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Angeliq (Estradiol / Drospirenone) - Summary

 
 



BOX WARNING

Boxed Warnings

Estrogens with or without progestins should not be used for the prevention of cardiovascular disease or dementia. (See WARNINGS, Cardiovascular disorders and Dementia.) 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 equine estrogens (CE 0.625mg) combined with medroxyprogesterone acetate (MPA 2.5mg) relative to placebo (see CLINICAL PHARMACOLOGY, Clinical Studies and WARNINGS, Cardiovascular disorders and Malignant neoplasms, 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 conjugated estrogens alone and 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. (See CLINICAL PHARMACOLOGY, Clinical Studies, WARNINGS, Dementia and PRECAUTIONS, 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.

 

ANGELIQ SUMMARY

ANGELIQ TABLETS provide a hormone regimen consisting of film coated tablets each containing 0.5 mg of drospirenone and 1 mg of estradiol.

ANGELIQ is indicated in women who have a uterus for 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 Angeliq indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Angeliq (Estradiol / Drospirenone)

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.

Effects of estradiol-drospirenone hormone treatment on carotid artery intima-media thickness and vertigo/dizziness in postmenopausal women. [2011.05]
AIM: To investigate the effects of Angeliq on hormonal, metabolic, biochemical and cardiovascular profile, carotid intima-media thickness (CIMT) and vertigo/dizziness symptoms in postmenopausal women... CONCLUSIONS: Oral daily treatment with Angeliq reduces CIMT and climacteric complaints including vertigo/dizziness in postmenopausal women. They may relate to anti-androgenic and anti-mineralocorticoid effects of Angeliq, respectively.

[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

Angeliq versus Activelle in normotensive postmenopausal women: a prospective, randomized pilot study. [2009.07]
OBJECTIVE: The aim of this study was to compare, in normotensive postmenopausal women, the effects of drospirenone/estradiol and norethisterone acetate/estradiol on blood pressure and other surrogate markers of cerebrovascular and cardiovascular risk... CONCLUSIONS: A 6-month hormone therapy with drospirenone/estradiol or norethisterone acetate/estradiol is equally effective and does not seem to alter the surrogate markers of cardiovascular and cerebrovascular risk.

more studies >>

Clinical Trials Related to Angeliq (Estradiol / Drospirenone)

Angeliq Regulatory Post Marketing Surveillance [Recruiting]

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.

A Study to Examine the Safety and Efficacy Of Drospirenone and Ethinyl Estradiol (YAZ) Compared With Placebo In The Treatment Of Moderate Truncal Acne Vulgaris [Recruiting]
The purpose of this study is to find out if taking a birth control pill, YAZ, is safe and effective for treating acne on the trunk (the main part of the body that does not include the arms, legs, and head).

Acne vulgaris is a very common skin disorder. It is caused when oil-producing skin glands (sebaceous glands) become plugged. The plug can cause blackheads, whiteheads, pimples, and cysts on the face, neck, upper chest, and upper back.

YAZ is a combination birth control pill. A "combination" pill means that it is made up of more than one major ingredient. Nearly all birth control pills are made up of a combination of estrogen and progestin hormones. Estrogens are steroid hormones produced by the ovaries responsible for the typical female features. Progestins are steroid hormones produced by the ovary and placenta responsible for making the uterus fit for pregnancy. YAZ also contains an estrogen called ethinyl estradiol, and a progestin called drospirenone. People who develop acne have sebaceous glands that are over-stimulated (that is, the sebaceous glands have increased activity) by male sex hormones (androgens). The progestin in YAZ blocks the male sex hormones (androgens) that cause acne.

The study drug being used in this study is called YAZ. It has been approved by the U. S. Food and Drug Administration (FDA) to treat moderate acne in women who want an oral contraceptive for birth control.

In this study, YAZ will be compared to a placebo for safety and effectiveness. A placebo looks like the study drug but contains no active drug (like a sugar pill). We use placebos in research studies to learn if the effects seen in research subjects are truly from the study drug or from other reasons.

YAZ Post-marketing Surveillance in Japan [Recruiting]
This study is a regulatory post marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received YAZ for dysmenorrhea. The objective of this study is to assess safety and efficacy of using YAZ in clinical practice. A total 3,000 patients will be recruited and followed 3 years since starting YAZ administration.

Regulatory Post Marketing Surveillance Study on YAZ [Recruiting]

more trials >>

Reports of Suspected Angeliq (Estradiol / Drospirenone) Side Effects

Skin Exfoliation (2)Gastric Ulcer (2)Hot Flush (2)Vomiting (2)Rash (2)Weight Decreased (1)Breast Enlargement (1)Flatulence (1)Headache (1)Constipation (1)more >>


PATIENT REVIEWS / RATINGS / COMMENTS

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

Angeliq review by 67 year old female patient

  Rating
Overall rating:  
Effectiveness:   Considerably Effective
Side effects:   No Side Effects
  
Treatment Info
Condition / reason:   menopausal symptoms - hot flashes, sleep disturban
Dosage & duration:   0.5mg drosperanone/1 mg estradiol taken daily for the period of 1.5 years
Other conditions:   none
Other drugs taken:   no RX - only multi vitamin/mineral supplement and antioxidant
  
Reported Results
Benefits:   Markedly decreased hot flashes, which allowed for better sleep. Reversal of vaginal atrophy symptoms and vaginal dryness, and the accompanying itching and irritation.
Side effects:   I have not experienced any side effects to date.
Comments:   According to my doctor, I am one of the small percentage of women who become more symptomatic as time goes by after menopause. I had stopped hormone replacement therapy after the Women's Health Initiative Study as a result of the negative findings of the Study. Over a period of several years, I was increasingly bothered by the disturbed sleep resulting from hot flashes and the vaginal discomforts mentioned above, and so reluctantly decided to resume taking hormones. The doctor stated that Angeliq provided a low dose and that the progestin was closer to that which our body naturally produces. I took it daily for about a year. For the last six months, I have, with the doctor's approval, decreased use from every night to five nights during the week and none on the week-end. I have not suffered any negative results from the decrease.

 

Angeliq review by 42 year old female patient

  Rating
Overall rating:  
Effectiveness:   Considerably Effective
Side effects:   No Side Effects
  
Treatment Info
Condition / reason:   Menopause for 2 years, first hormone pill taken
Dosage & duration:   0.5mg taken 1 x day for the period of 1 year
Other conditions:   none
Other drugs taken:   none
  
Reported Results
Benefits:   Angeliq did eliminate the night sweats and kept the hot flashes to a mininum. I have had severe vaginal dryness (even tearing) and a host of infections (yeast & bacterial). I remain a bit irritated and I have NO sex drive.
Side effects:   No real side effects except infections (which the doctor said was Normal???).
Comments:   I pill daily for a year.

See all Angeliq reviews / ratings >>

Page last updated: 2013-02-10

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