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Vagifem (Estradiol Vaginal) - Summary

 
 



BOX WARNING

ESTROGENS HAVE BEEN REPORTED TO INCREASE THE RISK OF ENDOMETRIAL CARCINOMA.

Three independent, case controlled studies have reported an increased risk of endometrial cancer in post-menopausal women exposed to exogenous estrogens for more than one year. This risk was independent of the other known risk factors for endometrial cancer. These studies are further supported by the finding that incident rates of endometrial cancer have increased sharply since 1969 in eight different areas of the United States with population-based cancer-reporting systems, an increase which may be related to the rapidly expanding use of estrogens during the last decade.

The three case-controlled studies reported that the risk of endometrial cancer in estrogen users was about 4.5 to 13.9 times greater than in nonusers. The risk appears to depend on both duration of treatment and on estrogen dose.

In view of these findings, when estrogens are used for the treatment of menopausal symptoms, the lowest dose that will control symptoms should be utilized and medication should be discontinued as soon as possible. When prolonged treatment is medically indicated, the patient should be reassessed, on at least a semi-annual basis, to determine the need for continued therapy.

Close clinical surveillance of all women taking estrogens is important. In all cases of undiagnosed persistent or reoccurring abnormal vaginal bleeding, adequate diagnostic measures should be undertaken to rule out malignancy.

There is no evidence at present that “natural” estrogens are more or less hazardous than “synthetic” estrogens at equi-estrogenic doses.

 

VAGIFEM SUMMARY

VAGIFEM® (ESTRADIOL VAGINAL TABLETS)

VAGIFEM® (estradiol vaginal tablets) are small, white, film-coated tablets containing 25.8µg of estradiol hemihydrate equivalent to 25µg of estradiol.

VAGIFEM® is indicated for the treatment of atrophic vaginitis.


See all Vagifem indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Vagifem (Estradiol Vaginal)

[Impacts on the duration of vaginal bleeding and the levels of serum estradiol (E2) and progesterone (P) for patients of midtrimester induction of labor treated with moxibustion at Guanyuan (CV 4) and Shenque (CV 8)]. [2011.09]
OBJECTIVE: To verify the efficacy of moxibustion at Guanyuan (CV 4) and Shenque (CV 8) on the duration of vaginal bleeding for patients with midtrimester induction of labor and explore its mechanism... CONCLUSION: Moxibustion at Guanyuan (CV 4) and Shenque (CV 8) may shorten the duration of vaginal bleeding for patients with midtrimester induction of labor. Probably through the increase of serum E2 level and the decrease of P level, the uterine contraction is effectively enhanced and the excretion of placental villi and deciduas is promoted. As a result, endometrial repair occurs rapidly.

Estradiol 1 mg and drospirenone 2 mg as hormone replacement therapy in postmenopausal Chinese women. [2011.08]
OBJECTIVES: Drospirenone is a novel progestogen that, combined with 17beta-estradiol, reduces the frequency and severity of menopausal vasomotor symptoms (VMS) in different populations. This double-blind, multicenter study compared the efficacy, safety and tolerability of 2 mg drospirenone/1 mg estradiol (DRSP/E2) vs. placebo in Chinese postmenopausal women with moderate to severe VMS... CONCLUSIONS: Daily treatment of postmenopausal Chinese women with DRSP/E2 for 16 weeks significantly reduced the incidence of hot flushes and demonstrated advantages vs. placebo for other climacteric symptoms. These results indicate that DRSP/E2 is effective, safe and well tolerated in postmenopausal Chinese women.

[Evaluation the efficacy and safety of estradiol and drospirenone tablets in the treatment of menopausal symptoms among postmenopausal Chinese healthy women:a randomized, multi-center, double-blind, placebo-controlled clinical study]. [2011.05]
OBJECTIVE: To study the efficacy and safety of estradiol and drospirenone tablets (Angeliq) in treatment of menopausal symptoms among postmenopausal Chinese healthy women... CONCLUSION: Estradiol and drospirenone tablets which could effectively alleviate menopausal symptoms in postmenopausal Chinese healthy women is a novel hormone replacement therapy regimen with high safety and efficacy.

The comparison of hyaluronic acid vaginal tablets with estradiol vaginal tablets in the treatment of atrophic vaginitis: a randomized controlled trial. [2011.03]
OBJECTIVE: To compare the effectiveness of the vaginal tablets of hyaluronic acid and estrodiol for the treatment of atrophic vaginitis... CONCLUSION: Both treatments provided relief of vaginal symptoms, improved epithelial atrophy, decreased vaginal pH, and increased maturation of the vaginal epithelium. Those improvements were greater in group I. Hyaluronic acid vaginal tablets can be used in patients with atrophic vaginitis who do not want to or can not take local estrogen treatment.

[Evaluation the efficacy and safety of estradiol and drospirenone tablets in the treatment of menopausal symptoms among postmenopausal Chinese healthy women:a randomized, multi-center, double-blind, placebo-controlled clinical study]. [Article in Chinese] [2011]
healthy women... CONCLUSION: Estradiol and drospirenone tablets which could effectively alleviate

more studies >>

Clinical Trials Related to Vagifem (Estradiol Vaginal)

Vaginal Testosterone Cream vs ESTRING for Vaginal Dryness or Decreased Libido in Early Stage Breast Cancer Patients [Recruiting]
The purpose of this clinical research study is to determine whether the ESTRING or a special preparation of a testosterone cream inserted vaginally are safe for use in breast cancer patients. This study will also evaluate if either of these treatments can improve symptoms of vaginal dryness or decreased sexual interest that are related to your treatment for breast cancer.

