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Ogen (Estropipate) - Summary

 
 



WARNINGS

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 result in a different endometrial risk profile than "synthetic" estrogens at equivalent estrogen doses. (See WARNINGS, Malignant neoplasms, Endometrial cancer.)

CARDIOVASCULAR AND OTHER RISKS

Estrogens with and without 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.)

 

OGEN SUMMARY

OGEN®
estropipate tablets, USP

OGEN (estropipate tablets), (formerly piperazine estrone sulfate), is a natural estrogenic substance prepared from purified crystalline estrone, solubilized as the sulfate and stabilized with piperazine. It is appreciably soluble in water and has almost no odor or taste — properties which are ideally suited for oral administration. The amount of piperazine in OGEN is not sufficient to exert a pharmacological action. Its addition ensures solubility, stability, and uniform potency of the estrone sulfate.

OGEN is indicated in the:

  1. Treatment of moderate to severe vasomotor symptoms associated with the menopause.
  2. Treatment of moderate to severe symptoms of vulval 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. 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.
    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.

See all Ogen indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Ogen (Estropipate)

Enlarged Left Atrium Points to AF in Cryptogenic Stroke
Source: Medscape Emergency Medicine Headlines [2014.11.18]
An enlarged left atrium, even without atrial fibrillation upon presentation of stroke, points to the possibility of a cardioembolic cause, a study reports. Paroxysmal atrial fibrillation should be suspected.
Medscape Medical News

Researchers identify estrogen's role in regulating heart disease risks
Source: Cholesterol News From Medical News Today [2014.11.18]
What makes some women more susceptible to heart disease than others?To help answer that question, researchers at Western University's Robarts Research Institute have identified that an estrogen...

Researchers find elevated carcinogen markers in car passengers of smokers
Source: Smoking / Quit Smoking News From Medical News Today [2014.11.18]
Nonsmokers sitting in an automobile with a smoker for one hour had markers of significantly increased levels of carcinogens and other toxins in their urine, indicating that secondhand smoke in motor...

Western researchers identify estrogen's role in regulating two of the most common risk factors for heart disease in women
Source: Endocrinology News From Medical News Today [2014.11.17]
To help answer that question, researchers at Western University have identified that an estrogen receptor, previously shown to regulate blood pressure in women, also plays an important role in...

Estrogen May Protect Heart by Inhibiting Mineralocorticoid (CME/CE)
Source: MedPage Today OB/Gyn [2014.11.09]
(MedPage Today) -- In vitro study may explain estrogen's cardioprotective effect

more news >>

Published Studies Related to Ogen (Estropipate)

A bi-functional anti-thrombosis protein containing both direct-acting fibrin(ogen)olytic and plasminogen-activating activities. [2011.03.14]
CONCLUSIONS: The study identified novel thrombolytic agent with prospecting clinical potential because of its bi-functional merits containing both plasmin- and PA-like activities and unique pharmacological kinetics in vivo.

A T cell-binding fragment of fibrinogen can prevent autoimmunity. [2010.06]
The C-terminal domain of the fibrinogen gamma chain (gammaC) has been shown to bind to the integrins alphaIIbbeta3, alphaMbeta2 and alphaVbeta3...

Suppression of the barley uroporphyrinogen III synthase gene by a Ds activation tagging element generates developmental photosensitivity. [2009.03]
Chlorophyll production involves the synthesis of photoreactive intermediates that, when in excess, are toxic due to the production of reactive oxygen species (ROS). A novel, activation-tagged barley (Hordeum vulgare) mutant is described that results from antisense suppression of a uroporphyrinogen III synthase (Uros) gene, the product of which catalyzes the sixth step in the synthesis of chlorophyll and heme.

Protective effects of plasmin(ogen) in a mouse model of Staphylococcus aureus-induced arthritis. [2008.03]
OBJECTIVE: To assess the functional roles of plasmin in a murine model of Staphylococcus aureus-induced bacterial arthritis... CONCLUSION: Our findings indicate that plasmin plays a pluripotent role in protecting against S aureus-induced arthritis by activating inflammatory cells, killing bacteria, removing necrotic tissue, and enhancing cytokine expression.

Fibrin(ogen) exacerbates inflammatory joint disease through a mechanism linked to the integrin alphaMbeta2 binding motif. [2007.11]
Fibrin deposition within joints is a prominent feature of arthritis, but the precise contribution of fibrin(ogen) to inflammatory events that cause debilitating joint damage remains unknown. To determine the importance of fibrin(ogen) in arthritis, gene-targeted mice either deficient in fibrinogen (Fib-) or expressing mutant forms of fibrinogen, lacking the leukocyte receptor integrin alphaMbeta2 binding motif (Fibgamma390-396A) or the alphaIIbbeta3 platelet integrin-binding motif (FibgammaDelta5), were challenged with collagen-induced arthritis (CIA)...

more studies >>

Clinical Trials Related to Ogen (Estropipate)

Phase 2a Randomized, Double-Blind Study of Oleoyl-Estrone in Male Morbidly Obese Adults [Active, not recruiting]

Phase 2a Obesity Study of Oral Doses of Oleoyl-Estrone (MP-101) [Active, not recruiting]
The purpose of this study is to evaluate the safety, preliminary efficacy, and pharmacokinetics of two 14-day cycles of escalating oral doses of MP 101 in 100 obese adult subjects.

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. [Recruiting]
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.

Evaluation of Efficacy/Safety of EVE-PMS Skin Test Panel [Recruiting]
The EVE-PMS technology is intended for determination of intolerance or sensitivity to sex hormones, among women suffering from severe PreMenstrual Syndrome (PMS).

The system includes skin testing panel for identification of hormones to which the patients might be sensitive. Tests are applied close to the ovulation period and the skin reaction is examined in 20 minutes, 48 hours and daily during the following month. Results of skin tests and patient's history will determine the value of EVE-PMS Skin-Test Panel as a diagnostic tool for severe PMS patients.

Evaluation of Safety/Efficacy of Diagnostic Skin Test Panel and Desensitization Hormone Kit for Treatment of Premenstrual Syndrome (PMS) [Recruiting]
The EVE-PMS technology is intended for determination of intolerance or sensitivity to sex hormones, among women suffering from severe PreMenstrual Syndrome (PMS) and desensitizes them with the relevant sex hormones in order to reduce PMS symptoms.

The system includes skin testing panel for identification of hormones to which the patients might be sensitive. Tests are applied close to the ovulation period and the skin reaction is examined in 20 minutes, 48 hours and daily during the following month. Results of skin tests and patient's history will determine the eligibility of the patients to enter a desensitization protocol.

During the desensitization period hormones to which the patient were found sensitive to, are injected intradermally three times (once a month) within the luteal phase in increasing doses. The end-point of the study is a statistically significant decrease, or elimination of PMS symptoms, compared to a solvent group.

more trials >>

Reports of Suspected Ogen (Estropipate) Side Effects

Breast Cancer Female (6)Depression (5)Abdominal Pain (3)Fibrocystic Breast Disease (3)Dyspepsia (3)Chest Pain (3)Breast Hyperplasia (3)Breast Mass (3)Ovarian Cyst (3)Aortic Stenosis (2)more >>


Page last updated: 2014-11-18

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