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Vagifem (Estradiol Vaginal) - Summary

 
 



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

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,(5.4), and Clinical Studies, ].

The Women's Health Initiative (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 conjugated estrogens (CE) [0.625 mg], relative to placebo [ see Warnings and Precautions, and Clinical Studies].

The WHI Memory Study (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, 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.

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, and Clinical Studies, ].

The WHI estrogen plus progestin substudy reported increased risks of 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 CE (0.625 mg) combined with medroxyprogesterone acetate (MPA) [2.5 mg], relative to placebo [ see Warnings and Precautions, and Clinical Studies ].

The 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, and Clinical Studies].

Breast Cancer

The WHI estrogen plus progestin substudy also 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.

 

VAGIFEM SUMMARY

Vagifem 10 mcg (estradiol vaginal tablets) are small, white, film-coated tablets containing 10.3 mcg of estradiol hemihydrate equivalent to 10 mcg of estradiol. Vagifem 25 mcg (estradiol vaginal tablets) are small, white, film-coated tablets containing 25.8 mcg of estradiol hemihydrate equivalent to 25 mcg of estradiol. Each tablet of Vagifem 10 mcg and 25 mcg contains the following excipients: hypromellose, lactose monohydrate, maize starch and magnesium stearate. The film coating contains hypromellose and polyethylene glycol. Each Vagifem tablet is 6 mm in diameter and is placed in a disposable applicator. Each tablet-filled applicator is packaged separately in a blister pack. Vagifem tablets are used intravaginally. When the tablet comes in contact with the vaginal mucosa, estradiol is released into the vagina.

VAGIFEM (ESTRADIOL) is indicated for the following:

Treatment of Atrophic Vaginitis due to Menopause


See all Vagifem indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Vagifem (Estradiol Vaginal)

Sexual function in women on estradiol or venlafaxine for hot flushes: a randomized controlled trial. [2014]
estradiol or venlafaxine for hot flushes... CONCLUSION: Overall sexual function among nondepressed midlife women experiencing

[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.

more studies >>

Clinical Trials Related to Vagifem (Estradiol Vaginal)

A Comparison of Estradiol Vaginal Cream to Estrace´┐Ż Cream in 350 Postmenopausal Females With Atrophic Vaginitis [Completed]

Study to Evaluate the Safety and Bioequivalence of Estradiol Vaginal Inserts, 10 mcg and Vagifem´┐Ż 10 mcg and Compare to Placebo [Completed]
The purpose of this study is to compare the safety and efficacy of generic Estradiol Vaginal Inserts, USP 10 mcg to the reference product Vagifem« 10 mcg and to determined whether the efficacy of each of the 2 active treatments is superior to that of the placebo.

Efficacy and Safety Of Spil's Estradiol Vaginal Tablet [Terminated]
Estradiol vaginal tablet is a tablet which hydrates upon contact with moisture, releasing 17▀-estradiol. The estradiol in estradiol vaginal tablet is chemically and biologically identical to the endogenous human estradiol and is therefore classified as a human estrogen. The purpose of this study is to demonstrate clinical endpoint bioequivalence of SPIL's Estradiol vaginal tablet, 10mcg estradiol to the reference listed drug (Vagifem«)which is approved and marketed in the US.

Preventive Effect of Treatment With Estradiol Vaginal Tablets on Recurrent Urinary Tract Infections in Post-menopausal Women [Terminated]
This trial is conducted in Europe. The aim of this trial is to investigate the preventive effect of treatment with estradiol vaginal tablets on recurrent urinary tract infections (RUTI) in post-menopausal women with signs of urogenital ageing (UGA).

Evaluate Long-Term Safety and Efficacy WC3011 [Completed]
This is an open-label extension study evaluating the long-term safety and efficacy of WC3011 in non-hysterectomized, healthy, postmenopausal women with vulvovaginal atrophy.

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: 2014-11-30

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