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.
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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.
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NEWS HIGHLIGHTS
Published Studies Related to Angeliq (Estradiol / Drospirenone)
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.
Comparison of the effects of hormone therapy regimens, oral and vaginal estradiol, estradiol + drospirenone and tibolone, on sexual function in healthy postmenopausal women. [2008.01]
INTRODUCTION: Sexual dysfunction is more prevalent in postmenopausal women. AIMS: To prospectively evaluate and compare the effects of hormone therapy (HT) regimens, oral and vaginal estradiol, estradiol + drospirenone and tibolone, on sexual function in healthy postmenopausal women... CONCLUSIONS: HT provided significant improvement in sexual function compared to women receiving no treatment, and therefore, HT regimens should be suggested for improvement in sexual functioning of postmenopausal women.
Effect of estradiol-drospirenone hormone treatment on myocardial perfusion reserve in postmenopausal women with angina pectoris. [2007.06.15]
Recent randomized clinical studies failed to show cardiovascular protection with postmenopausal hormone therapy (HT), instead raising widespread concerns about possible increased cardiovascular risk. However, these studies primarily assessed the combination of conjugated equine estrogen and medroxyprogesterone acetate, which is suspected to abolish the beneficial effects of estrogen on the microcirculation...
Efficacy of a new oral contraceptive containing drospirenone and ethinyl estradiol in the long-term treatment of hirsutism. [2006.02]
OBJECTIVE: This study represents long term clinical and biochemical results and the response of different body parts to medical therapy with oral ethinyl estradiol/drospirenone combination in hirsute patients with or without polycystic ovary syndrome (PCOS)... The beneficial effect is most obvious after six cycles and continues thereafter at a slower rate.
Angeliq versus Activelle in normotensive postmenopausal women: a prospective, randomized pilot study. [2009.02.03]
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.
Clinical Trials Related to Angeliq (Estradiol / Drospirenone)
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.
Yasmin 20 Cycle Control - Yasmin 20 Versus Mercilon in Healthy Female Volunteers [Completed]
Regulatory Post Marketing Surveillance Study on YAZ [Recruiting]
A Study to Examine the Safety and Efficacy of Drospirenone and Ethinyl Estradiol (YAZ) Compared With Placebo In The Treatment Of Hidradenitis Suppurativa [Recruiting]
The purpose of this study is to find out if taking a birth control pill, YAZ, is safe and
effective for treating hidradenitis suppurativa. Hidradenitis suppurativa (HS) is a chronic
(long lasting) skin disorder that mostly affects the armpits and groin area. It appears as
blackheads and one or more red, tender bumps that may enlarge, break open, and drain pus.
Scarring may result after several attacks of the disease.
The exact cause of HS isn't known. However, it is believed that the plugging of hair
follicles and bacterial infection that occur in acne also occur in HS. Many of the
medications used for treating acne are also used for HS. However, none of the medications
are consistently effective.
YAZ is a combination birth control pill. Nearly all birth control pills are made up of a
combination of estrogen and progestin hormones. YAZ contains ethinyl estradiol (an estrogen)
and drospirenone (a progestin). People who develop acne have sebaceous glands that are
over-stimulated by male sex hormones (androgens). Sebaceous glands secrete an oily substance
into a hair follicle to lubricate hair or skin. The progestin in YAZ actually blocks the
male sex hormones (androgens) that cause acne. Hormones seem to play a role in HS as the
condition occurs after puberty. It affects more women than men and HS often gets worse
around the time a women has her menstrual period.
YAZ has been approved by the U. S. Food and Drug Administration (FDA) to treat moderate acne
in women who desire an oral contraceptive for birth control.
This study uses a placebo. A placebo looks like the study drug but contains no active drug.
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.
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.
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 1 ratings/reviews, Angeliq has an overall score of 9. 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. |
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Page last updated: 2009-10-20
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