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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)

Lynovex activity in cystic fibrosis sputum and against the emerging CF pathogen, Mycobacterium abscessus
Source: Cystic Fibrosis News From Medical News Today [2015.08.14]
In a study published this week in EBioMedicine, Aberdeen Royal Infirmary/University of Aberdeen's Prof Graham Devereux and NovaBiotics demonstrate for the first time, the activity of NovaBiotics...

Postmenopausal women prefer vaginal estrogen to achieve higher sexual quality of life
Source: Endocrinology News From Medical News Today [2015.08.12]
New study demonstrates women's willingness to use vaginal estrogen despite fears of hormones; justifies use of local estrogen in addition to systemic hormone therapyLocal vaginal estrogen (VE)...

Study: universal flu vaccine administered in a trial 3 years ago improves immunogenicity against current flu H3N2 epidemic
Source: Flu / Cold / SARS News From Medical News Today [2015.08.03]
BiondVax Pharmaceuticals Ltd. has announced it received the statistical analysis of results from a study which demonstrates that BiondVax's universal flu vaccine (M-001), administered in the...

Race & institutional factors play an important role in pharmacogenomic trial participation
Source: Clinical Trials / Drug Trials News From Medical News Today [2015.07.28]
White patients and larger well-supported institutions are more likely to have higher participation rates in pharmacogenomic trialsCancer therapy has evolved from a "one-size-fits-all" type of...

Hydrogen Breath Test
Source: MedicineNet Inflammatory Bowel Disease: Intestinal Problems Specialty [2015.05.21]
Title: Hydrogen Breath Test
Category: Procedures and Tests
Created: 1/14/1999 12:00:00 AM
Last Editorial Review: 5/21/2015 12:00:00 AM

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 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.

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

A Bioequivalence Study Of Ethinylestradiol + Gestodene In Female And Healthy Volunteers. [Completed]
A Phase I, Open Label, Randomized, Two-way Crossover, Single Dose Study to Determine the

Bioequivalence of Ethinylestradiol + Gestodene - The objective of the study is to verify

through a single dose study, if the two formulations of Ethinylestradiol 0,02mg + Gestodene 0,075mg sugar coated tablets are bioequivalent when administered at the same dose and under fasting conditions.

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: 2015-08-14

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