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Prometrium (Progesterone Oral) - Summary

 


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WARNINGS

Progestins and estrogens 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. (See CLINICAL PHARMACOLOGY, Clinical Studies.)

Other doses of oral conjugated estrogens with medroxyprogesterone and other combinations and dosage forms of estrogens and progestins were not studied in the WHI clinical trials. In the absence of comparable data and product-specific studies, the relevance of the WHI findings to other products has not been established. Therefore, the risks should be assumed to be similar for all estrogen and progestin products. 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.

 

PROMETRIUM SUMMARY

PROMETRIUM®
(progesterone, USP)
Capsules 100 mg
Capsules 200 mg

PROMETRIUM® (progesterone, USP) Capsules contain micronized progesterone for oral administration.

PROMETRIUM Capsules are indicated for use in the prevention of endometrial hyperplasia in non-hysterectomized postmenopausal women who are receiving conjugated estrogens tablets. They are also indicated for use in secondary amenorrhea.


See all Prometrium indications & dosage >>

PROMETRIUM NEWS HIGHLIGHTS

Published Studies Related to Prometrium (Progesterone Oral)

Oral micronized progesterone for prevention of preterm birth. [2008.10.15]

Estrogen, medroxyprogesterone acetate, endothelial function, and biomarkers of cardiovascular risk in young women. [2008.04]

Continuous oral or intramuscular medroxyprogesterone acetate versus the levonorgestrel releasing intrauterine system in the treatment of perimenopausal menorrhagia: a randomized, prospective, controlled clinical trial in female smokers. [2008]

Progesterone effects on cocaine use in male cocaine users maintained on methadone: A randomized, double-blind, pilot study. [2007.10]

A comparative study of Cyclofem and depot medroxyprogesterone acetate (DMPA) effects on endometrial vasculature. [2007.10]

more >>

Clinical Trials Related to Prometrium (Progesterone Oral)

Multi-Center, Randomized, Open-Label, Parallel Group Study of a Vaginal Micronized Progesterone Tablet (Endometrin®) Compared to Crinone 8% Vaginal Gel in Female Patients Undergoing In-Vitro Fertilization (IVF) [Completed]

Evaluating the Roles of Estrogen and Progesterone in Heart Metabolism [Completed]

Artificial Endometrial Preparation for Frozen Thawed Embryo Transfer Applying Either Endometrin or Utrogestan [Suspended]

Progesterone Reduces Wakefulness in Sleep EEG and Has no Effect on Cognition in Healthy Postmenopausal Women [Completed]

Comparing IM vs. Vaginal Progesterone for Pre-Term Birth [Recruiting]

more >>

PROMETRIUM PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 1 ratings/reviews, Prometrium 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.
 

Prometrium review by 55 year old female patient

  Rating
Overall rating:  
Effectiveness:   Considerably Effective
Side effects:   No Side Effects
  
Treatment Info
Condition / reason:   menopausal symptoms
Dosage & duration:   100 mg taken once daily for the period of more than a year
Other conditions:   none
Other drugs taken:   menest .625
  
Reported Results
Benefits:   Prometrium is a form of progesterone that helps ameliorate some common menopausal symptoms, including insomnia.
Side effects:   No noticeable side effects were apparent with this medication.
Comments:   The daily dosage was one 100mg. capsule, taken at bedtime. There were no "rest days" with this form of HRT. An annual blood test was recommended, to ensure liver health.

See all Prometrium reviews / ratings >>

Page last updated: 2008-11-02

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