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Femring (Estradiol Acetate Vaginal) - Summary

 
 



BOX WARNING

ESTROGENS INCREASE THE RISK OF ENDOMETRIAL CANCER

 

Close clinical surveillance of all women taking estrogens is important. Adequate diagnostic measures, including endometrial sampling when indicated, should be undertaken to rule out malignancy in all cases of undiagnosed persistent or recurring abnormal vaginal bleeding. There is no evidence that the use of “natural” estrogens results in a different endometrial risk profile than synthetic estrogens at equivalent estrogen doses. (See WARNINGS, 2. Malignant neoplasms, a. Endometrial cancer.)

 

CARDIOVASCULAR AND OTHER RISKS

 

Estrogens with or without progestins should not be used for the prevention of cardiovascular disease or dementia. (See CLINICAL STUDIES and WARNINGS, 1. Cardiovascular disorders and 3. Dementia.)

 

The estrogen-alone substudy of the Women's Health Initiative (WHI) reported increased risks of stroke and deep vein thrombosis (DVT) in postmenopausal women (50 to 79 years of age) during 6.8 years and 7.1 years, respectively, of treatment with oral conjugated estrogens (CE 0.625 mg) per day relative to placebo. (See CLINICAL STUDIES and WARNINGS, 1. Cardiovascular disorders.)

 

The estrogen-plus-progestin substudy of WHI 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 5.6 years of treatment with oral conjugated estrogens (CE 0.625 mg) combined with medroxyprogesterone acetate (MPA 2.5 mg) per day, relative to placebo. (See CLINICAL STUDIES and WARNINGS, 1. Cardiovascular disorders and 2. Malignant neoplasms, b. Breast cancer.)

 

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 5.2 years of treatment with CE 0.625 mg alone and during 4 years of treatment with 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 CLINICAL STUDIES and WARNINGS, 3. Dementia and PRECAUTIONS, I. Geriatric use.)

Other doses of oral conjugated estrogens with 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.

 

FEMRING SUMMARY

a. Stroke

Femring® (estradiol acetate vaginal ring) is an off-white, soft, flexible ring with a central core containing estradiol acetate. Femring is made of cured silicone elastomer composed of dimethyl polysiloxane silanol, silica (diatomaceous earth), normal propyl orthosilicate, stannous octoate; barium sulfate and estradiol acetate. The rings have the following dimensions: outer diameter 56 mm, cross-sectional diameter 7.6 mm, core diameter 2 mm.

Femring therapy is indicated in 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.

See all Femring indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Femring (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 Femring (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 VagifemŽ 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 ClimaraŽ 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 ClimaraŽ 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 >>


PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 3 ratings/reviews, Femring has an overall score of 7. The effectiveness score is 10 and the side effect score is 7.33. The scores are on ten point scale: 10 - best, 1 - worst.
 

Femring review by 55 year old female patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   No Side Effects
  
Treatment Info
Condition / reason:   Menopause
Dosage & duration:   0.10 mg/Day taken use one vaginally every 3 months for the period of 4-1/2 yrs still using
Other conditions:   None
Other drugs taken:   Provera 2.5 mg 1x monthly for 14 days
  
Reported Results
Benefits:   Do not experience hot flashes, night sweats, mood swings or insomnia due to menopause when using the Femring.
Side effects:   Use of Provera once monthly for 14 days caused excessive menstrual bleeding for 3 weeks at a time. Also experienced a localized skin irritation.
Comments:   Femring is inserted vaginally and replaced every 3 months. Hormones are released in daily doses. Provera was taken once monthly to slough uterus lining by forcing menstruation.

 

Femring review by 47 year old female patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   Extremely Severe Side Effects
  
Treatment Info
Condition / reason:   hysterectomy
Dosage & duration:   1.0 mg/day taken dosage administered daily for the period of 4 days
Other conditions:   serious blistery rash
Other drugs taken:   none
  
Reported Results
Benefits:   The Femring is great because you insert it and don't have to worry about remembering to take a pill or pills every day. This allows you freedom for the next three months, (90) days until your reorder a new ring. Also my insurance pays a good portion of the cost of the ring, whereas it did not cover the cost of bio-identical horomone treatments.
Side effects:   The bad thing about this certain dosage of the Femring was on the third day it seemed as though I was beginning to have vaginal irritation. The fourth day was obvious vaginal irritation with a blistery rash. Upon feeling and seeing this rash I removed the Femring and called my Dr.
Comments:   A lower dose Femring was prescribed, 0.05mg/day, which does a good job of returning my horomones levels to close to normal.

 

Femring review by 47 year old female patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   Extremely Severe Side Effects
  
Treatment Info
Condition / reason:   hysterectomy
Dosage & duration:   1.0 mg/day taken dosage administered daily for the period of 4 days
Other conditions:   serious blistery rash
Other drugs taken:   none
  
Reported Results
Benefits:   The Femring is great because you insert it and don't have to worry about remembering to take a pill or pills every day. This allows you freedom for the next three months, (90) days until your reorder a new ring. Also my insurance pays a good portion of the cost of the ring, whereas it did not cover the cost of bio-identical horomone treatments.
Side effects:   The bad thing about this certain dosage of the Femring was on the third day it seemed as though I was beginning to have vaginal irritation. The fourth day was obvious vaginal irritation with a blistery rash. Upon feeling and seeing this rash I removed the Femring and called my Dr.
Comments:   A lower dose Femring was prescribed, 0.05mg/day, which does a good job of returning my horomones levels to close to normal.

See all Femring reviews / ratings >>

Page last updated: 2013-02-10

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