Effect of Angeliq on Blood Pressure (BP) in Postmenopausal Hypertensive Women [Completed]
The objective of the study is to evaluate the effects of Angeliq on BP over a period of 8 weeks in postmenopausal women who may benefit from hormone replacement therapy (HRT) for the relief of vasomotor symptoms and who have hypertension.

Serum Estradiol Levels In Postmenopausal Women With Breast Cancer Receiving Adjuvant Aromatase Inhibitors and Vaginal Estrogen [Recruiting]
The purpose of this study is to see if Vagifem 10mcg is safe for women who have had breast cancer. Vagifem is an estrogen product. It is a tiny tablet that is inserted into the vagina. It relieves vaginal dryness. Women who have had breast cancer are usually told not to take estrogen. This is because estrogen use can lead to a breast cancer recurrence or a new primary breast cancer. It is unclear if the estrogen in Vagifem is only absorbed in the vagina. It may be absorbed into the blood stream for a short time and may cause a brief rise in your estrogen level. However, there is no clear evidence that this would cause any bad effects in patients with breast cancer. How much, if any, of these topical estrogens are absorbed through the vagina is not known. We also do not know what the impact is of low dose estrogen absorption on breast cancer outcomes. Also, the absorption should decrease as the mucus membranes are restored after estrogen exposure.

Effect of Estradiol+Drospirenone Versus Estradiol+MPA on Endothelial Function [Recruiting]
This study compares the effects of two common hormone medications on the heart and blood vessels of healthy post-menopausal women over the age of 45.

The study will take place over the course of about 5 months. Each subject will take two different medications over two six-week periods. They will be randomized at the beginning of the study to either estradiol+medroxyprogesterone acetate or estradiol+drospirenone for the first period, and will receive the other medication the second six-weeks of the study. At the very beginning of the study and at the end of each six-week treatment period, subjects will come to the hospital various tests including non-invasive blood vessel imaging tests, blood draws to test the levels of certain hormones in the body, an oral glucose tolerance test, a test to monitor renal blood flow, and 24-hour blood pressure monitoring. Between treatment periods, there will be a four-week medication-free washout period.

Evaluation of Adhesion Quality of a New Formulation of the Mylan Estradiol Transdermal System 0.025 mg/Day and Climara Transdermal System 0.025 mg/Day [Completed]
The primary objective of this study was to compare the adhesive quality of a new formulation of the Mylan Estradiol Transdermal System with that of Climara Transdermal System following a single system application in 80 healthy postmenopausal female volunteers. As a secondary objective, primary dermal irritation was assessed after removal of each transdermal system.

more trials >>

Reports of Suspected Vagifem (Estradiol Vaginal) Side Effects

Headache (7)Vomiting (7)Cerebral Haemorrhage (6)Fall (5)Extrasystoles (4)Snoring (4)Muscle Rigidity (4)Viith Nerve Paralysis (4)Speech Disorder (4)Facial Paresis (4)more >>


PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 6 ratings/reviews, Vagifem has an overall score of 7.67. The effectiveness score is 9.33 and the side effect score is 8.33. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
 

Vagifem review by 65 year old female patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   No Side Effects
  
Treatment Info
Condition / reason:   chronic urinary and yeast infections due to drynes
Dosage & duration:   25 mcg (dosage frequency: 1 x wk) for the period of 3 yrs and ongoing
Other conditions:   eczema
Other drugs taken:   none
  
Reported Results
Benefits:   Before the use of vagifem tablets, I had to endure a series of urinary infections after sometimes painful sexual intercourse. I also had painful cracks in mucoal lining of vulva due to aging and dryness. After beginning the use of this drug, I found that the ncreased mucous in vagina resolved both of these problems.
Side effects:   diminished disposable income
Comments:   Insert 1 tablet vaginally once weekly

 

Vagifem review by 59 year old female patient

  Rating
Overall rating:  
Effectiveness:   Considerably Effective
Side effects:   Mild Side Effects
  
Treatment Info
Condition / reason:   Postmenopausal Vaginal Atrophy
Dosage & duration:   25 (dosage frequency: twice a week) for the period of 9 months
Other conditions:   None
Other drugs taken:   Lexotan 6mg
  
Reported Results
Benefits:   Took all the terrible pain burning throbbing swelling paper cuts and constant Urination and pressure felt like id been hit inside was sore all the time even with out sex it was there constant pain around my Vaginal opening like a burn or sratch and inside too my genitals inner labia and clitoral hood have shrunk Ive been postmeno for 15 years Sex became almost normal except for entering Id say it worked 95% some days and 100% others
Side effects:   Not much BUT after 9 months my original symptoms seem to be returning Not slowly its happend almost overnight and I have no idea why?
Comments:   I took 1 every night for 3 weeks then every second night for 2 weeks then one twice a week

 

Vagifem review by 48 year old female patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   Severe Side Effects
  
Treatment Info
Condition / reason:   Vaginal Dryness and Urinary Tract Infections
Dosage & duration:   25mcg Twice a week (dosage frequency: 25mcg twice a week) for the period of 18 months
Other conditions:   None
Other drugs taken:   None
  
Reported Results
Benefits:   Using Vagifem for the first 18 months was brilliant. It increased lubrication and stopped the continual urethral soreness I had (and when passing water). It made everything feel normal again.
Side effects:   During the first 18 months I noticed slight water retention when I used it, and my hot flushes also came back to a lesser degree. Then recently I got a new batch of Vagifem, and I had a horrible allergic reaction - dizziness, sinus pain, severe palpitations and panic. My eyes, hands and feet went really puffy and it made my vagina and urinary tract really sore. I've since tried another new batch with the same problems. This is so disappointing. I've gone back to an older batch with no problems (except that I've now run out!). The manufacturers have changed something, and I wish they would change it back to the original formulation.
Comments:   25mcg Twice a week

See all Vagifem reviews / ratings >>

Page last updated: 2013-02-10

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