Premarin (Conjugated Estrogens) - Summary

PREMARIN SUMMARY

PREMARIN^® (conjugated estrogens tablets, USP) for oral administration contains a mixture of conjugated estrogens obtained exclusively from natural sources, occurring as the sodium salts of water-soluble estrogen sulfates blended to represent the average composition of material derived from pregnant mares' urine. It is a mixture of sodium estrone sulfate and sodium equilin sulfate. It contains as concomitant components, as sodium sulfate conjugates, 17α-dihydroequilin, 17α-estradiol, and 17β-dihydroequilin.

PREMARIN therapy is indicated in the:

1. Treatment of moderate to severe vasomotor symptoms due to menopause.
2. Treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to 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 breast cancer (for palliation only) in appropriately selected women and men with metastatic disease.
5. Treatment of advanced androgen-dependent carcinoma of the prostate (for palliation only).
6. Prevention of postmenopausal osteoporosis. When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and for whom non-estrogen medications are not considered to be appropriate. (See CLINICAL STUDIES.)

   The mainstays for decreasing the risk of postmenopausal osteoporosis are weight-bearing exercise, adequate calcium and vitamin D intake, and when indicated, pharmacologic therapy. Postmenopausal women require an average of 1500 mg/day of elemental calcium. Therefore, when not contraindicated, calcium supplementation may be helpful for women with suboptimal dietary intake. Vitamin D supplementation of 400-800 IU/day may also be required to ensure adequate daily intake in postmenopausal women.

NEWS HIGHLIGHTS

Published Studies Related to Premarin (Conjugated Estrogens)

Effects of bazedoxifene/conjugated estrogens on the endometrium and bone: a randomized trial. [2014]
alone, hormone therapy, and placebo (PBO)... CONCLUSIONS: BZA/CE showed low rates of endometrial hyperplasia and improved

Sleep parameters and health-related quality of life with bazedoxifene/conjugated estrogens: a randomized trial. [2014]
and active-controlled phase 3 trial... CONCLUSIONS: Symptomatic postmenopausal women who are treated with BZA/CE for 1

Menopause-specific quality of life across varying menopausal populations with conjugated estrogens/bazedoxifene. [2014]
types in phase 3 clinical trials... CONCLUSIONS: CE/BZA significantly improved overall and vasomotor-related MSQOL

Breast effects of bazedoxifene-conjugated estrogens: a randomized controlled trial. [2013]
and active-controlled phase 3 study... CONCLUSION: Bazedoxifene 20 mg and conjugated estrogens 0.45 and 0.625 mg did not

Health outcomes after stopping conjugated equine estrogens among postmenopausal women with prior hysterectomy: a randomized controlled trial. [2011.04.06]
CONTEXT: The Women's Health Initiative Estrogen-Alone Trial was stopped early after a mean of 7.1 years of follow-up because of an increased risk of stroke and little likelihood of altering the balance of risk to benefit by the planned trial termination date. Postintervention health outcomes have not been reported. OBJECTIVE: To examine health outcomes associated with randomization to treatment with conjugated equine estrogens (CEE) among women with prior hysterectomy after a mean of 10.7 years of follow-up through August 2009... CONCLUSIONS: Among postmenopausal women with prior hysterectomy followed up for 10.7 years, CEE use for a median of 5.9 years was not associated with an increased or decreased risk of CHD, deep vein thrombosis, stroke, hip fracture, colorectal cancer, or total mortality. A decreased risk of breast cancer persisted. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00000611.

more studies >>

Clinical Trials Related to Premarin (Conjugated Estrogens)

Two Doses of Conjugated Estrogen (Premarin) in Patients With Androgen-Independent Prostate Cancer [Completed]
The purpose of this study is to see if Premarin is useful against androgen-independent prostate cancer and to help understand how drugs such as Premarin may work.

A Study To Compare The Amount Of Premarin Components That Is Absorbed Into The Blood Of Japanese Healthy Postmenopausal Women Following Oral Administration Of Two Different Tablets Of Premarin Under Fast and Fed Conditions. [Completed]
The purpose of this study is to assess the bioequivalence and food effect for a new Premarin formulation compared with a Premarin reference tablet in Japanese healthy postmenopausal women.

