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.
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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.
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NEWS HIGHLIGHTS
Published Studies Related to Prometrium (Progesterone Oral)
Effects of nonoral estradiol-micronized progesterone or low-dose oral estradiol-drospirenone therapy on metabolic variables and markers of endothelial function in early postmenopause. [2009.08]
OBJECTIVE: To evaluate the effects of low-dose oral hormone therapy and nonoral hormone therapy on endothelial function markers and on anthropometric, metabolic, and hormonal variables in early postmenopausal women... CONCLUSION(S): Neither treatment induced deleterious effects in the short term on variables related to cardiovascular risk in early postmenopausal women.
Oral micronized progesterone for prevention of preterm birth. [2009.01]
OBJECTIVE: To evaluate oral micronized progesterone (OMP) to prevent preterm birth (PTB)... CONCLUSION: OMP reduced the risk of PTB between 28 and 31 weeks plus 6 days, NICU admissions, and neonatal morbidity and mortality in high risk patients.
Effects of either tibolone or continuous combined transdermal estradiol with medroxyprogesterone acetate on coagulatory factors and lipoprotein(a) in menopause. [2009]
BACKGROUND/AIM: The aim of this prospective controlled study was to compare the effects of two therapies for menopause on factor VII (FVII) and hemostatic variables... CONCLUSION: Our results show that tibolone induces a significant reduction in FVIIc and Lp(a) and a greater enhancement of factors promoting fibrinolysis than the TTS E2/MPA regimen.
Oral micronized progesterone for prevention of preterm birth. [2008.10.15]
OBJECTIVE: To evaluate oral micronized progesterone (OMP) to prevent preterm birth (PTB)... CONCLUSION: OMP reduced the risk of PTB between 28 and 31 weeks plus 6 days, NICU admissions, and neonatal morbidity and mortality in high risk patients.
Clinical and metabolic effects of medroxyprogesterone acetate and ethinyl estradiol plus drospirenone in women with polycystic ovary syndrome. [2008.10]
OBJECTIVES: To investigate the effects of treatment with medroxyprogesterone acetate (MPA), 10 days per month for 6 months, on lipid and carbohydrate metabolism in women with polycystic ovary syndrome (PCOS)... CONCLUSION: Treatment of PCOS patients with MPA provided good menstrual cycle control, beneficial changes in hormonal values associated with hyperandrogenism, and no significant changes in lipid or carbohydrate metabolism.
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]
This multicenter, randomized, open-label study will be performed in approximately 990 healthy
females undergoing IVF. Each study center will follow their study center standard practice
for IVF unless otherwise noted in this protocol. The study centers will be provided with the
medications for down regulation, stimulation and ovulation induction. The subjects will be
randomized to study medication on the day of oocyte retrieval or the day following and will
continue treatment for up to 10 weeks. The subjects with a confirmed pregnancy will be
required to return to the clinic several times during the course of the 10 week treatment
period for serum pregnancy tests and transvaginal ultrasounds to monitor the pregnancy.
Evaluating the Roles of Estrogen and Progesterone in Heart Metabolism [Completed]
Estrogen and progesterone are two main female sex hormones. When a woman goes through
menopause, the body's production of estrogen and progesterone significantly decreases. Recent
studies have shown that the breakdown of fatty acids in cardiac muscle is important in
maintaining a healthy heart, and that estrogen may enhance this process. Also, cardiovascular
disease (CVD) occurs more frequently in postmenopausal women than in premenopausal women.
This study will determine in postmenopausal women whether estrogen increases the heart's
ability to use fats as energy and whether progesterone decreases this effect.
Artificial Endometrial Preparation for Frozen Thawed Embryo Transfer Applying Either Endometrin or Utrogestan [Suspended]
The transfer of frozen-thawed embryos can be performed in a natural ovulatory cycle or in a
hormonally manipulated cycle with a comparable pregnancy rate of 15%-20% per ET. When a
hormonally modulated ET cycle is scheduled,an artificial endometrial preparation is carried
out using estrogen stimulation followed by a concomitant progesterone treatment. Two
progestative drugs are currently used in conventional IVF treatment, Utrogetan and
Endometrin. Although Endometrin has been be efficiently used to support the luteal phase
after embryo transfer in IVF cycles, currently, there is no study that assess its efficacy
for clinical use in frozen-thawed ET cycles. The present study aims to compare the outcome of
frozen thawed ET cycles when either Endometrin or Utrogestan are used as the progestative
substitution in an artificially prepared endometrium.
Progesterone Reduces Wakefulness in Sleep EEG and Has no Effect on Cognition in Healthy Postmenopausal Women [Completed]
Sleep is impaired in postmenopausal women (difficulty falling asleep, frequent awakenings).
Progesterone prompted benzodiazepine-like effects on sleep EEG in young normal male
subjects.
Aim of this study was to test if replacement therapy with progesterone improves sleep after
menopause.
Design, Setting, and Participants: A double blind cross-over design study with 2 treatment
intervals of 21 days duration separated by a 2 weeks washout was performed. A oral dose of
300mg micronized progesterone was given each for 21 days. At the beginning and the end of the
two intervals a sleep EEG was recorded and cognitive performance was assessed in 10 healthy
postmenopausal women (age: 54-70 yrs).
Comparison of Crinone 8% Intravaginal Gel and IM Progesterone Supplementation for In Vitro Fertilization [Recruiting]
The goal of this research study is to compare the pregnancy rates for two different types of
progesterone supplementation after in-vitro fertilization (IVF).
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 3 ratings/reviews, Prometrium has an overall score of 7.33. The effectiveness score is 7.33 and the side effect score is 9.33. 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.
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| 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. |
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| | Prometrium review by 50 year old female patient | | | Rating |
| Overall rating: | | |
| Effectiveness: | | Marginally Effective |
| Side effects: | | Mild Side Effects | | |
Treatment Info |
| Condition / reason: | | perimenopause symptoms |
| Dosage & duration: | | 100 mg taken 1/day for the period of 6 months |
| Other conditions: | | none |
| Other drugs taken: | | none | | |
Reported Results |
| Benefits: | | Decrease in panic attacks (maybe these were hot flashes ... but didn't feel "hot"). Woke up less often at night from these same panic attacks. |
| Side effects: | | Still have headaches - not clear if these are from my sinuses or a side effect, but they have been persistent. Always had problems with sleep, so am not sure if that is affected by the Prometrium. |
| Comments: | | oral medication - presumably the same substance that is found in topical "natural" progesterone cream. |
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| | Prometrium review by 50 year old female patient | | | Rating |
| Overall rating: | | |
| Effectiveness: | | Marginally Effective |
| Side effects: | | Mild Side Effects | | |
Treatment Info |
| Condition / reason: | | perimenopause symptoms |
| Dosage & duration: | | 100 mg taken 1/day for the period of 6 months |
| Other conditions: | | none |
| Other drugs taken: | | none | | |
Reported Results |
| Benefits: | | Decrease in panic attacks (maybe these were hot flashes ... but didn't feel "hot"). Woke up less often at night from these same panic attacks. |
| Side effects: | | Still have headaches - not clear if these are from my sinuses or a side effect, but they have been persistent. Always had problems with sleep, so am not sure if that is affected by the Prometrium. |
| Comments: | | oral medication - presumably the same substance that is found in topical "natural" progesterone cream. |
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Page last updated: 2009-10-20
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