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Delestrogen (Estradiol Valerate) - Summary

 
 



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, Malignant neoplasms, Endometrial cancer).

CARDIOVASCULAR AND OTHER RISKS

Estrogens and progestins should not be used for the prevention of cardiovascular disease. (See WARNINGS, Cardiovascular disorders).

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 oral conjugated estrogens (CE 0.625 mg) combined with medroxyprogesterone acetate (MPA 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 oral 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 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.

 

DELESTROGEN SUMMARY

DELESTROGEN® (estradiol valerate injection, USP) contains estradiol valerate, a long-acting estrogen in sterile oil solutions for intramuscular use. These solutions are clear, colorless to pale yellow. Formulations (per mL): 10 mg estradiol valerate in a vehicle containing 5 mg chlorobutanol (chloral derivative/preservative) and sesame oil; 20 mg estradiol valerate in a vehicle containing 224 mg benzyl benzoate, 20 mg benzyl alcohol (preservative), and castor oil; 40 mg estradiol valerate in a vehicle containing 447 mg benzyl benzoate, 20 mg benzyl alcohol, and castor oil.

DELESTROGEN (estradiol valerate injection, USP) 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.
  3. Treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure.
  4. Treatment of advanced androgen-dependent carcinoma of the prostate (for palliation only).

See all Delestrogen indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Delestrogen (Estradiol)

Effect of estradiol valerate on endometrium thickness during clomiphene citrate-stimulated ovulation. [2014]
CONCLUSIONS: We concluded that the addition of 6 mg/day EV following the CC

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

[Efficacy and safety of a combined oral contraceptive containing drospirenone 3 mg and ethinylestradiol 20 µg in the treatment of premenstrual dysphoric disorder: a randomized, double blind placebo-controlled study]. [Article in Chinese] [2014]
with placebo in reducing symptoms of premenstrual dysphoric disorder (PMDD)... CONCLUSIONS: YAZ could improve symptoms of PMDD better than placebo, while

Effects of tibolone or continuous combined oestradiol/norethisterone acetate on glucose and insulin metabolism. [2013]
insulin metabolism in postmenopausal women... CONCLUSIONS: Tibolone reduces insulin sensitivity. Healthy postmenopausal women

Impact of estradiol valerate/dienogest on work productivity and activities of daily living in women with heavy menstrual bleeding. [2013]
estradiol valerate/dienogest (E2V/DNG; Qlaira(®)/Natazia(®)) compared to placebo... CONCLUSIONS: E2V/DNG was shown to have a consistent positive impact on work

more studies >>

Reports of Suspected Delestrogen (Estradiol) Side Effects

Drug Ineffective FOR Unapproved Indication (2)Breast Cancer Female (2)Pruritus (1)Drug Ineffective (1)Hepatic Lesion (1)OFF Label USE (1)Depression (1)Breast Cancer (1)Condition Aggravated (1)Rash (1)more >>


PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 2 ratings/reviews, Delestrogen has an overall score of 10. The effectiveness score is 8 and the side effect score is 10. The scores are on ten point scale: 10 - best, 1 - worst.
 

Delestrogen review by 55 year old female patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   No Side Effects
  
Treatment Info
Condition / reason:   menopause/hysterectomy
Dosage & duration:   1 mg taken 1 per day for the period of 5 years
Other conditions:   high blood pressure
Other drugs taken:   atenolol
  
Reported Results
Benefits:   Significantly reduced symptoms of menopause, including eliminated all hot flashes (as long as the drug is being taken), reduces skin dryness that occurred after hysterectomy, and preserved sex drive. preserve sex drive
Side effects:   I am not aware of any side effects from this drug, I did not experience any.
Comments:   Doctor told me I could take as little as 1/4 tablet per day if I wanted. I take one per day and I am very happy with the results. If I accidentally skip one day, I know fairly soon that I have missed it because I get chills or start to have hot flashes.

 

Delestrogen review by 63 year old female patient

  Rating
Overall rating:  
Effectiveness:   Moderately Effective
Side effects:   No Side Effects
  
Treatment Info
Condition / reason:   total hysterectomy
Dosage & duration:   .5 mg taken daily for the period of 20 years
Other conditions:   P.A.T.
Other drugs taken:   metoprolot 25 mg
  
Reported Results
Benefits:   Keeping me from the effects of menopause.
Side effects:   I believe the benefits were to keep my skin soft, prevent sagging and wrinkles
Comments:   I was prescribed estrogen at the time of my total hysterectomy (due to increasing bleeding and starting periods every 2 weeks). I was becoming anemic from the bleeding and other procedures to stop this were not very successful. I was about 45 at the time and was given the option to begin HRT. Over the years I have been given decreasing levels and am currently at .5mg. Even with the negative info regarding prolonged HRT, I opted to continue. If you actually read the negative information, it was not related to estrogen, but rather to estrogen and progesterone in combination. Since then more articles have further clarified some of the mis-information. It may be a risk to continue long term HRT, but none of my doctors has really presented any solid reasoning to discontinue HRT.

See all Delestrogen reviews / ratings >>

Page last updated: 2015-08-10

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