Study Comparing 3 New Formulations of Premarin® 0.625 mg/MPA 2.5 mg With a Reference Formulation [Completed]
The purpose of this trial is to determine the equivalence of 3 new formulations of a Premarin®/medroxyprogesterone acetate (MPA) combination tablet to the currently marketed dosage form (Prempro® [TM]). This study will be performed in healthy postmenopausal women. Each subject will participate in the study for approximately 14 weeks, including a screening evaluation within 3 weeks before the study, and four, 6-day, 5-night inpatient periods with at least a 21-day washout interval between each dose administration.

Study Comparing Premarin®/MPA, PREMPRO® and Provera® in Healthy Postmenopausal Women [Completed]
The purpose of the study is to evaluate the safety and efficacy of new tablet formulations of Premarin®/medroxyprogesterone (MPA).

Beneficial Effects of Oral Premarin Estrogen Replacement Therapy Assessed by Human Genome Array [Completed]
The purpose of this study is to assess the immunological status of patients using Premarin. Premarin use is associated with an enhanced immune status, and possibly even some anti-cancer effect. The researchers will compare the use of Premarin with those not using hormone replacement therapy (HRT) to track the effects of Premarin in reducing the risk of infection and swelling.

more trials >>

Reports of Suspected Premarin (Conjugated Estrogens) Side Effects

Hot Flush (142),  Drug Ineffective (123),  Breast Cancer Female (92),  Headache (77),  Feeling Abnormal (69),  Depression (65),  Malaise (63),  Vulvovaginal Burning Sensation (49),  Pain (47),  Insomnia (44), more >>

PATIENT REVIEWS / RATINGS / COMMENTS

Premarin review by 62 year old female patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		Mild Side Effects
		Treatment Info
Condition / reason:		hormone replacement therapy
Dosage & duration:		.625 mg taken once daily for the period of 10 years
Other conditions:		migraines
Other drugs taken:		zomig
		Reported Results
Benefits:		I had a complete hysterectomy at age 52 and started HRT to avoid the immediate menapause which occurred right after surgery. Unfortunately the hospital staff put me on the estrogen patch which did not work and I was miserable the first couple of nights with severe hot flashes and poor sleep waking up often with soaked clothes and the sensation of itching everywhere during the day. Once my GYN doc changed me over to Premarin .625mg everything adverse disappeared and I enjoyed no menapausal hot flashes,mood swings, loss of sleep, vaginal dryness and my skin benefited as well, no lines or wrinkles and good elasticity.
Side effects:		may have made migraines better or worse..don't know for sure hyperpigmentation on neck
Comments:		one tablet per day .625mg-took for ten years-yearly mamograms with no problems

Premarin review by 54 year old female patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		Mild Side Effects
		Treatment Info
Condition / reason:		partial hysterectomy
Dosage & duration:		.045 mg taken 1 time daily for the period of 2 years
Other conditions:		none
Other drugs taken:		none
		Reported Results
Benefits:		Had to have a partial hysterectomy due to endometreosis. After the surgery began experiencing hot flashes on a very frequent basis - approximately 1-2 times per hour. My gynecologist prescribed Premarin .030mg. Since then I have moved up to the .045 mg dosage which I take once a day. For the most part, this relieves my symptoms even though I wake up at night on occasion with a night sweat.
Side effects:		periodic headaches
Comments:		take once daily for relief of menopause symptoms

Premarin review by care giver of 76 year old female patient
		Rating
Overall rating:
Effectiveness:		Moderately Effective
Side effects:		Extremely Severe Side Effects
		Treatment Info
Condition / reason:		hrt hysterectomy
Dosage & duration:		0.625 (dosage frequency: daily) for the period of 40 years
Other conditions:		none
Other drugs taken:		none
		Reported Results
Benefits:		stopped hot flashes
Side effects:		breast lumps requiring surgery three times stroke cancer requiring surgery, three separate chemo therapies
Comments:		My grand mom was prescribed Premarin after her uterus was removed at age 34. She was a smoker with high blood pressure. Her doctor was aware of her smoking and blood pressure. At one point in her hrt therapy she was injecting Premarin per doctors orders. Now at age 76, grand mom continues to take Premarin because she was told by her doctor that it is the fountain of youth. She is very vain and does not care if this drug kills her as long as she looks young. She looks and acts older than her actual age. The risk do not out weigh the benefit. HRT should only be used to ease a woman into menopause. Grand mom still has hot flashes after 40 years of HRT. Had she not taken HRT she would be through menopause and never have suffered the stroke or cancers which took several years of her life away.