomized trial. [2014]
alone, hormone therapy, and placebo (PBO)... CONCLUSIONS: BZA/CE showed low rates of endometrial hyperplasia and improved

Sleep parameters and health-related quality of life with bazedoxifene/conjugated estrogens: a randomized trial. [2014]
and active-controlled phase 3 trial... CONCLUSIONS: Symptomatic postmenopausal women who are treated with BZA/CE for 1

Breast effects of bazedoxifene-conjugated estrogens: a randomized controlled trial. [2013]
and active-controlled phase 3 study... CONCLUSION: Bazedoxifene 20 mg and conjugated estrogens 0.45 and 0.625 mg did not

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.

more studies >>

Clinical Trials Related to Prempro (Conjugated Estrogens / Medroxyprogesterone)

Effects of Angeliq and Prempro on Blood Pressure and Sodium Sensitivity in Postmenopausal Women With Prehypertension [Completed]
The main purpose of this study is to compare the effects of treatment of two different formulations of Angeliq® and Prempro on blood pressure in post-menopausal women with prehypertension.

Bioidentical 'Natural' Hormone Evaluation in Early Menopause [Completed]
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.

Study Comparing Premarin®/MPA, PREMPRO® and Provera® in Healthy Postmenopausal Women [Completed]
The purpose of the study is to evaluate the safety and efficacy of new tablet formulations of Premarin®/medroxyprogesterone (MPA).

Study Comparing Four New Formulations for Premarin in Healthy Postmenopausal Women [Completed]

The Women's Health Initiative Memory Study (The WHIMS Study) [Completed]
Excessive memory decline or dementia affects an increasing number of women as they become older. The frequency of dementia doubles every 5 years beginning at age 60, making the discovery of ways to prevent or slow the disease imperative. Previous studies have indicated that changes in memory may be associated with the female hormonal decline that occurs after menopause, but more research is needed to establish the link between menopause and poorer memory function. It is believed that taking the female hormones estrogen and/or progesterone may help improve women's health by protecting against memory decline. This study will evaluate the effects of female hormone replacement therapy (HRT) on the development and progression of memory loss in older women enrolled in the Women's Health Initiative (WHI) study.

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: 2014-11-30

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